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CompletedNCT01245569FUTUREUpdated Aug 10, 2026Results posted

A Study in Patients With Chronic Obstructive Pulmonary Disease

A Phase 3 interventional study of Beclomethasone Dipropionate - Formoterol and Fluticasone - Salmeterol in Chronic Obstructive Pulmonary Disease, sponsored by Chiesi Farmaceutici S.p.A.. Completed at 68 sites in 10 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Chiesi Farmaceutici S.p.A. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
419
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

The primary objective of the study was to demonstrate the superiority of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), in terms of pulmonary function (AUC0-30min standardized by time of change from pre-dose in FEV1) after drug inhalation in the morning of day 1, and the equivalence between Foster® 100/6 (two puffs b.i.d.) and Seretide® 500/50 (one inhalation b.i.d.) in terms of Transition Dyspnoea Index (TDI) score at day 84 in patients with COPD.

The secondary objectives of the study were:

  • To evaluate the efficacy of the test treatments in terms of additional spirometric parameters and of clinical outcome measures;
  • To assess the safety and tolerability;
  • To perform an exploratory analysis evaluating the consumption of resources deriving from COPD management in the perspective of the Healthcare System.
Read the detailed description

This was a phase IIIb, multicentre, multinational, randomized, double-blind, double-dummy, 2-arm parallel group design preceded by a 2-week run-in period in patients with COPD. The study compared the efficacy and safety of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), over a 12-week treatment period.

The study plan included:

  • A pre-screening visit (V0, at week -3 days before the randomization visit) during which clinical instructions to determine patients' adaptability to the study procedures were given. This could be done only after the participants agreed to participate and signed the Informed Consent form;
  • A screening visit (V1, week -2) in which patients with COPD were selected;
  • A run-in period, lasting from a minimum of 12 to a maximum of 16 days, where patients received a standardised treatment with inhaled aerosol ipratropium bromide (Atrovent® Inhaler CFC-free 20 μg), 1 inhalation four times daily (daily dose of 80 μg) and had any nonpermitted medication withdrawn prior to entry into test treatment period;
  • A randomisation visit (V2, week 0) during which patients were randomly allocated to one of the two treatment arms, and subsequent visits taking place at clinics after 4 (V3), after 8 (V4) and after 12 weeks (V5) of treatment. The end of the trial was defined as the last visit of the last subject on the trial. After 7-10 days of last study medication intake, a follow-up phone contact to document and treat adverse events that might possibly occur was performed.

The total study duration per participant was 16 weeks, including the 2-week run-in period, 12-week treatment phase, and 7-10 days of follow-up.

Salbutamol was used as a rescue medication.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • Foster
  • Seretide
  • COPD
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 419 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Chiesi Farmaceutici S.p.A. is the lead sponsor of 182 studies on the registry; 22 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 11 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  1. Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or once applicable written informed consent obtained by legal representative.

  2. Outpatients with a diagnosis of COPD and including:

    1. Smoking history of at least 10 pack years defined as [(number of cigarettes smoked per day) x (number of years of smoking) / 20], both current and ex-smokers are eligible.
    2. Use of bronchodilators in the previous 2 months to visit 1.
    3. Post-bronchodilator FEV1 \< 60% of the predicted normal value.
    4. Post-bronchodilator FEV1/FVC \< 0.7.
    5. A ≥ 5% response to a reversibility test.
    6. A Baseline Dyspnoea Index (BDI) focal score less or equal than 10 (to be met also at visit 2).
  3. History of no more than one COPD exacerbation in the previous 12 months (without considering the last 2 months) to visit 1.
  4. A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Accuhaler®, circular moulded plastic inhaler) inhalers.

Main Exclusion Criteria:

  1. Diagnosis of asthma or respiratory disorders (other than COPD) which could interfere with data interpretation according to the investigator's opinion.

  2. Pregnant or lactating women. Females of childbearing potential without an efficient contraception UNLESS they met the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or were using one or more of the following acceptable methods of contraception:

    1. Surgical sterilization (e.g., bilateral tubal ligation, hysterectomy);
    2. Hormonal contraception (implantable, patch, oral, injectable);
    3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
    4. Continuous abstinence (e.g. nuns). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception. Reliable contraception should have been maintained throughout the study and for 30 days after study drug discontinuation.
  3. Clinical or functional unstable concurrent disease: e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. uncontrolled coronary artery disease, hypertension, heart failure); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other which could impact the evaluation of the results of the study according to investigator's judgement.
  4. Patient with narrow-angle glaucoma.
  5. Clinically significant laboratory and ECG abnormalities indicating a significant or unstable concomitant disease which could impact the evaluation of the results of the study and the safety of the patient according to investigator's judgement.
  6. Patients with COPD exacerbation (see previous at inclusion criteria no. 3) in the 2 months prior to screening and during the study period.
  7. Patients requiring long term (> 12 hours daily) oxygen therapy for chronic hypoxemia.
  8. Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period.
  9. Patients with known allergy, sensitivity or intolerance to sympathomimetic drugs or inhaled corticosteroids or to any of the excipients contained in the study drugs.
  10. Patients who had evidence of alcohol or drug abuse, who were not compliant with the study protocol or not compliant with the study treatments according to investigator's judgement.
  11. Major surgery in the previous 3 months and during the trial which could affect patient's compliance in the study procedures (e.g. spirometry).
  12. Participation in another clinical trial with an investigational drug in the 2 months preceding visit 1.
  13. Patients requiring chronic mechanical ventilation for COPD
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
419 participants (actual)

Study arms

  • Experimental
    Foster®

    Participants received 2 puffs of Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose) administered via a pMDI twice daily (BID), resulting in a total daily dose of beclomethasone dipropionate 400 μg plus formoterol 24 μg, for a duration of 12 weeks. To ensure blinding, participants received one inhalation of placebo matching Seretide® Accuhaler® via a inhaler BID, for a duration of 12 weeks.

    Drug: Beclomethasone Dipropionate - Formoterol

  • Active comparator
    Seretide® Accuhaler®

    Participants received one inhalation of Seretide® Accuhaler® (fluticasone 500 μg plus salmeterol 50 μg/actuation) administered via inhaler, BID resulting in a total daily dose of fluticasone 1000 μg plus salmeterol 100 μg, for a duration of 12 weeks. To ensure blinding, participants receieved two puffs of placebo matching Foster® via pMDI, BID for a duration of 12 weeks.

    Drug: Fluticasone - Salmeterol

Interventions

  • DrugBeclomethasone Dipropionate - Formoterol

    Administered via a pressurized metered-dose inhaler

    Also known as: Foster

  • DrugFluticasone - Salmeterol

    Administered via a pressurized metered-dose inhaler

    Also known as: Seretide Accuhaler®

06

What researchers measure

Primary outcomes

  1. Area Under the Curve (AUC) 0-30min Standardized by Time of Change From Pre-dose in Forced Expiratory Volume in One Second (FEV1) in the Morning of Day 1

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessment were implemented at pre-dose, and 5, 15 and 30 minutes post inhalation

    Time frame: on Day 1 (V2)

  2. Transition Dyspnoea Index (TDI) Score at Day 84

    TDI has three domains as follows: 1. Functional impairment, which determines the impact of breathlessness on the ability to carry out activities; 2. Magnitude of task, which determines the type of task that causes breathlessness; 3. Magnitude of effort, which establishes the level of effort that results in breathlessness The TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain. The sum of all domains yields the TDI focal score of -9 (major deterioration) to +9 (major improvement). Adjusted means were reported.

    Time frame: Day 84 (V5)

Secondary outcomes

  1. AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessments were implemented pre-dose, 5, 15 and 30 minutes post inhalation.

    Time frame: on Day 84 (V5)

  2. AUC 0-30min Standardized by Time of Change From Baseline in FEV1 After Drug Inhalation in the Morning of Day 84

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessments were implemented at baseline and 5,15 and 30 minutes post inhalation.

    Time frame: on Day 84 (V5)

  3. Change From Baseline (CFB) in Pre-dose Morning FEV1

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.

    Time frame: Weeks 4, 8 and 12

  4. Change From Baseline in Pre-dose Morning Forced Vital Capacity (FVC)

    FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits. Higher values indicate improved lung capacity and reduced airway obstruction. Adjusted means were reported.

    Time frame: Weeks 4, 8 and 12

  5. Change From Pre-dose in Morning FEV1 at 5, 15 and 30 Min After Drug Intake

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.

    Time frame: 5, 15, 30 Min post inhalation at Weeks 0 (V2) and 12 (Day 84, V5)

  6. Change From Baseline in Morning FEV1 at 5, 15 and 30 Min After Drug Intake

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.

    Time frame: at 5, 15 and 30 mins post inhalation at Week 12 (Day 84, V5)

  7. Change From Pre-dose in Morning FVC at 5, 15 and 30 Min After Drug Intake

    FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits. Higher values indicate improved lung capacity and reduced airway obstruction. Adjusted means were reported.

    Time frame: at 5, 15 and 30 min post inhalation Week 0 (V2) & Week 12 Day 84, (V5)

  8. Change From Baseline to Each Two-Week Period in COPD Symptom Scores

    COPD symptom scores consists of following 6 items recorded by the participants in diary. * the ability to perform the usual daily activities; * breathlessness over the previous 24h; * waking at night due to respiratory symptoms; * breathlessness on rising; * cough over the previous 24h; * sputum production over the previous 24h. Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst). Baseline COPD symptom score has been calculated as the mean of the COPD symptom scores recorded in the run-in period. Each item or total scores were averaged over each 2 week period. Average COPD symptom score in each two-week period has been calculated as the mean of the item or total score recorded in each two-week period. Adjusted means were reported.

    Time frame: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

  9. Change From Baseline to Each Two-Week Period in Percentage of COPD Symptom-Free Days

    COPD symptom scores consists of following 6 items recorded by the participants in diary. * ability to perform the usual daily activities; * breathlessness over the previous 24h; * waking at night due to respiratory symptoms; * breathlessness on rising; * cough over the previous 24h; * sputum production over the previous 24h. Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst). A COPD symptom-free day is a day with total COPD symptom scores = 0. Baseline % of COPD symptom-free days is calculated as the % ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)\*100. Reported values (in form of adjusted means) reflect a percentage (%). % of COPD symptom-free days in each two-week period is calculated as % (ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)\*100.

    Time frame: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

  10. Change From Baseline to Entire Treatment Period in Percentage of COPD Symptom-Free Days

    COPD symptom scores consists of following 6 items recorded by the participants in diary. * ability to perform the usual daily activities; * breathlessness over the previous 24h; * waking at night due to respiratory symptoms; * breathlessness on rising; * cough over the previous 24h; * sputum production over the previous 24h. Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst). A COPD symptom-free day is a day with total COPD symptom scores = 0. Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of COPD symptom-free days is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)\*100. % of COPD symptom-free days in each two-week period is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)\*100.

    Time frame: Baseline, Weeks 1 through 12

  11. Change From Baseline to Each Two-Week Period in Average Use of Rescue Salbutamol Consumption

    Number of rescue salbutamol puffs per day were recorded in the diary. Baseline use of rescue medication has been calculated as the mean number of puffs per day in the run-in period. Average use of rescue medication in each two-week period has been calculated as the mean number of puffs per day in each two week period. Adjusted means were reported.

    Time frame: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

  12. Change From Baseline to Each Two-Week Period in Percentage of Rescue Salbutamol-Free Days

    A rescue medication-free day is a day with number of puffs of rescue medication = 0. Reported values (in form of adjusted means) reflect a percentage (%). Baseline percentage (%) of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)\*100. % of rescue medication-free days in each two-week period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the two-week period)\*100.

    Time frame: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

  13. Change From Baseline to Entire Treatment Period in Percentage of Rescue Salbutamol-Free Days

    A rescue medication-free day is a day with number of puffs of rescue medication = 0. Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)\*100. % of rescue medication-free days in the entire treatment period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the entire treatment period)\*100.

    Time frame: at week 12 (V5)

  14. Change From Baseline in the St George's Respiratory Questionnaire (SGRQ) Component and Total Scores

    SGRQ is a 76-item questionnaire developed to measure health in chronic airflow limitation and designed to be self-completed by the participant. It consists of 76-items across three domains: * Symptoms, which evaluates the frequency and severity of respiratory issues like coughing, sputum production, and breathlessness; * Activity, which measures limitations in physical activities due to breathlessness; * Impacts, which examines psychological and social effects, including feelings of stigma, loss of control, and daily life disruption. Each domain score ranges from 0 to 100 with higher scores indicating the worst health status. Total score was obtained by combining the weighted scores from each domain and ranging from 0 (better health) to 100 (Worst health).

    Time frame: at Week 12 (V5)

  15. Change From Baseline in Pre-dose and in Post-dose Distance Walked (6 Minute Walking Test - 6MWT)

    The 6MWT was carried out following standardized procedures, according to ATS guidelines. The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test. Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes. The patients sit at rest for at least 10 minutes before the test start. The longer distance covered, the better the outcome.

    Time frame: Week 12 (V5), pre-dose and post-dose

  16. Change From Pre-dose in Post-dose Distance Walked (6MWT)

    The 6MWT was carried out following standardized procedures, according to ATS guidelines. The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test. Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes. The patients sit at rest for at least 10 minutes before the test start.

    Time frame: on Week 0 (Day 1, V2) and Week 12 (V5, Day 84)

  17. Number of Participants With COPD Exacerbations From Week 0 Through Week 12

    A COPD exacerbation is defined as "a sustained worsening of the participants condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and requires unscheduled medical intervention \[leading to prescriptions of systemic corticosteroids (at least 3 days)\] and/or antibiotics (at least 5 days), or need for a visit to an emergency department or hospitalization) in a participant with underlying COPD".

    Time frame: Week 12

  18. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    AE=An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine. Serious AE= An adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. ADR=A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility Serious ADR=An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. Severe AE= "Severe" refers to the intensity of an AE; the event itself may be of relatively minor medical significance but intense.

    Time frame: From first dose of study drug until end of the treatment (up to 84 days)

07

Results

Posted Aug 10, 2026

Participant flow

Participants were enrolled across 70 centers in 10 countries. A total of 675 participants were screened for eligibility; 256 participants were screen failure and 419 were enrolled and randomized in this study.

Participant flow — Overall Study
MilestoneFoster®Seretide® Accuhaler®
Started211208
Itt population211207
Safety population211208
Completed192181
Not completed1927
Withdrew: Adverse event23
Withdrew: Development of exclusion criteria610
Withdrew: Treatment failure01
Withdrew: Withdrawal by subject43
Withdrew: Protocol violation57
Withdrew: Lost to follow-up12
Withdrew: Miscellaneous11

Outcome measures

PrimaryArea Under the Curve (AUC) 0-30min Standardized by Time of Change From Pre-dose in Forced Expiratory Volume in One Second (FEV1) in the Morning of Day 1

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessment were implemented at pre-dose, and 5, 15 and 30 minutes post inhalation

Time frame:
on Day 1 (V2)
Reported as:
Mean · Liters
Area Under the Curve (AUC) 0-30min Standardized by Time of Change From Pre-dose in Forced Expiratory Volume in One Second (FEV1) in the Morning of Day 1
LitersFoster®Seretide® Accuhaler®
Area Under the Curve (AUC) 0-30min Standardized by Time of Change From Pre-dose in Forced Expiratory Volume in One Second (FEV1) in the Morning of Day 10.177 (0.160 to 0.194)0.105 (0.087 to 0.122)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · ANCOVA · p = <0.001 (Analysis was based on an ANCOVA model with AUC0-30min standardized by time of change from pre-dose in FEV1 at Day 1 as dependent variable, treatment and country as fixed effects and baseline (pre-dose morning FEV1 at Day 1) as a covariate.) · Adjusted mean difference: 0.073 · 95% CI 0.050 to 0.095
PrimaryTransition Dyspnoea Index (TDI) Score at Day 84

TDI has three domains as follows: 1. Functional impairment, which determines the impact of breathlessness on the ability to carry out activities; 2. Magnitude of task, which determines the type of task that causes breathlessness; 3. Magnitude of effort, which establishes the level of effort that results in breathlessness The TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain. The sum of all domains yields the TDI focal score of -9 (major deterioration) to +9 (major improvement). Adjusted means were reported.

Time frame:
Day 84 (V5)
Reported as:
Mean · score on a scale
Transition Dyspnoea Index (TDI) Score at Day 84
score on a scaleFoster®Seretide® Accuhaler®
Transition Dyspnoea Index (TDI) Score at Day 841.149 (0.680 to 1.619)1.041 (0.570 to 1.512)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · ANCOVA · p = 0.705 (Analysis is based on an ANCOVA model with TDI score at Day 84 as dependent variable, treatment and country as fixed effects and baseline (BDI score at Day 1) as a covariate.) · Adjusted mean difference: 0.108 · 95% CI -0.454 to 0.670
SecondaryAUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessments were implemented pre-dose, 5, 15 and 30 minutes post inhalation.

Time frame:
on Day 84 (V5)
Reported as:
Mean · Liters
AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84
LitersFoster®Seretide® Accuhaler®
AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 840.138 (0.123 to 0.152)0.066 (0.051 to 0.080)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · ANCOVA · p = <0.001 (Analysis was based on an ANCOVA model with AUC0-30min standardized by time of change from pre-dose in FEV1 at Day 84 as dependent variable, treatment and country as fixed effects and baseline (pre-dose morning FEV1 at Day 84) as a covariate.) · Adjusted mean difference: 0.072 · 95% CI 0.054 to 0.091
SecondaryAUC 0-30min Standardized by Time of Change From Baseline in FEV1 After Drug Inhalation in the Morning of Day 84

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessments were implemented at baseline and 5,15 and 30 minutes post inhalation.

Time frame:
on Day 84 (V5)
Reported as:
Mean · Liters
AUC 0-30min Standardized by Time of Change From Baseline in FEV1 After Drug Inhalation in the Morning of Day 84
LitersFoster®Seretide® Accuhaler®
AUC 0-30min Standardized by Time of Change From Baseline in FEV1 After Drug Inhalation in the Morning of Day 840.217 (0.183 to 0.252)0.136 (0.100 to 0.172)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · ANCOVA · p = <0.001 (Analysis is based on an ANCOVA model with AUC0-30min standardized by time of change from pre-dose in FEV1 at Day 84 as dependent variable, treatment and country as fixed effects and baseline (pre-dose morning FEV1 at Day 1) as a covariate.) · Adjusted mean difference: 0.081 · 95% CI 0.036 to 0.126
SecondaryChange From Baseline (CFB) in Pre-dose Morning FEV1

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.

Time frame:
Weeks 4, 8 and 12
Reported as:
Mean · Liters
Change From Baseline (CFB) in Pre-dose Morning FEV1
LitersFoster®Seretide® Accuhaler®
Week 40.102 (0.073 to 0.131)0.088 (0.057 to 0.118)
Week 80.098 (0.066 to 0.129)0.088 (0.056 to 0.121)
Week 120.077 (0.044 to 0.110)0.064 (0.031 to 0.098)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.467 (Linear MMRM with CFB in pre-dose morning FEV1 at each visit as dependent variable, treatment, visit, treatment x visit interaction \& country as fixed effects \& baseline (pre-dose morning FEV1 at Week 0) \& baseline x visit interaction as covariates.) · Adjusted mean difference: 0.014 · 95% CI -0.024 to 0.053An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.659 (Linear MMRM with CFB in pre-dose morning FEV1 at each visit as dependent variable, treatment, visit, treatment x visit interaction \& country as fixed effects \& baseline (pre-dose morning FEV1 at Week 0) \& baseline x visit interaction as covariates.) · Adjusted mean difference: 0.009 · 95% CI -0.032 to 0.051An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.575 (Linear MMRM with CFB in pre-dose morning FEV1 at each visit as dependent variable, treatment, visit, treatment x visit interaction \& country as fixed effects \& baseline (pre-dose morning FEV1 at Week 0) \& baseline x visit interaction as covariates.) · Adjusted mean difference: 0.013 · 95% CI -0.031 to 0.056
SecondaryChange From Baseline in Pre-dose Morning Forced Vital Capacity (FVC)

FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits. Higher values indicate improved lung capacity and reduced airway obstruction. Adjusted means were reported.

Time frame:
Weeks 4, 8 and 12
Reported as:
Mean · Liters
Change From Baseline in Pre-dose Morning Forced Vital Capacity (FVC)
LitersFoster®Seretide® Accuhaler®
Week 40.165 (0.109 to 0.221)0.123 (0.065 to 0.181)
Week 80.113 (0.053 to 0.173)0.110 (0.049 to 0.172)
Week 120.064 (-0.000 to 0.129)0.054 (-0.012 to 0.120)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.262 (Linear MMRM with CFB in pre-dose morning FVC at each visit as dependent variable, treatment, visit, treatment x visit interaction \& country as fixed effects \& baseline (pre-dose morning FVC at Week 0) \& baseline x visit interaction as covariates.) · Adjusted mean difference: 0.042 · 95% CI -0.032 to 0.116An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.950 (Linear MMRM with CFB in pre-dose morning FVC at each visit as dependent variable, treatment, visit, treatment x visit interaction \& country as fixed effects \& baseline (pre-dose morning FVC at Week 0) \& baseline x visit interaction as covariates.) · Adjusted mean difference: 0.003 · 95% CI -0.077 to 0.082An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.819 (Linear MMRM with CFB in pre-dose morning FVC at each visit as dependent variable, treatment, visit, treatment x visit interaction \& country as fixed effects \& baseline (pre-dose morning FVC at Week 0) \& baseline x visit interaction as covariates.) · Adjusted mean difference: 0.010 · 95% CI -0.077 to 0.097An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
SecondaryChange From Pre-dose in Morning FEV1 at 5, 15 and 30 Min After Drug Intake

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.

Time frame:
5, 15, 30 Min post inhalation at Weeks 0 (V2) and 12 (Day 84, V5)
Reported as:
Mean · Liters
Change From Pre-dose in Morning FEV1 at 5, 15 and 30 Min After Drug Intake
LitersFoster®Seretide® Accuhaler®
Week 0: 5 Minutes Post Inhalation0.162 (0.144 to 0.179)0.078 (0.060 to 0.096)
Week 0: 15 Minutes Post Inhalation0.197 (0.177 to 0.216)0.127 (0.107 to 0.146)
Week 0: 30 Minutes Post Inhalation0.208 (0.187 to 0.228)0.138 (0.117 to 0.159)
Week 12: 5 Minutes Post Inhalation0.133 (0.117 to 0.148)0.043 (0.027 to 0.058)
Week 12:15 Minutes Post Inhalation0.153 (0.137 to 0.170)0.077 (0.060 to 0.094)
Week 12: 30 Minutes Post Inhalation0.161 (0.142 to 0.180)0.087 (0.068 to 0.107)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = <0.001 (Linear MMRM with CFP morning FEV1 at each TP at Week 0 (V2) as dependent variable, treatment, TP, treatment x TP interaction and country as fixed effects and baseline (predose morning FEV1 at Week 0) and baseline x TP interaction as covariates.) · Adjusted mean difference: 0.083 · 95% CI 0.060 to 0.107An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = <0.001 (Linear MMRM with CFP morning FEV1 at each TP at Week 0 (V2) as dependent variable, treatment, TP, treatment x TP interaction and country as fixed effects and baseline (predose morning FEV1 at Week 0) and baseline x TP interaction as covariates.) · Adjusted mean difference: 0.070 · 95% CI 0.044 to 0.095An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = <0.001 (Linear MMRM with CFP morning FEV1 at each TP at Week 0 (V2) as dependent variable, treatment, TP, treatment x TP interaction and country as fixed effects and baseline (predose morning FEV1 at Week 0) and baseline x TP interaction as covariates.) · Adjusted mean difference: 0.070 · 95% CI 0.042 to 0.098
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = <0.001 (Linear MMRM with CFP morning FEV1 at each timepoint (TP) at Week 12 (V5) as dependent variable, treatment, TP, treatment x TP interaction \& country as fixed effects \& baseline (predose morning FEV1 at V5) \& baseline x TP interaction as covariates.) · Adjusted mean difference: 0.090 · 95% CI 0.070 to 0.110An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = <0.001 (Linear MMRM with CFP morning FEV1 at each timepoint (TP) at Week 12 (V5) as dependent variable, treatment, TP, treatment x TP interaction \& country as fixed effects \& baseline (predose morning FEV1 at V5) \& baseline x TP interaction as covariates.) · Adjusted mean difference: 0.076 · 95% CI 0.054 to 0.098An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = <0.001 (Linear MMRM with CFP morning FEV1 at each timepoint (TP) at Week 12 (V5) as dependent variable, treatment, TP, treatment x TP interaction \& country as fixed effects \& baseline (predose morning FEV1 at V5) \& baseline x TP interaction as covariates.) · Adjusted mean difference: 0.074 · 95% CI 0.049 to 0.100An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
SecondaryChange From Baseline in Morning FEV1 at 5, 15 and 30 Min After Drug Intake

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.

Time frame:
at 5, 15 and 30 mins post inhalation at Week 12 (Day 84, V5)
Reported as:
Mean · Liters
Change From Baseline in Morning FEV1 at 5, 15 and 30 Min After Drug Intake
LitersFoster®Seretide® Accuhaler®
5 Minute Post-Inhalation0.212 (0.179 to 0.246)0.113 (0.078 to 0.148)
15 Minute Post-Inhalation0.233 (0.198 to 0.267)0.148 (0.112 to 0.183)
30 Minute Post-Inhalation0.241 (0.204 to 0.278)0.157 (0.119 to 0.195)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = <0.001 (Linear MMRM with CFB in morning FEV1 at each timepoint (TP) at Week 12 as dependent variable, treatment, TP, treatment x TP interaction \& country as fixed effects \& baseline (pre-dose morning FEV1 at Week 0) \& baseline x TP interaction as covariates.) · Adjusted mean difference: 0.099 · 95% CI 0.055 to 0.143An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = <0.001 (Linear MMRM with CFB in morning FEV1 at each timepoint (TP) at Week 12 as dependent variable, treatment, TP, treatment x TP interaction \& country as fixed effects \& baseline (pre-dose morning FEV1 at Week 0) \& baseline x TP interaction as covariates.) · Adjusted mean difference: 0.085 · 95% CI 0.040 to 0.130An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = <0.001 (Linear MMRM with CFB in morning FEV1 at each timepoint (TP) at Week 12 as dependent variable, treatment, TP, treatment x TP interaction \& country as fixed effects \& baseline (pre-dose morning FEV1 at Week 0) \& baseline x TP interaction as covariates.) · Adjusted mean difference: 0.084 · 95% CI 0.035 to 0.133An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
SecondaryChange From Pre-dose in Morning FVC at 5, 15 and 30 Min After Drug Intake

FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits. Higher values indicate improved lung capacity and reduced airway obstruction. Adjusted means were reported.

Time frame:
at 5, 15 and 30 min post inhalation Week 0 (V2) & Week 12 Day 84, (V5)
Reported as:
Mean · Liters
Change From Pre-dose in Morning FVC at 5, 15 and 30 Min After Drug Intake
LitersFoster®Seretide® Accuhaler®
Week 0: 5 Minutes Post-Inhalation0.331 (0.285 to 0.377)0.159 (0.112 to 0.206)
Week 0: 15 Minutes Post-Inhalation0.351 (0.303 to 0.398)0.246 (0.198 to 0.295)
Week 0: 30 Minutes Post-Inhalation0.368 (0.317 to 0.419)0.272 (0.220 to 0.324)
Week 12: 5 Minutes Post-Inhalation0.260 (0.222 to 0.298)0.067 (0.028 to 0.107)
Week 12: 15 Minutes Post-Inhalation0.298 (0.256 to 0.339)0.125 (0.082 to 0.167)
Week 12: 30 Minutes Post-Inhalation0.347 (0.284 to 0.410)0.169 (0.104 to 0.234)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = <0.001 (Linear MMRM with CFP morning FVC at each Time point (TP) at Week 0 as dependent variable, treatment, TP, treatment x TP interaction and country as fixed effects and baseline (predose morning FVC at Week 0) and baseline x TP interaction as covariates.) · Adjusted mean difference: 0.172 · 95% CI 0.112 to 0.233An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.001 (Linear MMRM with CFP morning FVC at each Time point (TP) at Week 0 as dependent variable, treatment, TP, treatment x TP interaction and country as fixed effects and baseline (predose morning FVC at Week 0) and baseline x TP interaction as covariates.) · Adjusted mean difference: 0.104 · 95% CI 0.041 to 0.167An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.06 (Linear MMRM with CFP morning FVC at each Time point (TP) at Week 0 as dependent variable, treatment, TP, treatment x TP interaction and country as fixed effects and baseline (predose morning FVC at Week 0) and baseline x TP interaction as covariates.) · Adjusted mean difference: 0.097 · 95% CI 0.028 to 0.165An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = <0.001 (Linear MMRM with CFP in morning FVC at each timepoint (TP) at Week 12 as dependent variable, treatment, TP, treatment x TP interaction \& country as fixed effects \& baseline (predose morning FVC at Week 12) \& baseline x TP interaction as covariates.) · Adjusted mean difference: 0.193 · 95% CI 0.143 to 0.243An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = <0.001 (Linear MMRM with CFP in morning FVC at each timepoint (TP) at Week 12 as dependent variable, treatment, TP, treatment x TP interaction \& country as fixed effects \& baseline (predose morning FVC at Week 12) \& baseline x TP interaction as covariates.) · Adjusted mean difference: 0.173 · 95% CI 0.118 to 0.228An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = <0.001 (Linear MMRM with CFP in morning FVC at each timepoint (TP) at Week 12 as dependent variable, treatment, TP, treatment x TP interaction \& country as fixed effects \& baseline (predose morning FVC at Week 12) \& baseline x TP interaction as covariates.) · Adjusted mean difference: 0.178 · 95% CI 0.091 to 0.265An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
SecondaryChange From Baseline to Each Two-Week Period in COPD Symptom Scores

COPD symptom scores consists of following 6 items recorded by the participants in diary. * the ability to perform the usual daily activities; * breathlessness over the previous 24h; * waking at night due to respiratory symptoms; * breathlessness on rising; * cough over the previous 24h; * sputum production over the previous 24h. Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst). Baseline COPD symptom score has been calculated as the mean of the COPD symptom scores recorded in the run-in period. Each item or total scores were averaged over each 2 week period. Average COPD symptom score in each two-week period has been calculated as the mean of the item or total score recorded in each two-week period. Adjusted means were reported.

Time frame:
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Reported as:
Mean · Score on a Scale
Change From Baseline to Each Two-Week Period in COPD Symptom Scores
Score on a ScaleFoster®Seretide® Accuhaler®
Total Score: Week 1-2-1.170 (-1.479 to -0.862)-0.782 (-1.094 to -0.470)
Total Score: Week 3-4-1.153 (-1.491 to -0.815)-0.880 (-1.222 to -0.538)
Total Score: Week 5-6-1.115 (-1.446 to -0.783)-0.916 (-1.252 to -0.579)
Total Score: Week 7-8-1.075 (-1.414 to -0.736)-1.097 (-1.441 to -0.752)
Total Score: Week 9-10-1.168 (-1.502 to -0.834)-1.000 (-1.338 to -0.661)
Total Score: Week 11-12-1.209 (-1.550 to -0.868)-1.000 (-1.346 to -0.654)
Ability to Perform the Usual Daily Activities: Week 1-2-0.174 (-0.253 to -0.095)-0.096 (-0.176 to -0.016)
Ability to Perform the Usual Daily Activities: Week 3-4-0.150 (-0.234 to -0.066)-0.105 (-0.190 to -0.020)
Ability to Perform the Usual Daily Activities: Week 5-6-0.136 (-0.217 to -0.055)-0.121 (-0.204 to -0.039)
Ability to Perform the Usual Daily Activities: Week 7-8-0.145 (-0.228 to -0.063)-0.124 (-0.208 to -0.040)
Ability to Perform the Usual Daily Activities: Week 9-10-0.194 (-0.277 to -0.111)-0.105 (-0.190 to -0.021)
Ability to Perform the Usual Daily Activities: Week 11-12-0.188 (-0.274 to -0.101)-0.094 (-0.181 to -0.006)
Breathlessness: Week 1-2-0.319 (-0.392 to -0.246)-0.197 (-0.271 to -0.123)
Breathlessness: Week 3-4-0.308 (-0.387 to -0.229)-0.196 (-0.276 to -0.116)
Breathlessness: Week 5-6-0.332 (-0.410 to -0.254)-0.234 (-0.313 to -0.155)
Breathlessness: Week 7-8-0.295 (-0.376 to -0.214)-0.274 (-0.357 to -0.192)
Breathlessness: Week 9-10-0.285 (-0.364 to -0.205)-0.233 (-0.314 to -0.152)
Breathlessness: Week 11-12-0.264 (-0.347 to -0.182)-0.239 (-0.323 to -0.155)
Waking at Night Due to Respiratory Symptoms: Week 1-2-0.099 (-0.161 to -0.036)-0.058 (-0.122 to 0.005)
Waking at Night Due to Respiratory Symptoms: Week 3-4-0.102 (-0.170 to -0.035)-0.060 (-0.129 to 0.008)
Waking at Night Due to Respiratory Symptoms: Week 5-6-0.104 (-0.169 to -0.038)-0.089 (-0.156 to -0.023)
Waking at Night Due to Respiratory Symptoms: Week 7-8-0.102 (-0.166 to -0.037)-0.097 (-0.163 to -0.032)
Waking at Night Due to Respiratory Symptoms: Week 9-10-0.101 (-0.167 to -0.036)-0.103 (-0.170 to -0.036)
Waking at Night Due to Respiratory Symptoms: Week 11-12-0.098 (-0.168 to -0.028)-0.087 (-0.159 to -0.016)
Breathlessness on Rising: Week 1-2-0.179 (-0.252 to -0.105)-0.124 (-0.199 to -0.050)
Breathlessness on Rising: Week 3-4-0.194 (-0.272 to -0.116)-0.143 (-0.223 to -0.063)
Breathlessness on Rising: Week 5-6-0.202 (-0.279 to -0.125)-0.156 (-0.234 to -0.077)
Breathlessness on Rising: Week 7-8-0.199 (-0.279 to -0.119)-0.169 (-0.251 to -0.087)
Breathlessness on Rising: Week 9-10-0.206 (-0.287 to -0.126)-0.178 (-0.260 to -0.095)
Breathlessness on Rising: Week 11-12-0.206 (-0.286 to -0.127)-0.174 (-0.255 to -0.093)
Cough: Week 1-2-0.215 (-0.285 to -0.144)-0.160 (-0.232 to -0.089)
Cough: Week 3-4-0.220 (-0.298 to -0.142)-0.208 (-0.287 to -0.129)
Cough: Week 5-6-0.195 (-0.274 to -0.116)-0.202 (-0.282 to -0.122)
Cough: Week 7-8-0.194 (-0.275 to -0.112)-0.257 (-0.340 to -0.174)
Cough: Week 9-10-0.221 (-0.301 to -0.141)-0.242 (-0.323 to -0.161)
Cough: Week 11-12-0.249 (-0.330 to -0.168)-0.264 (-0.346 to -0.181)
Sputum: Production Week 1-2-0.173 (-0.242 to -0.104)-0.150 (-0.220 to -0.080)
Sputum Production: Week 3-4-0.156 (-0.230 to -0.082)-0.193 (-0.269 to -0.118)
Sputum Production: Week 5-6-0.171 (-0.248 to -0.093)-0.142 (-0.220 to -0.063)
Sputum Production: Week 7-8-0.173 (-0.250 to -0.095)-0.193 (-0.272 to -0.114)
Sputum Production: Week 9-10-0.184 (-0.261 to -0.106)-0.144 (-0.222 to -0.066)
Sputum Production: Week 11-12-0.228 (-0.309 to -0.148)-0.159 (-0.241 to -0.077)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.057 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.388 · 95% CI -0.789 to 0.012An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.231 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.273 · 95% CI -0.720 to 0.174An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.371 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.199 · 95% CI -0.636 to 0.238An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.924 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: 0.022 · 95% CI -0.427 to 0.471An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.452 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.169 · 95% CI -0.609 to 0.272An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.364 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.209 · 95% CI -0.660 to 0.243An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.136 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.078 · 95% CI -0.181 to 0.025An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.425 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.045 · 95% CI -0.156 to 0.066An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.785 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.015 · 95% CI -0.121 to 0.092An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.699 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.021 · 95% CI -0.130 to 0.087An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.111 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.089 · 95% CI -0.198 to 0.020An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.108 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.094 · 95% CI -0.208 to 0.021An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.012 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.122 · 95% CI -0.218 to -0.026An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.037 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.112 · 95% CI -0.217 to -0.007An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.061 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.098 · 95% CI -0.201 to 0.005An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.704 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.021 · 95% CI -0.129 to 0.087An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.339 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.051 · 95% CI -0.157 to 0.054An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.650 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.025 · 95% CI -0.135 to 0.084
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.338 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.040 · 95% CI -0.123 to 0.042An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.358 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.042 · 95% CI -0.132 to 0.048An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.744 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.014 · 95% CI -0.101 to 0.072An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.917 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.004 · 95% CI -0.089 to 0.080An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.968 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: 0.002 · 95% CI -0.085 to 0.089
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.822 (Linear MMRM with CFB to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.011 · 95% CI -0.104 to 0.083
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.265 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.054 · 95% CI -0.150 to 0.041An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.336 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.051 · 95% CI -0.154 to 0.053An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.367 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.046 · 95% CI -0.148 to 0.055An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.576 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.030 · 95% CI -0.137 to 0.076An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.600 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.029 · 95% CI -0.136 to 0.079An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.542 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.033 · 95% CI -0.138 to 0.072An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.249 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.054 · 95% CI -0.146 to 0.038
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.811 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.013 · 95% CI -0.116 to 0.091An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.897 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: 0.007 · 95% CI -0.098 to 0.112An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.253 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: 0.063 · 95% CI -0.045 to 0.172An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.704 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: 0.015 · 95% CI -0.093 to 0.123An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.784 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: 0.015 · 95% CI -0.093 to 0.123An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.609 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.023 · 95% CI -0.113 to 0.067An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.455 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: 0.037 · 95% CI -0.061 to 0.136An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.579 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.029 · 95% CI -0.132 to 0.074An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.704 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: 0.020 · 95% CI -0.084 to 0.124An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.449 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.040 · 95% CI -0.142 to 0.063An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.207 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.069 · 95% CI -0.177 to 0.038An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
SecondaryChange From Baseline to Each Two-Week Period in Percentage of COPD Symptom-Free Days

COPD symptom scores consists of following 6 items recorded by the participants in diary. * ability to perform the usual daily activities; * breathlessness over the previous 24h; * waking at night due to respiratory symptoms; * breathlessness on rising; * cough over the previous 24h; * sputum production over the previous 24h. Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst). A COPD symptom-free day is a day with total COPD symptom scores = 0. Baseline % of COPD symptom-free days is calculated as the % ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)\*100. Reported values (in form of adjusted means) reflect a percentage (%). % of COPD symptom-free days in each two-week period is calculated as % (ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)\*100.

Time frame:
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Reported as:
Mean · percentage of days
Change From Baseline to Each Two-Week Period in Percentage of COPD Symptom-Free Days
percentage of daysFoster®Seretide® Accuhaler®
Week 1-24.067 (1.170 to 6.964)5.846 (2.873 to 8.818)
Week 3-45.373 (2.318 to 8.429)6.085 (2.951 to 9.220)
Week 5-64.503 (1.388 to 7.619)4.739 (1.538 to 7.941)
Week 7-83.944 (0.855 to 7.032)6.182 (3.007 to 9.357)
Week 9-104.880 (1.576 to 8.184)6.470 (3.069 to 9.870)
Week 11-125.777 (2.206 to 9.348)6.775 (3.105 to 10.446)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.362 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -1.779 · 95% CI -5.606 to 2.049An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.731 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.712 · 95% CI -4.783 to 3.359An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.911 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.236 · 95% CI -4.399 to 3.927An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.286 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -2.238 · 95% CI -6.359 to 1.882An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.483 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -1.590 · 95% CI -6.044 to 2.865An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.687 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.998 · 95% CI -5.859 to 3.863An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
SecondaryChange From Baseline to Entire Treatment Period in Percentage of COPD Symptom-Free Days

COPD symptom scores consists of following 6 items recorded by the participants in diary. * ability to perform the usual daily activities; * breathlessness over the previous 24h; * waking at night due to respiratory symptoms; * breathlessness on rising; * cough over the previous 24h; * sputum production over the previous 24h. Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst). A COPD symptom-free day is a day with total COPD symptom scores = 0. Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of COPD symptom-free days is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)\*100. % of COPD symptom-free days in each two-week period is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)\*100.

Time frame:
Baseline, Weeks 1 through 12
Reported as:
Mean · Percentage of days
Change From Baseline to Entire Treatment Period in Percentage of COPD Symptom-Free Days
Percentage of daysFoster®Seretide® Accuhaler®
Change From Baseline to Entire Treatment Period in Percentage of COPD Symptom-Free Days4.598 (1.786 to 7.411)5.876 (2.989 to 8.763)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · ANCOVA · p = 0.495 (Analysis was based on an ANCOVA model with change from baseline to entire treatment period as dependent variable, treatment and country as fixed effects and baseline (run-in period) as a covariate.) · Adjusted mean difference: -1.277 · 95% CI -4.958 to 2.403
SecondaryChange From Baseline to Each Two-Week Period in Average Use of Rescue Salbutamol Consumption

Number of rescue salbutamol puffs per day were recorded in the diary. Baseline use of rescue medication has been calculated as the mean number of puffs per day in the run-in period. Average use of rescue medication in each two-week period has been calculated as the mean number of puffs per day in each two week period. Adjusted means were reported.

Time frame:
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Reported as:
Mean · Number of puffs per day
Change From Baseline to Each Two-Week Period in Average Use of Rescue Salbutamol Consumption
Number of puffs per dayFoster®Seretide® Accuhaler®
Week 1-2-0.714 (-0.876 to -0.553)-0.507 (-0.671 to -0.344)
Week 3-4-0.621 (-0.788 to -0.454)-0.510 (-0.680 to -0.340)
Week 5-6-0.747 (-0.910 to -0.584)-0.664 (-0.830 to -0.498)
Week 7-8-0.683 (-0.858 to -0.508)-0.645 (-0.823 to -0.467)
Week 9-10-0.627 (-0.807 to -0.447)-0.659 (-0.843 to -0.476)
Week 11-12-0.599 (-0.778 to -0.419)-0.629 (-0.812 to -0.446)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.055 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.207 · 95% CI -0.418 to 0.004An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.322 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.111 · 95% CI -0.331 to 0.109An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.447 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.083 · 95% CI -0.296 to 0.131An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.748 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.038 · 95% CI -0.270 to 0.194An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.789 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: 0.033 · 95% CI -0.207 to 0.273An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.803 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: 0.030 · 95% CI -0.209 to 0.270An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
SecondaryChange From Baseline to Each Two-Week Period in Percentage of Rescue Salbutamol-Free Days

A rescue medication-free day is a day with number of puffs of rescue medication = 0. Reported values (in form of adjusted means) reflect a percentage (%). Baseline percentage (%) of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)\*100. % of rescue medication-free days in each two-week period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the two-week period)\*100.

Time frame:
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
Reported as:
Mean · Percentage of days
Change From Baseline to Each Two-Week Period in Percentage of Rescue Salbutamol-Free Days
Percentage of daysFoster®Seretide® Accuhaler®
Week 1-213.697 (9.356 to 18.038)11.341 (6.885 to 15.796)
Week 3-411.561 (7.035 to 16.087)10.473 (5.823 to 15.123)
Week 5-614.963 (10.233 to 19.693)15.313 (10.445 to 20.181)
Week 7-815.025 (10.200 to 19.851)14.519 (9.548 to 19.491)
Week 9-1013.368 (8.582 to 18.154)15.374 (10.436 to 20.312)
Week 11-1212.639 (7.713 to 17.566)14.573 (9.490 to 19.656)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.421 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: 2.356 · 95% CI -3.391 to 8.104An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.723 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: 1.088 · 95% CI -4.948 to 7.124An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.914 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -0.350 · 95% CI -6.693 to 5.993An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.878 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: 0.506 · 95% CI -5.985 to 6.997An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.540 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -2.006 · 95% CI -8.440 to 4.429An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
  • Foster® vs Seretide® Accuhaler® · Mixed Models Analysis · p = 0.568 (Linear MMRM with change from baseline to each two-week period as dependent variable, treatment, period, treatment x period interaction and country as fixed effects and baseline (run-in period) and baseline x period interaction as covariates.) · Adjusted mean difference: -1.934 · 95% CI -8.584 to 4.717An unstructured covariance matrix for each participant is considered and the Kenward-Roger adjustment is used for the degrees of freedom.
SecondaryChange From Baseline to Entire Treatment Period in Percentage of Rescue Salbutamol-Free Days

A rescue medication-free day is a day with number of puffs of rescue medication = 0. Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)\*100. % of rescue medication-free days in the entire treatment period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the entire treatment period)\*100.

Time frame:
at week 12 (V5)
Reported as:
Mean · Percentage of days
Change From Baseline to Entire Treatment Period in Percentage of Rescue Salbutamol-Free Days
Percentage of daysFoster®Seretide® Accuhaler®
Change From Baseline to Entire Treatment Period in Percentage of Rescue Salbutamol-Free Days13.501 (9.389 to 17.614)13.105 (8.889 to 17.322)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · ANCOVA · p = 0.885 (Analysis was based on an ANCOVA model with change from baseline to entire treatment period as dependent variable, treatment and country as fixed effects and baseline (run-in period) as a covariate.) · Adjusted mean difference: 0.396 · 95% CI -4.971 to 5.763
SecondaryChange From Baseline in the St George's Respiratory Questionnaire (SGRQ) Component and Total Scores

SGRQ is a 76-item questionnaire developed to measure health in chronic airflow limitation and designed to be self-completed by the participant. It consists of 76-items across three domains: * Symptoms, which evaluates the frequency and severity of respiratory issues like coughing, sputum production, and breathlessness; * Activity, which measures limitations in physical activities due to breathlessness; * Impacts, which examines psychological and social effects, including feelings of stigma, loss of control, and daily life disruption. Each domain score ranges from 0 to 100 with higher scores indicating the worst health status. Total score was obtained by combining the weighted scores from each domain and ranging from 0 (better health) to 100 (Worst health).

Time frame:
at Week 12 (V5)
Reported as:
Mean · Score on a scale
Change From Baseline in the St George's Respiratory Questionnaire (SGRQ) Component and Total Scores
Score on a scaleFoster®Seretide® Accuhaler®
SGRQ Total Score-5.915 (-7.749 to -4.081)-3.802 (-5.703 to -1.901)
SGRQ Symptom Score-8.017 (-10.795 to -5.240)-5.896 (-8.776 to -3.017)
SGRQ Activity Score-5.912 (-8.200 to -3.623)-3.512 (-5.841 to -1.183)
SGRQ Impacts Score-5.591 (-7.630 to -3.553)-3.854 (-5.982 to -1.727)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · ANCOVA · p = 0.080 (Analysis is based on an ANCOVA model with change from baseline as dependent variable, treatment and country as fixed effects and baseline as a covariate.) · Adjusted mean difference: -2.113 · 95% CI -4.480 to 0.253
  • Foster® vs Seretide® Accuhaler® · ANCOVA · p = 0.129 (Analysis is based on an ANCOVA model with change from baseline as dependent variable, treatment and country as fixed effects and baseline as a covariate.) · Adjusted mean difference: -3.694 · 95% CI -8.469 to 1.080
  • Foster® vs Seretide® Accuhaler® · ANCOVA · p = 0.108 (Analysis is based on an ANCOVA model with change from baseline as dependent variable, treatment and country as fixed effects and baseline as a covariate.) · Adjusted mean difference: -2.400 · 95% CI -5.333 to 0.533
  • Foster® vs Seretide® Accuhaler® · ANCOVA · p = 0.197 (Analysis is based on an ANCOVA model with change from baseline as dependent variable, treatment and country as fixed effects and baseline as a covariate.) · Adjusted mean difference: -1.737 · 95% CI -4.379 to 0.906
SecondaryChange From Baseline in Pre-dose and in Post-dose Distance Walked (6 Minute Walking Test - 6MWT)

The 6MWT was carried out following standardized procedures, according to ATS guidelines. The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test. Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes. The patients sit at rest for at least 10 minutes before the test start. The longer distance covered, the better the outcome.

Time frame:
Week 12 (V5), pre-dose and post-dose
Reported as:
Mean · Meters
Change From Baseline in Pre-dose and in Post-dose Distance Walked (6 Minute Walking Test - 6MWT)
MetersFoster®Seretide® Accuhaler®
Pre-dose31.619 (15.178 to 48.060)22.229 (6.298 to 38.159)
Post-dose46.469 (27.236 to 65.702)45.048 (26.306 to 63.791)
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · ANCOVA · p = 0.332 (Analysis is based on an ANCOVA model with change from baseline in pre-dose at Week 12 as dependent variable, treatment and country as fixed effects and baseline (pre-dose at Week 0) as a covariate.) · Adjusted mean difference: 9.390 · 95% CI -9.627 to 28.407
  • Foster® vs Seretide® Accuhaler® · ANCOVA · p = 0.900 (Analysis is based on an ANCOVA model with change from baseline in post-dose at Week 12 as dependent variable, treatment and country as fixed effects and baseline (pre-dose at Week 0) as a covariate.) · Adjusted mean difference: 1.421 · 95% CI -20.892 to 23.733
SecondaryChange From Pre-dose in Post-dose Distance Walked (6MWT)

The 6MWT was carried out following standardized procedures, according to ATS guidelines. The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test. Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes. The patients sit at rest for at least 10 minutes before the test start.

Time frame:
on Week 0 (Day 1, V2) and Week 12 (V5, Day 84)
Reported as:
Mean · Metres
Change From Pre-dose in Post-dose Distance Walked (6MWT)
MetresFoster®Seretide® Accuhaler®
From pre-dose to post-dose at Day 127.178 (16.936 to 37.419)28.273 (18.580 to 37.967)
From pre-dose to post-dose at Day 8412.989 (1.756 to 24.223)19.314 (8.399 to 30.229)
Statistical analysis
  • Foster® · ANCOVA · p = 0.853 (Analysis is based on an ANCOVA model with change from pre-dose in post-dose at Week 0 as dependent variable, treatment and country as fixed effects and baseline (pre-dose at Week 0) as a covariate.) · Adjusted mean difference: -1.096 · 95% CI -12.720 to 10.529
  • Foster® vs Seretide® Accuhaler® · ANCOVA · p = 0.340 (Analysis is based on an ANCOVA model with change from pre-dose in post-dose at Week 12 as dependent variable, treatment and country as fixed effects and baseline (pre-dose at Week 12) as a covariate.) · Adjusted mean difference: -6.325 · 95% CI -19.349 to 6.700
SecondaryNumber of Participants With COPD Exacerbations From Week 0 Through Week 12

A COPD exacerbation is defined as "a sustained worsening of the participants condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and requires unscheduled medical intervention \[leading to prescriptions of systemic corticosteroids (at least 3 days)\] and/or antibiotics (at least 5 days), or need for a visit to an emergency department or hospitalization) in a participant with underlying COPD".

Time frame:
Week 12
Reported as:
Number · Participants
Number of Participants With COPD Exacerbations From Week 0 Through Week 12
ParticipantsFoster®Seretide® Accuhaler®
Number of Participants With COPD Exacerbations From Week 0 Through Week 1264
Statistical analysis
  • Foster® vs Seretide® Accuhaler® · Fisher Exact · p = 0.751
SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs)

AE=An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine. Serious AE= An adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. ADR=A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility Serious ADR=An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. Severe AE= "Severe" refers to the intensity of an AE; the event itself may be of relatively minor medical significance but intense.

Time frame:
From first dose of study drug until end of the treatment (up to 84 days)
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
ParticipantsFoster®Seretide® Accuhaler®
Number of patients with TEAEs3646
Number of patients with ADRs62
Number of patients with serious TEAEs413
Number of patients with severe TEAEs25
Number of patients with TEAEs leading to study discontinuation35

Adverse events

Collected over AEs were collected from V1 (week -2, screening) through V5 (day 84, week 12, end of treatment) to follow-up (after 7-10 days of last study medication intake, i.e. day 91-94). AEs and overall mortality presented represent the safety set (i.e. all patients receiving any amount of study drug, including both run-ins and randomized patients). As per planned analysis, AEs were collected in a combined manner: i.e. data on the run-in phase were combined with the ones of the reported arms.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Run-in and Randomized Foster® (Safety Set)1/211 (0.5%)4/211 (1.9%)36/211 (17.1%)
Run-in and Seretide® Accuhaler® (Safety Set)0/208 (0%)13/208 (6.3%)46/208 (22.1%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventRun-in and Randomized Foster® (Safety Set)Run-in and Seretide® Accuhaler® (Safety Set)
PneumoniaInfections and infestations0/2113/208
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders0/2112/208
AnaemiaBlood and lymphatic system disorders0/2111/208
Cardiac failureCardiac disorders0/2111/208
VertigoEar and labyrinth disorders0/2111/208
AppendicitisInfections and infestations0/2111/208
DiverticulitisInfections and infestations0/2111/208
GastroenteritisInfections and infestations0/2111/208
Post procedural infectionInfections and infestations0/2111/208
Alcohol poisoningInjury, poisoning and procedural complications0/2111/208
Most frequent other events
Showing 10 of 87
Most frequent other events
EventRun-in and Randomized Foster® (Safety Set)Run-in and Seretide® Accuhaler® (Safety Set)
NasopharyngitisInfections and infestations7/2112/208
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders2/2115/208
PneumoniaInfections and infestations0/2114/208
HypertensionVascular disorders0/2113/208
RhinitisInfections and infestations3/2111/208
DiarrhoeaGastrointestinal disorders1/2112/208
BronchitisInfections and infestations0/2112/208
CystitisInfections and infestations0/2112/208
DiverticulitisInfections and infestations0/2112/208
HypercholesterolaemiaMetabolism and nutrition disorders0/2112/208

Baseline characteristics

Intention-to-Treat population (ITT): All randomized participants who received at least one administration of the study medication and with at least one available post-baseline efficacy data.

Age, Continuous
Age, Continuous(Years)Foster®Seretide® Accuhaler®Total
Mean63.8 ± 8.263.7 ± 8.663.75 ± 8.39
Sex: Female, Male
Sex: Female, Male(Participants)Foster®Seretide® Accuhaler®Total
Female5664120
Male155143298
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Foster®Seretide® Accuhaler®Total
Hispanic or Latino161632
Not Hispanic or Latino195191386
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Foster®Seretide® Accuhaler®Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American011
White211206417
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Foster®Seretide® Accuhaler®Total
Italy161733
Denmark161531
France022
Germany232245
Hungary8079159
Poland393978
Slovakia201737
Spain437
Turkey131225
United Kingdom011
Pre-dose FEV1
Pre-dose FEV1(Liters)Foster®Seretide® Accuhaler®Total
Mean1.131 ± 0.4011.101 ± 0.3601.116 ± 0.381
08

Study locations

68 sites
  • Aarhus University Hospital
    Aarhus, Denmark
  • Bispebjerg Hospital
    Copenhagen, Denmark
  • Dept. of Cardiology and Respiratory Medicine
    Copenhagen, Denmark
  • Gentofte Hospital
    Gentofte Municipality, Denmark
  • Odense University Hospital
    Odense, Denmark
  • Centre Hospitalier
    Toulon, France
  • Praxis Dr. Jorg Kampschulte
    Berlin, Germany
  • Praxis Dr. Jörg Winkler
    Leipzig, Germany
  • KLB Healthresearch
    Lübeck, Germany
  • KLD Helthreseach
    Lübeck, Germany
  • SMO.MD GmbH Zentrum für Klinische Studien
    Magdeburg, Germany
  • Pneumologische Gemeinschaftspraxis Saarbrücken
    Saarbrücken, Germany
  • Fachinternistische Gemeinschafts
    Wedel, Germany
  • Pneumologische Praxis Dr Redlich
    Wiesloch, Germany
  • Gemeinschaftspraxis für Pneumologie
    Wuppertal, Germany
  • Dr. Kenessey Albert Kórház - Rendelőintézet
    Balassagyarmat, Hungary
  • Békés Megyei Képviselő-testület Pándy Kálmán Kórház
    Békés, Hungary
  • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház
    Budapest, Hungary
  • Centrum-Tüdőgyógyászati Klinika
    Debrecen, Hungary
  • Bács-Kiskun Megeyi Önkormanyzat...
    Kecskemét, Hungary
  • Karolina Kórház és Rendelőintézet Tüdőgyógyászat
    Mosonmagyaróvár, Hungary
  • Békés Megyei Képviselő-testület Pándy Kálmán Kórház
    Nyíregyháza, Hungary
  • Jósa András Hospital
    Nyíregyháza, Hungary
  • Chiesi Clinical Centre Szigetszentmiklös
    Szigetszentmiklös, Hungary
  • Ospedale Sant'Orsola-Malpighi
    Bologna, Italy
  • A.O. Policlinico
    Catania, Italy
  • A.O. S. Gerardo
    Monza, Italy
  • Azienda Ospedaliera Monaldi
    Naples, Italy
  • Università di Pisa
    Pisa, Italy
  • IRCCS San Raffaele La Pisana
    Roma, Italy
  • Policlinico Umberto I - VIII Padiglione
    Rome, 00161, Italy
  • NZOZ "Non Nocere"
    Gdansk, Poland
  • Niepubliczny Zakład Opieki Zdrowotnej "PROFILAKTYKA"
    Koszalin, Poland
  • Szpital Specjalistyczny im Jana Pawła II
    Krakow, Poland
  • Szpital Uniwersytecki w Krakowie
    Krakow, Poland
  • Prywatny Gabinet Specjalistyczny
    Lodz, Poland
  • Samodzielny Publiczny Szpital Kliniczny
    Szczecin, Poland
  • Chorób Płuc
    Warsaw, Poland
  • Gabinet Lekarski SERIA IWONA GRZELEWSKA-RZYMOWSKA
    Warsaw, Poland
  • Instytut Gruźlicy i Chorób Płuc. Zakład Diagnostyki i Leczenia Niewydolności Oddychania
    Warsaw, Poland
  • Zakład Fizjopatologii Oddychania, Instytut Gruźlicy i Chorób Płuc
    Warsaw, Poland
  • DOBROSTAN - Gabinety Lekarskie
    Wroclaw, Poland
  • NZOZ Lekarze Specjaliści J.Małolepszy i Partnerzy
    Wroclaw, Poland
  • Wojewódzki Szpital Specjalistyczny im. M. Curie-Skłodowskiej)
    Zgierz, Poland
  • Neštátna ambulancia pneumológie a ftizeológie, Nemocničná
    Humenné, Slovakia
  • Diunea, sro. Ambulancia PaF
    Nové Zámky, Slovakia
  • ALERGOIMUNO s.r.o
    Ostrov, Slovakia
  • Pľúcna ambulancia, Poliklinika ADUS
    Poprad, Slovakia
  • PULMO, s.r.o
    Prešov, Slovakia
  • PNEUMO-MED, s.r.o
    Prievidza, Slovakia
  • Pľúcna ambulancia, Hrebenár s.r.o
    Spišská Nová Ves, Slovakia
  • PNEUMO-CENTRUM, s.r.o, Poliklinika
    Trnava, Slovakia
  • Hospital del Mar
    Barcelona, Spain
  • Hospital Parc Taulí
    Sabadell, Spain
  • Hospital General Vic
    Vic, Spain
  • Çukurova Üniversitesi
    Adana, Turkey (Türkiye)
  • Akdeniz Üniversitesi
    Antalya, Turkey (Türkiye)
  • Bilim Üniversitesi
    Antalya, Turkey (Türkiye)
  • Ege Universitesi
    Bornova, Turkey (Türkiye)
  • Uludag Üniversitesi
    Bursa, Turkey (Türkiye)
  • Gaziantep Üniversitesi
    Gaziantep, Turkey (Türkiye)
  • Fatih Üniversitesi
    Istanbul, Turkey (Türkiye)
  • Marmara Üniversitesi
    Istanbul, Turkey (Türkiye)
  • Dokuz Eylül Üniversitesi
    Izmir, Turkey (Türkiye)
  • Erciyes Üniversitesi
    Kayseri, Turkey (Türkiye)
  • Belfast City Hospital
    Belfast, United Kingdom
  • Kings College Hospital
    London, United Kingdom
  • Freeman Hospital
    Newcastle, United Kingdom
09

References and documents

Publications

  • Singh D, Nicolini G, Bindi E, Corradi M, Guastalla D, Kampschulte J, Pierzchala W, Sayiner A, Szilasi M, Terzano C, Vestbo J; FUTURE (Foster Upgrades TherapeUtic care in REspiratory disease) study group. Extrafine beclomethasone/formoterol compared to fluticasone/salmeterol combination therapy in COPD. BMC Pulm Med. 2014 Mar 12;14:43. doi: 10.1186/1471-2466-14-43. PubMed 24621109 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01245569
Lead sponsor
Chiesi Farmaceutici S.p.A.
Responsible party
Sponsor
First posted
Nov 22, 2010
Start date
Apr 12, 2011
Primary completion
Mar 13, 2012
Completion
Mar 13, 2012
Results posted
Aug 10, 2026
Last update
Aug 10, 2026

Study contacts

Dave Singh, MD
principal investigator · The Medicine Evaluation Unit - Manchester, UK
Jorgen Vestbo, MD
principal investigator · Dept. of Cardiology and Respiratory Medicine - Copenhagen, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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