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CompletedNCT03888131FORSYYNUpdated May 12, 2026Results posted

Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN)

A Phase 3 interventional study of CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo and Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo in Chronic Obstructive Pulmonary Disease, sponsored by Chiesi Farmaceutici S.p.A.. Completed at 53 sites in China. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.

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

Phase
Phase 3
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

Primary Objective

To demonstrate that CHF 1535 pMDI is non-inferior to Symbicort® Turbohaler® in terms of pulmonary function (change from baseline in pre-dose morning FEV1 at Week 24) in patients with COPD.

Secondary Objectives

  • To evaluate the effect of CHF 1535 pMDI on other lung function parameters, and patient reported outcomes (PROs);
  • To assess the safety and the tolerability of the study treatments.
Read the detailed description

This was a Phase III, multicenter, randomized, double-blind, double-dummy, active-controlled, 2-arm parallel-group study designed to evaluate the non-inferiority of CHF 1535 100/6 µg pMDI (400/24 µg/day) versus Symbicort® Turbohaler® 160/4.5 µg (640/18 µg/day) in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).

The study included the following phases:

  • Screening and Run-in Phase (Visit 1, Weeks -6 to 0): Patients underwent eligibility assessments, including spirometry and medical history review. Eligible participants entered a 6-week open-label run-in period with Symbicort® Turbohaler® 160/4.5 µg (640/18 µg/day) to establish baseline parameters and standardize therapy before randomization.
  • Randomization Phase (Visit 2, Week 0): Patients meeting eligibility criteria were randomized in a 1:1 ratio to receive either CHF 1535 100/6 µg pMDI (400/24 µg/day) or Symbicort® Turbohaler® 160/4.5 µg (640/18 µg/day) for 24 weeks. Randomization was performed via an Interactive Web Response System (IWRS) to ensure balanced treatment allocation.
  • Investigational Phase (Treatment Period: Weeks 0-24): Patients attended scheduled visits at Weeks 4, 12, 18, and 24 to assess treatment efficacy and safety. Daily assessments included pre-dose morning Peak Expiratory Flow (PEF), rescue medication use, and COPD symptom scores, recorded using an electronic diary. At each visit, lung function (FEV1, FVC, IC, and PEF), COPD symptom scores, and rescue medication use were evaluated. Vital signs (heart rate, blood pressure), adverse events (AEs), serious adverse events (SAEs), and laboratory assessments were monitored throughout the study.
  • Follow-Up Phase: A safety follow-up phone call was conducted 7-14 days after the final visit (Week 24) or early termination to assess any unresolved adverse events (AEs) or newly reported concomitant medications.

The total study duration per participant was 30 weeks, including the 6-week run-in period, 24-week treatment phase, and follow-up assessment.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • Lung functions
  • COPD
  • Symbicort Turbohaler
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 750 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

Inclusion criteria

Patients had to meet all of the following criteria to be eligible for enrolment into the study:

  1. Male and female adults aged ≥40 years, of Chinese ethnicity with written informed consent prior to any study-related procedure;
  2. Patients with a diagnosis of COPD (according to the GOLD document [1], updated 2017) at least 12 months before the screening visit;
  3. A smoking history of at least 10 pack-years [pack-years = (number of cigarettes per day x number of years)/20]. Current and ex-smokers were eligible; Note: Smoking cessation therapy had to be completed 6 months prior to screening visit;
  4. A post-bronchodilator FEV1 \<50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio \<0.7, 10 to 15 minutes after 4 puffs (4 x 100 µg) of salbutamol pMDI; Note: If this criterion was not met at screening, the test could be repeated no more than 7 days before the randomisation visit;
  5. A documented history of at least one exacerbation in the 12 months preceding the screening visit. COPD exacerbation was defined according to the following: "A sustained worsening of the patient's 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 necessitates a change in regular medication in a patient with underlying COPD that includes prescriptions of systemic corticosteroids and/or antibiotics or need for hospitalisation";

  6. Patients in treatment for at least 2 months prior to screening with either:

    • ICS/LABA; or
    • ICS/LAMA; or
    • Inhaled LABA and inhaled LAMA; or
    • LAMA; or
    • LABA; Note: Triple therapy was not allowed 2 months before the screening visit;
  7. A cooperative attitude and ability to be trained to use correctly the study treatment inhalers (pMDI and Turbohaler®);
  8. A cooperative attitude and ability to be trained to use correctly the COPD questionnaires.

Exclusion criteria

Exclusion Criteria:

  1. Patients requiring use of the following medications:

    • Systemic steroids for COPD exacerbation in the 4 weeks prior to screening;
    • A course of antibiotics for COPD exacerbation longer than 7 days in the 4 weeks prior to screening;
    • Phosphodiesterase (PDE) inhibitors in the 4 weeks prior to screening;
    • Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) in the 4 weeks prior to screening;
  2. COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period;
  3. Changes in dose, schedule, formulation or product of oral xanthine derivatives (e.g. theophylline) in the month prior to the screening visit or during the run-in period. Stop of xanthines prior to the screening visit was allowed;
  4. Known respiratory disorders other than COPD which may have impacted the efficacy of the study treatment according to the Investigator's judgement. This could have included, but was not limited to, α-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease;
  5. Diagnosis of asthma, history of allergic rhinitis or atopy (atopy which may have risen contra-indications or impacted the efficacy of the study according to the Investigator's judgement);
  6. Patients treated with long-acting antihistamines (e.g. astemizole, terfenadine) unless taken at stable regimen at least 2 months prior to screening and maintained constant during the study, or if taken as required (PRN);
  7. Patients requiring long-term (at least 12 hours daily) oxygen therapy for chronic hypoxemia;
  8. History of hypersensitivity to β2-agonists, corticosteroids or any of the excipients contained in any of the formulations used in the study;
  9. Patients treated with non-cardioselective β-blockers in the 4 weeks preceding the screening visit or during the run-in period;
  10. Patients who had a clinically significant (CS) active cardiovascular condition (such as, but not limited to, unstable ischemic heart disease, New York Heart Association [NYHA] Class III/IV, left ventricular failure, acute myocardial infarction, advanced atrio-ventricular conduction blocks);

  11. Patients with atrial fibrillation:

    • Paroxysmal (i.e. intermittent);
    • Persistent as defined by continuous atrial fibrillation diagnosed for less than 6 months;
    • Persistent for at least 6 months with a resting ventricular rate ≥100/minute controlled with a rate control strategy (i.e. selective β-blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy);
  12. An abnormal and CS 12-lead ECG that resulted in an active medical problem which may have impacted the safety of the patient or showed Fridericia-corrected QT interval (QTcF) >450 ms for males or QTcF >470 ms for females;
  13. Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; uncontrolled gastrointestinal disease (e.g. active peptic ulcer); neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, significant hepatic impairment, significant renal impairment or other which may impact the feasibility of the results of the study according to the Investigator's judgment;
  14. CS laboratory abnormalities indicating a significant or unstable concomitant disease which may have impacted the efficacy or the safety of the study treatment according to the Investigator's judgment;
  15. Patients with serum potassium levels \<3.5 mEq/L (or 3.5 mmol/L);
  16. History of alcohol abuse and/or substance/drug abuse within 12 months prior to the screening visit;

  17. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they were using one or more of the following highly effective contraceptive measures:

    • Placement of an intrauterine device or intrauterine hormone-releasing system;
    • Combined (oestrogen and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal);
    • Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);
    • Bilateral tubal occlusion;
    • Vasectomised partner; Reliable contraception had to be maintained throughout the study; Any postmenopausal women (physiologic menopause defined as "12 consecutive months of amenorrhea without an alternative medical cause") or women permanently sterilised (e.g. bilateral oophorectomy, hysterectomy or bilateral salpingectomy) could be enrolled in the study; Pregnancy tests were performed at study entry (a serum test at the screening visit and a urine test at screening and randomisation visits) in all women of childbearing potential;
  18. Participation in an interventional clinical trial with intake of the last dose of any investigational drug \<12 weeks preceding baseline visit (last dose \<5 half-lives prior to baseline visit for biologics).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
750 participants (actual)

Study arms

  • Experimental
    CHF 1535 100/6 µg pMDI

    The experimental arm included 377 patients who received CHF 1535, a fixed-dose combination of beclometasone dipropionate (100 µg) and formoterol fumarate (6 µg). The treatment was administered as two inhalations twice daily (b.i.d.) via a pressurized metered-dose inhaler (pMDI), resulting in a total daily dose of 400 µg of beclometasone dipropionate and 24 µg of formoterol fumarate. During the initial 4-week run-in phase, patients in this group were treated with Symbicort® Turbohaler® 160/4.5 µg, administered as two inhalations b.i.d., to stabilize their clinical condition. After this period, patients transitioned to the randomized treatment phase, where they received CHF 1535 for 24 weeks. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d.

    Drug: CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo

  • Active comparator
    Symbicort® Turbohaler®

    The active comparator arm involved 373 patients treated with Symbicort® Turbohaler®, a fixed-dose combination of budesonide (160 µg) and formoterol fumarate (4.5 µg). Treatment in this group also involved two inhalations b.i.d., administered via a dry powder inhaler (Turbohaler®), providing a total daily dose of 640 µg of budesonide and 18 µg of formoterol fumarate. Similar to the experimental arm, these patients underwent a 4-week run-in phase with Symbicort® Turbohaler® 160/4.5 µg, followed by 24 weeks of randomized treatment with the same drug. To ensure blinding, the study employed a double-dummy design. Patients in the CHF 1535 group were also given a placebo Turbohaler®, while those in the Symbicort® group received a placebo pMDI, with both placebos administered as two inhalations b.i.d.

    Drug: Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo

Interventions

  • DrugCHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo

    2 inhalations BID Total Daily Dose = 400/24µg

    Also known as: Foster®, Beclometasone Dipropionate/Formoterol Fumarate (BDP/FF)

  • DrugSymbicort® Turbohaler® plus CHF 1535 pMDI Placebo

    2 inhalations BID Total Daily Dose = 640/18µg

    Also known as: Budesonide/Formoterol Fumarate (BUD/FF)

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Pre-dose Morning First Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

    Forced Expiratory Volume in 1 second (FEV1) measures lung function by quantifying the volume of air forcefully exhaled during the first second of a forced expiratory maneuver. Spirometry was conducted at baseline and Week 24 to assess treatment effects in patients with moderate-to-severe COPD. Baseline FEV1, recorded during the run-in phase before randomization, was used as the reference for changes post-treatment. Tests were performed under controlled conditions using calibrated equipment. Patients inhaled deeply to full capacity and exhaled forcefully into the spirometer. Each completed at least three acceptable maneuvers, with the highest value recorded for analysis. FEV1 higher values indicate better lung function. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction, making it a key parameter in COPD management.

    Time frame: Baseline and week 24

Secondary outcomes

  1. Change From Baseline in Pre-dose Morning FEV1 at All the Other Clinic Visits in Patients With Chronic Obstructive Pulmonary Disease (COPD)

    Forced Expiratory Volume in 1 second (FEV1) is a key measure of lung function that quantifies the volume of air a patient can exhale forcefully in the first second of a forced expiratory maneuver. Spirometry was conducted at baseline and at Weeks 4, 12, 18, and 24 to evaluate treatment effects in patients with moderate-to-severe COPD. Baseline FEV1, recorded during the run-in phase before randomization, served as a reference for post-treatment changes. Tests were performed under controlled conditions with calibrated equipment. Patients were seated, instructed to inhale deeply to full capacity, and exhale forcefully into the spirometer. At least three acceptable and repeatable maneuvers were completed, and the highest value was used for analysis. FEV1 is measured in liters (L), with higher values indicating better lung function. Increases in FEV1 reflect improved airway patency and reduced obstruction, while decreases indicate worsening airflow limitation.

    Time frame: Baseline and week 4, week 12, week 18

  2. Change From Baseline in Pre-dose Morning Force Vital Capacity (FVC) at All Timepoints

    Forced Vital Capacity (FVC) measures the total volume of air a patient can exhale forcefully after a full inhalation, offering key insights into lung function. Baseline FVC, recorded during the run-in phase before randomization, served as a reference for evaluating changes during treatment. Spirometry tests were conducted in controlled settings with calibrated, high-precision equipment to ensure accuracy and reliability. Patients performed the test while seated, inhaling deeply to full lung capacity and exhaling forcefully and completely into the spirometer. At least three acceptable maneuvers meeting predefined criteria for consistency were required, with the highest FVC value recorded for analysis. The procedure adhered to standardized protocols, including calibration of equipment before each test, coaching by trained technicians, and monitoring for quality control. FVC is measured in liters (L); higher values indicate improved lung capacity and reduced airway obstruction.

    Time frame: Baseline and week 4, week 12, week 18 and week 24

  3. Change From Baseline in Pre-dose Morning Inspiratory Capacity (IC) at All Timepoints

    Inspiratory Capacity (IC) measures the maximum volume of air a patient can inhale after a normal exhalation, providing key insights into lung expansion and respiratory mechanics. Baseline IC, recorded during the run-in phase before randomization, was used as a reference for treatment-related changes. Spirometry tests were performed in controlled conditions using calibrated, high-precision equipment to ensure accuracy. Patients exhaled to their functional residual capacity, then inhaled deeply into the spirometer. At least three acceptable maneuvers were completed, and the highest IC value was recorded. The procedure followed standardized protocols, including pre-test calibration, technician coaching, and quality control monitoring. IC is measured in liters (L), with higher values indicating improved lung capacity, reduced restriction, and enhanced respiratory function.

    Time frame: Baseline and week 4, week 12, week 18 and week 24

  4. Change From Baseline in Pre-dose Maximal Mid-expiratory Flow (MMEF) at All Timepoints

    Maximal Mid-Expiratory Flow (MMEF) measured the mean expiratory flow during the middle 50% of a forced vital capacity (FVC) maneuver, reflecting airflow through small airways. It was an important indicator of small airway function, often impaired in diseases like COPD. MMEF was measured using spirometry under standardized conditions with calibrated equipment. Patients inhaled deeply to full lung capacity and exhaled forcefully into the spirometer. The highest value from at least three acceptable maneuvers was recorded. MMEF was expressed in liters per second (L/sec), with lower values indicating increased resistance in small airways, a hallmark of COPD and asthma. The parameter was particularly sensitive to detecting early changes in small airway function that may not yet be apparent in larger airway measurements like FEV1 or FVC. This sensitivity made MMEF valuable for assessing treatment efficacy and progression in diseases affecting small airway mechanics.

    Time frame: Baseline and week 4, week 12, week 18 and week 24

  5. Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score and Domain Scores at Week 12 and Week 24

    The SGRQ is a validated tool used to assess health-related quality of life in patients with chronic respiratory diseases. It consists of 76 items across 3 domains: * Symptoms (0-100; the lower the score, the better the heath), evaluating frequency and severity of respiratory issues (coughing, sputum production, breathlessness etc); * Activity (0-100; idem), measuring limitations in physical activities due to breathlessness; * Impacts (0-100; idem), examining psychological \& social effects (feelings of stigma, loss of control, and daily life disruption etc). Each domain score = sum of the weights of the positive items of that domain / sum of the weights of all items of that domain)\*100. Total score (0 - 100) is calculated by combining the weighted scores from each domain, with higher scores indicating a greater burden of disease and poorer quality of life. A reduction of 4 points or more in the total score is considered clinically significant.

    Time frame: Baseline, week 12, week 24

  6. Change From Baseline in COPD Assessment Test (CAT)

    The COPD Assessment Test (CAT) is a validated eight-item questionnaire designed to assess the impact of Chronic Obstructive Pulmonary Disease (COPD) on a patient's health status. It evaluates symptoms and quality of life, including cough, phlegm production, chest tightness, breathlessness during physical activity, sleep quality, and energy levels. Each item is scored from 0 (no impact) to 5 (severe impact), resulting in a total score range of 0 to 40, where higher scores indicate a greater disease burden and worse health status. The CAT was completed at baseline and during scheduled clinic visits throughout the treatment period. Scores were calculated by summing the responses to all eight items. A reduction in the CAT score reflects improvement in the patient's condition, with a change of 2 points or more considered clinically significant. This outcome captures changes in the patient's quality of life and provides a direct measure of the perceived impact of COPD on daily living.

    Time frame: At week 4, week 12, week 18 and week 24

  7. Rate of Moderate and Severe COPD Exacerbations Over 24 Weeks of Treatment. - Moderate Exacerbations Require Treatment With Systemic Corticosteroids and/or Antibiotics - Severe Exacerbations Require Hospitalisation or Result in Death

    This outcome measures the frequency of moderate and severe exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during the treatment period. A moderate exacerbation is defined as a worsening of respiratory symptoms requiring treatment with systemic corticosteroids, antibiotics, or both, without hospitalization. A severe exacerbation is defined as a worsening of symptoms requiring hospitalization or resulting in death. Exacerbations were recorded from the start of treatment to the final scheduled visit, using data from patient-reported symptom diaries, healthcare provider assessments, and verified medical records.

    Time frame: Over 24 weeks of treatment

  8. Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". A SAE is defined as any untoward medical occurrence or effect that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

    Time frame: Over 29 weeks (from Visit 0 to Visit 6)

07

Results

Posted May 12, 2026

Participant flow

Recruitment occurred across 50 centers in China, where 1,182 patients were screened, and 750 were randomized to CHF 1535 (377) or Symbicort® (373). Pre-screening evaluated eligibility, followed by screening with medical history review, spirometry, and inclusion/exclusion criteria confirmation. Eligible patients entered a 6-week run-in phase with open-label Symbicort® Turbohaler® to standardize therapy before randomization

Participant flow — Overall Study
MilestoneCHF 1535 100/6 µg pMDI - ITT PopulationSymbicort® Turbohaler® - ITT Population
Started377373
Safety population (saf)377373
Intention-to-treat population (itt)376373
Per protocol population (pp)361358
Completed335322
Not completed4251
Withdrew: Withdrawal by subject68
Withdrew: Restrictions related to the covid-19 outbreak2524
Withdrew: Adverse event512
Withdrew: Lack of efficacy24
Withdrew: Death23
Withdrew: Lost to follow-up20

Outcome measures

PrimaryChange From Baseline in Pre-dose Morning First Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Forced Expiratory Volume in 1 second (FEV1) measures lung function by quantifying the volume of air forcefully exhaled during the first second of a forced expiratory maneuver. Spirometry was conducted at baseline and Week 24 to assess treatment effects in patients with moderate-to-severe COPD. Baseline FEV1, recorded during the run-in phase before randomization, was used as the reference for changes post-treatment. Tests were performed under controlled conditions using calibrated equipment. Patients inhaled deeply to full capacity and exhaled forcefully into the spirometer. Each completed at least three acceptable maneuvers, with the highest value recorded for analysis. FEV1 higher values indicate better lung function. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction, making it a key parameter in COPD management.

Time frame:
Baseline and week 24
Reported as:
Mean · liters
Change From Baseline in Pre-dose Morning First Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
litersCHF 1535 100/6 µg pMDI - ITT PopulationSymbicort® Turbohaler® - ITT Population
Change From Baseline in Pre-dose Morning First Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Obstructive Pulmonary Disease (COPD)-0.020 (-0.036 to -0.004)-0.019 (-0.035 to -0.002)
Statistical analysis
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = <0.001 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: -0.001 · 95% CI -0.025 to 0.022An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom
SecondaryChange From Baseline in Pre-dose Morning FEV1 at All the Other Clinic Visits in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Forced Expiratory Volume in 1 second (FEV1) is a key measure of lung function that quantifies the volume of air a patient can exhale forcefully in the first second of a forced expiratory maneuver. Spirometry was conducted at baseline and at Weeks 4, 12, 18, and 24 to evaluate treatment effects in patients with moderate-to-severe COPD. Baseline FEV1, recorded during the run-in phase before randomization, served as a reference for post-treatment changes. Tests were performed under controlled conditions with calibrated equipment. Patients were seated, instructed to inhale deeply to full capacity, and exhale forcefully into the spirometer. At least three acceptable and repeatable maneuvers were completed, and the highest value was used for analysis. FEV1 is measured in liters (L), with higher values indicating better lung function. Increases in FEV1 reflect improved airway patency and reduced obstruction, while decreases indicate worsening airflow limitation.

Time frame:
Baseline and week 4, week 12, week 18
Reported as:
Mean · liters
Change From Baseline in Pre-dose Morning FEV1 at All the Other Clinic Visits in Patients With Chronic Obstructive Pulmonary Disease (COPD)
litersCHF 1535 100/6 µg pMDI - ITT PopulationSymbicort® Turbohaler® - ITT Population
V3 (Week 4) pre-dose morning FEV1 (L)-0.005 (-0.018 to 0.008)-0.006 (-0.019 to 0.007)
V4 (Week 12) pre-dose morning FEV1 (L)-0.014 (-0.028 to -0.001)-0.015 (-0.029 to -0.001)
V5 (Week 18) pre-dose morning FEV1 (L)-0.007 (-0.022 to 0.009)-0.014 (-0.029 to 0.002)
Statistical analysis
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.887 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.001 · 95% CI -0.017 to 0.020An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.938 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.001 · 95% CI -0.019 to 0.020An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.544 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.007 · 95% CI -0.015 to 0.029An unstructured covariance matrix was assumed and the Kenward-Roger adjustment was used for the degrees of freedom
SecondaryChange From Baseline in Pre-dose Morning Force Vital Capacity (FVC) at All Timepoints

Forced Vital Capacity (FVC) measures the total volume of air a patient can exhale forcefully after a full inhalation, offering key insights into lung function. Baseline FVC, recorded during the run-in phase before randomization, served as a reference for evaluating changes during treatment. Spirometry tests were conducted in controlled settings with calibrated, high-precision equipment to ensure accuracy and reliability. Patients performed the test while seated, inhaling deeply to full lung capacity and exhaling forcefully and completely into the spirometer. At least three acceptable maneuvers meeting predefined criteria for consistency were required, with the highest FVC value recorded for analysis. The procedure adhered to standardized protocols, including calibration of equipment before each test, coaching by trained technicians, and monitoring for quality control. FVC is measured in liters (L); higher values indicate improved lung capacity and reduced airway obstruction.

Time frame:
Baseline and week 4, week 12, week 18 and week 24
Reported as:
Mean · liters
Change From Baseline in Pre-dose Morning Force Vital Capacity (FVC) at All Timepoints
litersCHF 1535 100/6 µg pMDI - ITT PopulationSymbicort® Turbohaler® - ITT Population
V3 (Week 4) pre-dose morning FVC (L)0.001 (-0.033 to 0.035)-0.024 (-0.058 to 0.009)
V4 (Week 12) pre-dose morning FVC (L)-0.013 (-0.050 to 0.025)-0.057 (-0.095 to -0.019)
V5 (Week 18) pre-dose morning FVC (L)0.012 (-0.027 to 0.051)-0.017 (-0.057 to 0.022)
V6 (Week 24) pre-dose morning FVC (L)0.012 (-0.030 to 0.053)-0.024 (-0.066 to 0.018)
Statistical analysis
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.297 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.026 · 95% CI -0.022 to 0.073
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.102 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.044 · 95% CI -0.009 to 0.098
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.296 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.029 · 95% CI -0.026 to 0.085
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.242 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.035 · 95% CI -0.024 to 0.095
SecondaryChange From Baseline in Pre-dose Morning Inspiratory Capacity (IC) at All Timepoints

Inspiratory Capacity (IC) measures the maximum volume of air a patient can inhale after a normal exhalation, providing key insights into lung expansion and respiratory mechanics. Baseline IC, recorded during the run-in phase before randomization, was used as a reference for treatment-related changes. Spirometry tests were performed in controlled conditions using calibrated, high-precision equipment to ensure accuracy. Patients exhaled to their functional residual capacity, then inhaled deeply into the spirometer. At least three acceptable maneuvers were completed, and the highest IC value was recorded. The procedure followed standardized protocols, including pre-test calibration, technician coaching, and quality control monitoring. IC is measured in liters (L), with higher values indicating improved lung capacity, reduced restriction, and enhanced respiratory function.

Time frame:
Baseline and week 4, week 12, week 18 and week 24
Reported as:
Mean · liters
Change From Baseline in Pre-dose Morning Inspiratory Capacity (IC) at All Timepoints
litersCHF 1535 100/6 µg pMDI - ITT PopulationSymbicort® Turbohaler® - ITT Population
V3 (Week 4) pre-dose morning IC (L)-0.004 (-0.033 to 0.026)0.012 (-0.018 to 0.042)
V4 (Week 12) pre-dose morning IC (L)-0.009 (-0.043 to 0.025)0.011 (-0.023 to 0.045)
V5 (Week 18) pre-dose morning IC (L)-0.015 (-0.046 to 0.017)0.019 (-0.013 to 0.051)
V6 (Week 24) pre-dose morning IC (L)-0.007 (-0.039 to 0.026)0.007 (-0.026 to 0.040)
Statistical analysis
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.471 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: -0.016 · 95% CI -0.058 to 0.027
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.415 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: -0.020 · 95% CI -0.068 to 0.028
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.143 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: -0.034 · 95% CI -0.079 to 0.011
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.556 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean change: -0.014 · 95% CI -0.060 to 0.032
SecondaryChange From Baseline in Pre-dose Maximal Mid-expiratory Flow (MMEF) at All Timepoints

Maximal Mid-Expiratory Flow (MMEF) measured the mean expiratory flow during the middle 50% of a forced vital capacity (FVC) maneuver, reflecting airflow through small airways. It was an important indicator of small airway function, often impaired in diseases like COPD. MMEF was measured using spirometry under standardized conditions with calibrated equipment. Patients inhaled deeply to full lung capacity and exhaled forcefully into the spirometer. The highest value from at least three acceptable maneuvers was recorded. MMEF was expressed in liters per second (L/sec), with lower values indicating increased resistance in small airways, a hallmark of COPD and asthma. The parameter was particularly sensitive to detecting early changes in small airway function that may not yet be apparent in larger airway measurements like FEV1 or FVC. This sensitivity made MMEF valuable for assessing treatment efficacy and progression in diseases affecting small airway mechanics.

Time frame:
Baseline and week 4, week 12, week 18 and week 24
Reported as:
Mean · L/sec
Change From Baseline in Pre-dose Maximal Mid-expiratory Flow (MMEF) at All Timepoints
L/secCHF 1535 100/6 µg pMDI - ITT PopulationSymbicort® Turbohaler® - ITT Population
V3 (Week 4) pre-dose MMEF (L/sec)-0.004 (-0.013 to 0.006)-0.004 (-0.014 to 0.006)
V4 (Week 12) pre-dose MMEF (L/sec)-0.007 (-0.015 to 0.000)0.002 (-0.006 to 0.010)
V5 (Week 18) pre-dose MMEF (L/sec)-0.006 (-0.015 to 0.002)-0.007 (-0.016 to 0.001)
V6 (Week 24) pre-dose MMEF (L/sec)-0.006 (-0.017 to 0.005)-0.008 (-0.019 to 0.003)
Statistical analysis
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.989 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.000 · 95% CI -0.014 to 0.014
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.112 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: -0.009 · 95% CI -0.020 to 0.002
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.874 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.001 · 95% CI -0.011 to 0.013
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.791 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.002 · 95% CI -0.013 to 0.018
SecondaryChange From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score and Domain Scores at Week 12 and Week 24

The SGRQ is a validated tool used to assess health-related quality of life in patients with chronic respiratory diseases. It consists of 76 items across 3 domains: * Symptoms (0-100; the lower the score, the better the heath), evaluating frequency and severity of respiratory issues (coughing, sputum production, breathlessness etc); * Activity (0-100; idem), measuring limitations in physical activities due to breathlessness; * Impacts (0-100; idem), examining psychological \& social effects (feelings of stigma, loss of control, and daily life disruption etc). Each domain score = sum of the weights of the positive items of that domain / sum of the weights of all items of that domain)\*100. Total score (0 - 100) is calculated by combining the weighted scores from each domain, with higher scores indicating a greater burden of disease and poorer quality of life. A reduction of 4 points or more in the total score is considered clinically significant.

Time frame:
Baseline, week 12, week 24
Reported as:
Mean · score on a scale
Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score and Domain Scores at Week 12 and Week 24
score on a scaleCHF 1535 100/6 µg pMDI - ITT PopulationSymbicort® Turbohaler® - ITT Population
SGRQ total score V4 (Week 12)-1.62 (-2.78 to -0.45)-1.39 (-2.56 to -0.21)
SGRQ total score V6 (Week 24)-1.62 (-3.00 to -0.24)-1.68 (-3.09 to -0.28)
SGRQ Symptoms score V4 (Week 12)-2.82 (-4.59 to -1.04)-2.01 (-3.80 to -0.22)
SGRQ Symptoms score V6 (Week 24)-4.02 (-5.91 to -2.12)-2.94 (-4.86 to -1.02)
SGRQ Impacts score V4 (Week 12)-1.64 (-3.05 to -0.22)-1.23 (-2.66 to 0.20)
SGRQ Impacts score V6 (Week 24)-1.34 (-2.99 to 0.31)-1.71 (-3.38 to -0.03)
SGRQ Activity score V4 (Week 12)-1.08 (-2.40 to 0.24)-1.43 (-2.77 to -0.09)
SGRQ Activity score V6 (Week 24)-1.24 (-2.72 to 0.24)-1.07 (-2.58 to 0.44)
Statistical analysis
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.785 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: -0.23 · 95% CI -1.89 to 1.43
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.949 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.06 · 95% CI -1.91 to 2.04
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.530 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: -0.81 · 95% CI -3.33 to 1.72
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.435 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: -1.07 · 95% CI -3.77 to 1.62
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.689 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: -0.41 · 95% CI -2.42 to 1.60
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.763 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.36 · 95% CI -1.99 to 2.72
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.711 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.36 · 95% CI -1.53 to 2.24
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.872 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: -0.17 · 95% CI -2.29 to 1.94
SecondaryChange From Baseline in COPD Assessment Test (CAT)

The COPD Assessment Test (CAT) is a validated eight-item questionnaire designed to assess the impact of Chronic Obstructive Pulmonary Disease (COPD) on a patient's health status. It evaluates symptoms and quality of life, including cough, phlegm production, chest tightness, breathlessness during physical activity, sleep quality, and energy levels. Each item is scored from 0 (no impact) to 5 (severe impact), resulting in a total score range of 0 to 40, where higher scores indicate a greater disease burden and worse health status. The CAT was completed at baseline and during scheduled clinic visits throughout the treatment period. Scores were calculated by summing the responses to all eight items. A reduction in the CAT score reflects improvement in the patient's condition, with a change of 2 points or more considered clinically significant. This outcome captures changes in the patient's quality of life and provides a direct measure of the perceived impact of COPD on daily living.

Time frame:
At week 4, week 12, week 18 and week 24
Reported as:
Mean · score on a scale
Change From Baseline in COPD Assessment Test (CAT)
score on a scaleCHF 1535 100/6 µg pMDI - ITT PopulationSymbicort® Turbohaler® - ITT Population
V3 (Week 4)0.0 (-0.4 to 0.5)-0.2 (-0.7 to 0.3)
V4 (Week 12)-0.1 (-0.6 to 0.5)0.0 (-0.5 to 0.6)
V5 (Week 18)0.2 (-0.4 to 0.8)0.0 (-0.5 to 0.6)
V6 (Week 24)-0.0 (-0.6 to 0.5)0.1 (-0.5 to 0.7)
Statistical analysis
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.514 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.2 · 95% CI -0.4 to 0.9
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.779 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: -0.1 · 95% CI -0.9 to 0.7
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.690 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: 0.2 · 95% CI -0.6 to 1.0
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Mixed Models Analysis · p = 0.759 (A linear MMRM included treatment, visit, treatment-by-visit interaction, region, prior year COPD exacerbations, airflow limitation severity, and smoking status as fixed effects, with baseline value and baseline-by-visit interaction as covariates) · Adjusted mean difference: -0.1 · 95% CI -0.9 to 0.7
SecondaryRate of Moderate and Severe COPD Exacerbations Over 24 Weeks of Treatment. - Moderate Exacerbations Require Treatment With Systemic Corticosteroids and/or Antibiotics - Severe Exacerbations Require Hospitalisation or Result in Death

This outcome measures the frequency of moderate and severe exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during the treatment period. A moderate exacerbation is defined as a worsening of respiratory symptoms requiring treatment with systemic corticosteroids, antibiotics, or both, without hospitalization. A severe exacerbation is defined as a worsening of symptoms requiring hospitalization or resulting in death. Exacerbations were recorded from the start of treatment to the final scheduled visit, using data from patient-reported symptom diaries, healthcare provider assessments, and verified medical records.

Time frame:
Over 24 weeks of treatment
Reported as:
Number · Exacerbation per year
Rate of Moderate and Severe COPD Exacerbations Over 24 Weeks of Treatment. - Moderate Exacerbations Require Treatment With Systemic Corticosteroids and/or Antibiotics - Severe Exacerbations Require Hospitalisation or Result in Death
Exacerbation per yearCHF 1535 100/6 µg pMDI - ITT PopulationSymbicort® Turbohaler® - ITT Population
Rate of Moderate and Severe COPD Exacerbations Over 24 Weeks of Treatment. - Moderate Exacerbations Require Treatment With Systemic Corticosteroids and/or Antibiotics - Severe Exacerbations Require Hospitalisation or Result in Death0.474 (0.375 to 0.600)0.547 (0.438 to 0.684)
Statistical analysis
  • CHF 1535 100/6 µg pMDI - ITT Population vs Symbicort® Turbohaler® - ITT Population · Negative Binomial Model · p = 0.372 · Adjusted rate ratio: 0.866 · 95% CI 0.632 to 1.187
SecondaryNumber of Patients With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment". A SAE is defined as any untoward medical occurrence or effect that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

Time frame:
Over 29 weeks (from Visit 0 to Visit 6)
Reported as:
Count of participants · Participants
Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
ParticipantsCHF 1535 100/6 µg pMDI - SAF PopulationSymbicort® Turbohaler® - SAF Population
Treatment Emergent Advers Events - TEAEs195191
Serious TEAEs4547
Adverse Drug Reaction - ADRs1517
Serious ADRs01
Severe TEAEs3127
TEAEs leading to discontinuation of study treatment514
TEAEs leading to death02

Adverse events

Collected over Adverse events (AEs) were recorded throughout the study, from screening (Day -42), to the end of treatment (Week 24), and up to the final follow-up visit at Week 26±2 weeks. AEs and overall mortality presented here 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 CHF 1535 100/6 µg pMDI (SAF Population)2/377 (0.5%)45/377 (11.9%)179/377 (47.5%)
Run-in and Randomized Symbicort® Turbohaler® (SAF Population)3/373 (0.8%)47/373 (12.6%)172/373 (46.1%)
Most frequent serious events
Showing 10 of 43
Most frequent serious events
EventRun-in and Randomized CHF 1535 100/6 µg pMDI (SAF Population)Run-in and Randomized Symbicort® Turbohaler® (SAF Population)
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders35/37731/373
PneumoniaInfections and infestations3/3774/373
Arteriosclerosis coronary arteryCardiac disorders0/3772/373
Respiratory failureRespiratory, thoracic and mediastinal disorders1/3772/373
Lower respiratory tract infectionInfections and infestations2/3770/373
PneumothoraxRespiratory, thoracic and mediastinal disorders2/3770/373
Atrioventricular block completeCardiac disorders0/3771/373
Cor pulmonale chronicCardiac disorders0/3771/373
Myocardial infarctionCardiac disorders0/3771/373
Inguinal herniaGastrointestinal disorders1/3771/373
Most frequent other events
Showing 10 of 241
Most frequent other events
EventRun-in and Randomized CHF 1535 100/6 µg pMDI (SAF Population)Run-in and Randomized Symbicort® Turbohaler® (SAF Population)
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders57/37755/373
Upper respiratory tract infectionInfections and infestations37/37742/373
NasopharyngitisInfections and infestations11/37716/373
HypertensionVascular disorders7/3779/373
Blood glucose increasedInvestigations5/3778/373
Ventricular extrasystolesCardiac disorders7/3774/373
ToothacheGastrointestinal disorders3/3776/373
Hepatic function abnormalHepatobiliary disorders1/3776/373
HypokalaemiaMetabolism and nutrition disorders5/3776/373
PneumoniaInfections and infestations6/3773/373

Baseline characteristics

Intention-to-Treat (ITT) population all randomised patients who received at least one administration of the study treatment and with at least one available evaluation of efficacy after baseline.

Age, Continuous
Age, Continuous(years)CHF 1535 100/6 µg pMDI - ITT PopulationSymbicort® Turbohaler® - ITT PopulationTotal
Mean65.6 ± 7.065.7 ± 6.665.6 ± 6.8
Sex: Female, Male
Sex: Female, Male(Participants)CHF 1535 100/6 µg pMDI - ITT PopulationSymbicort® Turbohaler® - ITT PopulationTotal
Female171229
Male359361720
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CHF 1535 100/6 µg pMDI - ITT PopulationSymbicort® Turbohaler® - ITT PopulationTotal
American Indian or Alaska Native000
Asian376373749
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)CHF 1535 100/6 µg pMDI - ITT PopulationSymbicort® Turbohaler® - ITT PopulationTotal
China376373749
08

Study locations

53 sites
  • Site 15604 - Anhui Provincial Hospital
    Hefei, Anhui 230001, China
  • Site 15635 - The Second Hospital of Anhui Medical Hospital
    Hefei, Anhui 231200, China
  • Site 15613 - Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing Municipality 100050, China
  • Site 15611 - Xuanwu Hospital Capital Medical University
    Beijing, Beijing Municipality 100053, China
  • Site 15640 - Peking University Shougang Hospital
    Beijing, Beijing Municipality 100144, China
  • Site 15626 - Peking University Third Hospital
    Beijing, Beijing Municipality 100191, China
  • Site 15612 - Beijing Tong Ren Hospital, Capital Medical University
    Beijing, Beijing Municipality 100730, China
  • Site 15634 - Chongqing General Hospital
    Chongqing, Chongqing Municipality 400013, China
  • Site 15616 - Chongqing Red Cross Hospital, People's Hospital of Jiangbei District
    Chongqing, Chongqing Municipality 400020, China
  • Site 15636 - Fujian Province Hospital
    Fuzhou, Fujian 350001, China
  • Site 15650 - The First Hospital of Lanzhou University
    Lanzhou, Gansu 730000, China
  • Site 15630 - Dongguan People's Hospital
    Dongguan, Guangdong 523059, China
  • Site 15607 - The First People's Hospital of Shunde
    Foshan, Guangdong 528300, China
  • Site 15619 - The Third Affiliated Hospital of Southern Medical University
    Guangzhou, Guangdong 510000, China
  • Site 15608 - The First Affiliated Hospital Sun Yat-sen University
    Guangzhou, Guangdong 510030, China
  • Site 15646 - The Second Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510260, China
  • Site 15651 - The Second Xiangya Hospital of Central South University
    Guangzhou, Guangdong 510260, China
  • Site 15614 - Guangzhou Panyu central hospital
    Guangzhou, Guangdong 511400, China
  • Site 15618 - Affiliated Hospital of Guangdong Medical University
    Zhanjiang, Guangdong 524000, China
  • Site 15656 - The People's Hospital of Guangxi Zhuang Autonomous Region
    Nanning, Guangxi Zhuang 530021, China
  • Site 15637 - Affiliated Hospital of Zunyi Medical College
    Zunyi, Guizhou 563099, China
  • Site 15623 - Haikou People's Hospital
    Haikou, Hainan 570208, China
  • Site 15645 - Hainan General Hospital
    Haikou, Hainan 570311, China
  • Site 15654 - Henan Provincial People's Hospital
    Zhengzhou, Henan 450003, China
  • Site 15617 - Henan Provincial Chest Hospital
    Zhengzhou, Henan 450008, China
  • Site 15622 - The Third Hospital of Changsha
    Changsha, Hu'nan 410015, China
  • Site 15647 - The Second hospital. University of South China
    Hengyang, Hu'nan 421001, China
  • Site 15653 - Xiangtan Central Hospital
    Xiangtan, Hu'nan 411100, China
  • Site 15603 - The Affiliated Hospital of Inner Mongolia Medical University
    Hohhot, Inner Mongolia 010050, China
  • Site 15657 - Zhong Da Hospital, Southeast University
    Nanjing, Jiangsu 210009, China
  • Site 15627 - Nanjing Medical University Affiliated 2nd Hospital
    Nanjing, Jiangsu 210011, China
  • Site 15621 - Wuxi People's Hospital
    Wuxi, Jiangsu 241023, China
  • Site 15632 - Xuzhou Central Hospital
    Xuzhou, Jiangsu 221009, China
  • Site 15659 - Jiangxi Provincial People's Hospital
    Nanchang, Jiangxi 330006, China
  • Site 15658 - Jilin Province People's Hospital
    Changchun, Jilin 130021, China
  • Site 15643 - No.2 Hospital Affiliated to Jilin University
    Changchun, Jilin 130041, China
  • Site 15648 - Dalian Municipal Central Hospital Affiliated of Dalian Medical University
    Dalian, Liaoning 116033, China
  • Site 15649 - The 1st Affiliated Hospital of Shanxi Medical University
    Taiyuan, Shan'xi 030001, China
  • Site 15644 - Jinan Central Hospital
    Jinan, Shandong 250013, China
  • Site 15629 - Shanghai East Hospital
    Shanghai, Shanghai Municipality 2000120, China
  • Site 15628 - Shanghai Xuhui Center Hospital
    Shanghai, Shanghai Municipality 200031, China
  • Site 15601 - Huadong Hospital Afflilliated to Fudan University
    Shanghai, Shanghai Municipality 200040, China
  • Site 15631 - Shanghai Yangpu District Centre Hospital
    Shanghai, Shanghai Municipality 200090, China
  • Site 15610 - Tong Ren Hospital Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai Municipality 200336, China
  • Site 15606 - Shanghai Pulmonary Hospital
    Shanghai, Shanghai Municipality 200433, China
  • Site 15625 - Central Hospital of Shanghai Minhang District
    Shanghai, Shanghai Municipality 201199, China
  • Site 15638 - Second Hospital of Shanxi Medical
    Taiyuan, Shanxi 0300001, China
  • Site 15605 - West China Hospital, Sichuan University
    Chengdu, Sichuan 610041, China
  • Site 15609 - Tianjin First Center Hospital
    Tianjin, Tianjin Municipality 300192, China
  • Site 15633 - Tianjin Haihe Hospital
    Tianjin, Tianjin Municipality 300350, China
  • Site 15602 - Hangzhou First People's Hospital
    Hangzhou, Zhejiang 310006, China
  • Site 15642 - Taizhou Hospital of Zhejiang Province
    Taizhou, Zhejiang 317000, China
  • Site 15639 -The second Affiliated Hospital of Wenzhou Medical College
    Wenzhou, Zhejiang 325027, China
09

References and documents

Publications

  • Wen F, Wu Y, Xing C, Zhu Y, Chen Y, Mei X, Corradi M, Cappellini G, Calabro E, Amodio S, Zhu C, Galkin D. Beclometasone Dipropionate/Formoterol Fumarate is Similarly Effective to Budesonide/Formoterol Fumarate in Chinese Patients with COPD: The FORSYYN Double-Blind, Randomised Study. COPD. 2024 Dec;21(1):2425157. doi: 10.1080/15412555.2024.2425157. Epub 2024 Nov 11. PubMed 39529298 ↗

Study documents

  • Study protocol · Nov 9, 2017
  • Statistical analysis plan · Jul 29, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03888131
Lead sponsor
Chiesi Farmaceutici S.p.A.
Responsible party
Sponsor
First posted
Mar 25, 2019
Start date
Jul 30, 2018
Primary completion
May 6, 2022
Completion
May 6, 2022
Results posted
May 12, 2026
Last update
May 12, 2026

Study contacts

Professor Fuqiang WEN, M.D., Ph.D.
principal investigator · West China Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Other studies from this sponsor

Chiesi Farmaceutici S.p.A.

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