A Phase 3 interventional study of Foster 100/6µg NEXThaler and Foster 100/6µg pMDI in Asthma, sponsored by Chiesi Farmaceutici S.p.A.. Completed at 51 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Chiesi Farmaceutici S.p.A. · Phase 3, Interventional, and Treatment
Primary Objective
To demonstrate the non-inferiority of Foster® NEXThaler® 100/6 µg versus (vs.) Foster® pressurised metered dose inhaler (pMDI) 100/6 µg in terms of pulmonary function (change from baseline to the entire treatment period in average pre-dose morning peak expiratory flow [PEF]) in asthmatic patients.
Secondary Objectives
To evaluate the effect of the test treatments in terms of additional lung function parameters and clinical outcome measures, and to assess the safety and tolerability.
This was a phase III, multinational, multicentre, randomised, double-blind, double-dummy, active-control, 2-arm parallel group study designed to evaluate the non-inferiority of Foster® NEXThaler® 100/6 µg (400/24 µg/day) versus Foster® pMDI 100/6 µg (400/24 µg/day) in patients with controlled asthma.
The study included the following phases:
Daily, patients recorded pre-dose morning and evening Peak Expiratory Flow (PEF), rescue medication use, and asthma symptoms using an electronic peak flow meter and e-diary. At each visit, lung function (FEV1, FVC, and PEF), asthma symptom scores, and rescue medication use were assessed. Vital signs (heart rate, blood pressure) and safety outcomes (adverse events, serious adverse events, and laboratory assessments) were monitored.
The total study duration per participant was 16 weeks, including the 4-week run-in period, 12-week treatment phase, and 1-week follow-up. This design ensured a standardized baseline before randomisation and provided sufficient time to assess both primary and secondary endpoints.
Salbutamol (purchased locally and provided by the Investigator site to the patient) was used as a rescue medication.
Clinical diagnosis of asthma for a minimum of 6 months prior to V1 (Week -4) confirmed by a chest physician according to international guidelines updated 2018 (GINA) [1]. The evidence of asthma had to be confirmed through a documented positive response (in the last 24 months) either to a bronchial provocation test/challenge test or a reversibility test. In case the patient did not have any documented reversibility test or provocation/challenge test, a salbutamol reversibility test was performed at V1 (Week -4) within 10 to 30 minutes after administration of 400 µg of salbutamol pMDI [17]. Test response was positive if ΔFEV1 ≥12% and ≥200 mL over baseline.
Note: In case the reversibility threshold was not met at V1 (Week -4), the test could have been repeated once before V2 or at V2 (Week -2);
FEV1 >80% of the predicted normal value after appropriate washout from bronchodilators (checked at V1 [Week -4] and at the randomisation visit [V3, Week 0]);
Note: If this criterion was not met:
Exclusion Criteria:
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:
Pregnancy testing was carried out during the course of the study in all women of childbearing potential: serum pregnancy test was performed at screening (V1, Week -4) and end of treatment (V9, Week 12), urine pregnancy test was performed at all visits except V0 (Week -5) and V9 (Week 12);
Patients in this arm received Foster® NEXThaler® 100/6 µg, a fixed-dose combination of beclometasone dipropionate (BDP) 100 µg and formoterol fumarate (FF) 6 µg per actuation, delivered via a breath-actuated dry powder inhaler (DPI). Treatment Details: * Dosage: 2 inhalations twice daily (b.i.d.), totaling 400/24 µg BDP/FF daily. * Duration: 12 weeks. * Administration: First dose under medical supervision at randomization (Week 0). Blinding \& Control Treatment: * A double-dummy design was used. Patients also received a placebo pMDI (matching active pMDI), administered as 2 puffs b.i.d. to maintain blinding. Background Therapy: * Salbutamol was provided as rescue medication. Patient Training \& Compliance: * Inhaler use was assessed at visits, with retraining as needed; patients used an AeroChamber Plus™ spacer if necessary, and each inhaler was labeled with "sun" (morning) and "moon" (evening) stickers.
Drug: Foster 100/6µg NEXThaler
Patients in this arm received Foster® pMDI 100/6 µg, a fixed-dose combination of beclometasone dipropionate (BDP) 100 µg and formoterol fumarate (FF) 6 µg per actuation, delivered via a pressurized metered-dose inhaler (pMDI). Treatment Details: * Dosage: 2 puffs twice daily (b.i.d.), totaling 400/24 µg BDP/FF daily. * Duration: 12 weeks. * Administration: First dose under medical supervision at randomization (Week 0). Blinding \& Control Treatment: * A double-dummy design was used. Patients also received a placebo DPI (matching active DPI), administered as 2 inhalations b.i.d. to maintain blinding. Background Therapy: * Salbutamol was provided as rescue medication. Patient Training \& Compliance: * Inhaler use was assessed at visits, with retraining as needed; patients used an AeroChamber Plus™ spacer if necessary, and each inhaler was labeled with "sun" (morning) and "moon" (evening) stickers.
Drug: Foster 100/6µg pMDI
A fixed combination of beclometasone dipropionate 100 µg and formoterol fumarate 6 µg per actuation, delivered via a breath-actuated dry powder inhaler (DPI).
Also known as: beclometasone dipropionate (BDP) 100 µg / formoterol fumarate (FF) 6 µg NEXThealer
A fixed combination of beclometasone dipropionate 100 µg and formoterol fumarate 6 µg per actuation, delivered via a pressurized metered-dose inhaler (pMDI) with HFA\_134a propellant.
Also known as: beclometasone dipropionate (BDP) 100µg / formoterol fumarate (FF) 6µg pMDI
Change From Baseline to End of Treatment Period in Average Pre-dose Morning Peak Expiratory Flow (PEF)
PEF= peak expiratory flow. The peak expiratory flow (also known as a peak flow or peak flow rate) is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. In this study PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded. * Baseline pre-dose morning PEF was calculated as the mean of all valid pre-dose morning Best PEF values from the last 14 days before randomization (Week 0, Visit 3). * The average pre-dose morning PEF over the entire treatment period was computed as: ∑Valid pre-dose morning Best PEF values (treatment period) / Number of days with available data * Valid pre-dose morning Best PEF values = Highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min
Time frame: Baseline (Week 0, Visit 3) and Week 12 (EoT)
Change From Baseline to Each 2-week (Inter-visit) Treatment Period in Average Pre-dose Morning Peek Expiratory Flow (PEF)
PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: in the morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded. * Baseline pre-dose morning PEF was calculated as the mean of all valid pre-dose morning Best PEF values from the last 14 days before randomization (Week 0, Visit 3). * The average pre-dose morning PEF for each inter-visit period was computed as: ∑all valid pre-dose morning Best PEF values / number of days with available data * Valid pre-dose morning Best PEF values = Highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min
Time frame: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Pre-dose Evening PEF
PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded. * Baseline pre-dose evening PEF was calculated as the mean of all valid pre-dose evening Best PEF values from the last 14 days before randomization (Week 0, Visit 3). * The average pre-dose evening PEF for each inter-visit period was computed as: ∑all valid pre-dose evening Best PEF values / number of days with available data * Valid pre-dose evening Best PEF values = Highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min.
Time frame: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks.
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Daily PEF Variability
PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded. * Baseline average daily PEF variability was calculated as the mean of all daily PEF variability values recorded in the last 14 days before randomization (Week 0, Visit 3). * The average daily PEF variability for each inter-visit period was computed as: ∑all daily PEF variability values / number of days with available data * Daily PEF variability was calculated only for days where both pre-dose morning Best PEF and pre-dose evening Best PEF values were available. * Valid Best PEF values were defined as the highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min.
Time frame: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Use of Rescue Medication (Number of Puffs/Day)
Rescue medication use was recorded daily in an electronic diary, with puffs taken during the day recorded in the evening session and puffs taken at night recorded the next morning. * Baseline rescue medication use was the mean daily use over the last 14 days before randomization (Week 0, Visit 3). * Average daily use of rescue medication was calculated as: * all puffs per day / number of days with available data * It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the entire treatment period (from the evening of the first treatment day to the morning of the last). * At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
Time frame: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Percentage of Rescue Medication-Free Days
Rescue medication use was recorded daily in an electronic diary, with puffs taken during the day recorded in the evening session and puffs taken at night recorded the next morning. * Baseline percentage of rescue medication-free days was calculated over the last 14 days before randomization (Week 0, Visit 3). * Percentage of rescue medication-free days was calculated as: (Number of days with no rescue medication use / Total number of days with available data)×100 * It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the entire treatment period (from the evening of the first treatment day to the morning of the last). * At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
Time frame: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Total Morning Asthma Symptom Score
Asthma symptoms (cough, wheeze, chest tightness and breathlessness) were scored, always before PEF measurements, twice daily - daytime and nighttime - as follows: Daytime asthma symptom score (ranging 0-3, where the lower the score the better the outcome): 0 No symptom 1. Mild: symptoms not causing awakening 2. Moderate: discomfort causing awakenings 3. Severe: causing awakenings for most of the night / don't allow to sleep at all The average score of each symptom is the mean value of all measurements (recorded in the evening session, as per study methodology). Total average Daily Asthma Symptoms score daytime = Σ(Cough daytime score + Wheeze daytime score + Chest Tightness daytime score + Breathlessness daytime score)/ Number of days with available data. The average of daytime asthma symptoms is the mean value of all daytime measurements, ranging from 0 (no symptoms) to 12 (maximum severity). The lower the score, the better the symptom.
Time frame: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Average Total Evening Asthma Symptom Scores
Asthma symptoms (cough, wheeze, chest tightness and breathlessness) were scored, always before PEF measurements, twice daily - daytime and nighttime - as follows: Nighttime asthma symptom score (ranging 0-3, where the lower the score the better the outcome): 0 No symptom 1. Mild: symptoms not causing awakening 2. Moderate: discomfort causing awakenings 3. Severe: causing awakenings for most of the night / don't allow to sleep at all The average score of each symptom is the mean value of all measurements (Recorded in the morning session of the next day). Total average Daily Asthma Symptoms score nighttime = Σ(Cough nighttime score + Wheeze nighttime score + Chest Tightness nighttime score + Breathlessness nighttime score)/ Number of days with available data. The average of nighttime asthma symptoms is the mean value of all nighttime measurements, ranging from 0 (no symptoms) to 12 (maximum severity). The lower the score, the better the symptom.
Time frame: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Percentage of Asthma Symptom-Free Days
An asthma symptom-free day was defined as a day with both total morning and total evening asthma symptom scores = 0. Only days with both scores available were included. * Baseline percentage of symptom-free days was the mean percentage over the last 14 days before randomization (Week 0, Visit 3). * Percentage of asthma symptom-free days was calculated as: (Number of symptom-free days / Total number of days with available data)×100 * It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the 12-week treatment period (from the evening of treatment start to the morning of treatment end). * At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
Time frame: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline to Each 2-week (Inter-visit) Treatment Period and to the Entire Treatment Period in Percentage of Asthma Control Days
An asthma control day was defined as a day without rescue medication use and with both total morning and total evening asthma symptom scores = 0. Only days with both scores available were included in the calculation. * Baseline percentage of asthma control days was the mean percentage over the last 14 days before randomization (Week 0, Visit 3). * Percentage of asthma control days was calculated as: (Number of asthma control days / Total number of days with available data)×100 * It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the 12-week treatment period (from the evening of treatment start to the morning of treatment end). * At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
Time frame: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT) and across the 12 weeks
Change From Baseline in Pre-Dose Morning FEV1 at Each Clinic Visit
Forced Expiratory Volume in 1 second (FEV1) was measured pre-dose in the morning (7:00-9:00 am) at each clinic visit using spirometry, following standardized procedures. Baseline FEV1 was recorded at Visit 3 (Week 0, randomization), and changes were assessed at each visit (Weeks 2, 4, 6, 8, 10, and 12). Patients performed spirometry in a seated position, using the same calibrated spirometer across all visits. They inhaled deeply to total lung capacity and exhaled forcefully and completely. At least three acceptable maneuvers were required, with the highest valid measurement recorded. FEV1 was expressed in liters (L), and a higher value indicated better lung function.
Time frame: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
Change From Baseline in Pre-Dose Morning FVC at Each Clinic Visit
Forced vital capacity (FVC) is the maximum capacity of air that a patient can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. FVC was measured pre-dose in the morning (7:00-9:00 am) at each clinic visit using spirometry, following standardized procedures. Baseline FVC was recorded at Visit 3 (Week 0, randomization), and changes were assessed at each visit (Weeks 2, 4, 6, 8, 10, and 12). Patients performed spirometry in a seated position, ensuring consistency across visits. They were instructed to inhale deeply to full lung capacity and exhale forcefully and completely into the spirometer. At least three acceptable maneuvers were required per session, with the highest valid measurement recorded. The higher the capacity, measured in liters, the better the outcome.
Time frame: Baseline (Visit 3, Week 0, Randomization), Week 2 (Visit 4), Week 4 (Visit 5), Week 6 (Visit 6), Week 8 (Visit 7), Week 10 (Visit 8), Week 12 (Visit 9, End of Treatment - EOT)
Change From Baseline to Last Visit in ACQ-6 Score
The ACQ-6 was a validated questionnaire assessing asthma control, consisting of six items: five on asthma symptoms (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and one on rescue medication use, all self-administered. Each item was scored from 0 (no impairment) to 6 (maximum impairment), and the ACQ-6 total score was the mean of all six items, ranging from 0 (totally controlled asthma) to 6 (severely uncontrolled asthma). Hence, the higher the score, the worse the outcome. Baseline ACQ-6 was assessed at Visit 3 (Week 0, randomization), and the final score was recorded at Visit 9 (Week 12, EOT). The change from baseline was calculated as the difference between these values .
Time frame: Week 12 (Visit 9, End of Treatment - EOT)
Number of Participants With at Least One Adverse Event (TEAE) or Adverse Drug Reaction (ADR)
An adverse event (AE) was defined as "any untoward medical occurrence in a patient or clinical study patient administered a medicinal product and which did not necessarily have a causal relationship with this treatment". An AE could therefore be any unfavourable and unintended sign (including abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An adverse drug reaction (ADR) was defined as an "untoward and unintended response to an investigational medicinal product related to any dose administered". An SAE/serious ADR was defined as any untoward medical occurrence or effect that at any dose Resulted in death, Was life-threatening, Required hospitalisation or prolongation of existing hospitalisation, Resulted in persistent or significant disability or incapacity, Was a congenital anomaly or birth defect, Was a medically significant AE.
Time frame: From Week 0 (Visit 3, Randomization) to Week 12 (Visit 9, EoT)
The trial began Oct 2017 and completed in Dec 2021, including the period COVID19 pandemic occurred in China. Enrollment in the 46 active sites was paused from Feb 2020, resuming from March 2020 in 8 sites and by 15 June 2020 in 38 sites. Of the patients screened, 494 entered a 4-week run-in period (V1, week -4) and afterward were enrolled and randomized (V3, week 0) into the two treatment groups: * Foster® NEXThaler® 100/6 µg Arm (n=252) * Foster® pMDI 100/6 µg Arm (n=242)
| Milestone | Foster 100/6µg NEXThaler | Foster 100/6µg pMDI |
|---|---|---|
| Started | 252 | 242 |
| Safety (saf) population | 252 | 242 |
| Intention-to-treat (itt) population | 251 | 242 |
| Per protocol (pp) population | 236 | 223 |
| Completed | 223 | 215 |
| Not completed | 29 | 27 |
| Withdrew: Other reason | 17 | 15 |
| Withdrew: Adverse event | 8 | 4 |
| Withdrew: Withdrawal by subject | 2 | 4 |
| Withdrew: Lack of efficacy | 2 | 2 |
| Withdrew: Protocol violation | 0 | 2 |
PEF= peak expiratory flow. The peak expiratory flow (also known as a peak flow or peak flow rate) is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. In this study PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded. * Baseline pre-dose morning PEF was calculated as the mean of all valid pre-dose morning Best PEF values from the last 14 days before randomization (Week 0, Visit 3). * The average pre-dose morning PEF over the entire treatment period was computed as: ∑Valid pre-dose morning Best PEF values (treatment period) / Number of days with available data * Valid pre-dose morning Best PEF values = Highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min
| L/min | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT |
|---|---|---|
| Change From Baseline to End of Treatment Period in Average Pre-dose Morning Peak Expiratory Flow (PEF) | 7.05 ± 34.45 | 1.42 ± 34.80 |
PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: in the morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded. * Baseline pre-dose morning PEF was calculated as the mean of all valid pre-dose morning Best PEF values from the last 14 days before randomization (Week 0, Visit 3). * The average pre-dose morning PEF for each inter-visit period was computed as: ∑all valid pre-dose morning Best PEF values / number of days with available data * Valid pre-dose morning Best PEF values = Highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min
| L/min | Foster 100/6mg NEXThaler - ITT | Foster 100/6µg pMDI - ITT |
|---|---|---|
| V3, Week 0 - V4, Week 2 | 4.96 ± 28.67 | 1.82 ± 27.85 |
| V4, Week 2 - V5, Week 4 | 7.12 ± 39.77 | -0.17 ± 36.95 |
| V5, Week 4 - V6, Week 6 | 7.63 ± 39.44 | 1.70 ± 39.98 |
| V6, Week 6 - V7, Week 8 | 6.97 ± 41.69 | 5.08 ± 41.10 |
| V7, Week 8 - V8, Week 10 | 9.73 ± 45.60 | 1.05 ± 43.81 |
| V8, Week 10 - V9, Week 12 | 10.15 ± 44.94 | 1.40 ± 46.72 |
PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded. * Baseline pre-dose evening PEF was calculated as the mean of all valid pre-dose evening Best PEF values from the last 14 days before randomization (Week 0, Visit 3). * The average pre-dose evening PEF for each inter-visit period was computed as: ∑all valid pre-dose evening Best PEF values / number of days with available data * Valid pre-dose evening Best PEF values = Highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min.
| L/min | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT |
|---|---|---|
| V3, Week 0 - V4, Week 2 | 3.70 ± 28.39 | 0.79 ± 28.67 |
| V4, Week 2 - V5, Week 4 | 4.69 ± 40.36 | -2.91 ± 36.75 |
| V5, Week 4 - V6, Week 6 | 5.40 ± 39.12 | -0.56 ± 38.97 |
| V6, Week 6 - V7, Week 8 | 3.36 ± 39.98 | 2.36 ± 38.75 |
| V7, Week 8 - V8, Week 10 | 7.13 ± 45.15 | -1.69 ± 42.28 |
| V8, Week 10 - V9, Week 12 | 6.59 ± 45.30 | -3.51 ± 44.80 |
| Entire Treatment Period (Week 0 - Week 12) | 4.55 ± 33.86 | -1.64 ± 34.13 |
PEF (L/min) was monitored twice daily using a portable electronic peak flow meter before medication intake: morning (7:00-9:00 am) and evening (7:00-9:00 pm). Each session required at least two blows, with the highest valid value recorded. * Baseline average daily PEF variability was calculated as the mean of all daily PEF variability values recorded in the last 14 days before randomization (Week 0, Visit 3). * The average daily PEF variability for each inter-visit period was computed as: ∑all daily PEF variability values / number of days with available data * Daily PEF variability was calculated only for days where both pre-dose morning Best PEF and pre-dose evening Best PEF values were available. * Valid Best PEF values were defined as the highest value recorded from at least two PEF measurements per session, within the range 50-900 L/min.
| L/min | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT |
|---|---|---|
| Visit 3 (Week 0) - Visit 4 (Week 2) | -0.40 ± 5.44 | -0.62 ± 5.20 |
| Visit 4 (Week 2) - Visit 5 (Week 4) | -0.87 ± 6.02 | -1.02 ± 5.98 |
| Visit 5 (Week 4) - Visit 6 (Week 6) | -0.65 ± 5.77 | -0.71 ± 5.58 |
| Visit 6 (Week 6) - Visit 7 (Week 8) | -1.10 ± 6.00 | -0.75 ± 5.48 |
| Visit 7 (Week 8)- Visit 8 (Week 10) | -0.96 ± 5.85 | -0.90 ± 6.17 |
| Visit 8 (Week 10) - Visit 9 (Week 12) | -0.99 ± 5.65 | -1.55 ± 6.88 |
| Entire Treatment Period (Week 0 - Week 12) | -0.79 ± 4.58 | -1.03 ± 4.74 |
Rescue medication use was recorded daily in an electronic diary, with puffs taken during the day recorded in the evening session and puffs taken at night recorded the next morning. * Baseline rescue medication use was the mean daily use over the last 14 days before randomization (Week 0, Visit 3). * Average daily use of rescue medication was calculated as: * all puffs per day / number of days with available data * It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the entire treatment period (from the evening of the first treatment day to the morning of the last). * At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
| puffs/day | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT |
|---|---|---|
| Visit 3 (Week 0) - Visit 4 (Week 2) | -0.005 ± 0.083 | -0.009 ± 0.266 |
| Visit 4 (Week 2) - Visit 5 (Week 4) | 0.017 ± 0.201 | -0.033 ± 0.266 |
| Visit 5 (Week 4) - Visit 6 (Week 6) | -0.004 ± 0.112 | -0.036 ± 0.264 |
| Visit 6 (Week 6) - Visit 7 (Week 8) | -0.002 ± 0.126 | -0.026 ± 0.313 |
| Visit 7 (Week 8) - Visit 8 (Week 10) | -0.002 ± 0.117 | -0.031 ± 0.329 |
| Visit 8 (Week 10) - Visit 9 (Week 12) | 0.007 ± 0.158 | -0.024 ± 0.301 |
| Entire Treatment Period (Week 0 - Week 12) | 0.002 ± 0.107 | -0.025 ± 0.260 |
Rescue medication use was recorded daily in an electronic diary, with puffs taken during the day recorded in the evening session and puffs taken at night recorded the next morning. * Baseline percentage of rescue medication-free days was calculated over the last 14 days before randomization (Week 0, Visit 3). * Percentage of rescue medication-free days was calculated as: (Number of days with no rescue medication use / Total number of days with available data)×100 * It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the entire treatment period (from the evening of the first treatment day to the morning of the last). * At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
| Percentage of days | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT |
|---|---|---|
| Visit 3 (Week 0) - Visit 4 (Week 2) | 0.23 ± 4.64 | 0.24 ± 8.59 |
| Visit 4 (Week 2) - Visit 5 (Week 4) | -0.62 ± 7.61 | 1.03 ± 8.79 |
| Visit 5 (Week 4) - Visit 6 (Week 6) | 0.32 ± 5.47 | 1.32 ± 8.95 |
| Visit 6 (Week 6) - Visit 7 (Week 8) | 0.23 ± 5.93 | 0.83 ± 11.27 |
| Visit 7 (Week 8) - Visit 8 (Week 10) | 0.18 ± 5.76 | 0.90 ± 11.24 |
| Visit 8 (Week 10) - Visit 9 (Week 12) | -0.22 ± 7.59 | 1.02 ± 11.27 |
| Entire Treatment Period (Week 0 - Week 12) | 0.02 ± 5.05 | 0.82 ± 8.61 |
Asthma symptoms (cough, wheeze, chest tightness and breathlessness) were scored, always before PEF measurements, twice daily - daytime and nighttime - as follows: Daytime asthma symptom score (ranging 0-3, where the lower the score the better the outcome): 0 No symptom 1. Mild: symptoms not causing awakening 2. Moderate: discomfort causing awakenings 3. Severe: causing awakenings for most of the night / don't allow to sleep at all The average score of each symptom is the mean value of all measurements (recorded in the evening session, as per study methodology). Total average Daily Asthma Symptoms score daytime = Σ(Cough daytime score + Wheeze daytime score + Chest Tightness daytime score + Breathlessness daytime score)/ Number of days with available data. The average of daytime asthma symptoms is the mean value of all daytime measurements, ranging from 0 (no symptoms) to 12 (maximum severity). The lower the score, the better the symptom.
| score on a scale | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT |
|---|---|---|
| Visit 3 (Week 0) - Visit 4 (Week 2) | -0.07 ± 0.32 | -0.07 ± 0.38 |
| Visit 4 (Week 2) - Visit 5 (Week 4) | -0.10 ± 0.38 | -0.12 ± 0.52 |
| Visit 5 (Week 4) - Visit 6 (Week 6) | -0.12 ± 0.40 | -0.16 ± 0.53 |
| Visit 6 (Week 6) - Visit 7 (Week 8) | -0.11 ± 0.37 | -0.15 ± 0.54 |
| Visit 7 (Week 8) - Visit 8 (Week 10) | -0.14 ± 0.38 | -0.13 ± 0.54 |
| Visit 8 (Week 10) - Visit 9 (Week 12) | -0.15 ± 0.38 | -0.15 ± 0.57 |
| Entire Treatment Period (Week 0 - Week 12) | -0.11 ± 0.35 | -0.13 ± 0.48 |
Asthma symptoms (cough, wheeze, chest tightness and breathlessness) were scored, always before PEF measurements, twice daily - daytime and nighttime - as follows: Nighttime asthma symptom score (ranging 0-3, where the lower the score the better the outcome): 0 No symptom 1. Mild: symptoms not causing awakening 2. Moderate: discomfort causing awakenings 3. Severe: causing awakenings for most of the night / don't allow to sleep at all The average score of each symptom is the mean value of all measurements (Recorded in the morning session of the next day). Total average Daily Asthma Symptoms score nighttime = Σ(Cough nighttime score + Wheeze nighttime score + Chest Tightness nighttime score + Breathlessness nighttime score)/ Number of days with available data. The average of nighttime asthma symptoms is the mean value of all nighttime measurements, ranging from 0 (no symptoms) to 12 (maximum severity). The lower the score, the better the symptom.
| score on a scale | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT |
|---|---|---|
| Visit 3 (Week 0) - Visit 4 (Week 2) | -0.07 ± 0.29 | -0.04 ± 0.29 |
| Visit 4 (Week 2) - Visit 5 (Week 4) | -0.10 ± 0.31 | -0.08 ± 0.44 |
| Visit 5 (Week 4) - Visit 6 (Week 6) | -0.10 ± 0.35 | -0.09 ± 0.48 |
| Visit 6 (Week 6) - Visit 7 (Week 8) | -0.10 ± 0.36 | -0.09 ± 0.49 |
| Visit 7 (Week 8) - Visit 8 (Week 10) | -0.13 ± 0.37 | -0.10 ± 0.53 |
| Visit 8 (Week 10) - Visit 9 (Week 12) | -0.13 ± 0.38 | -0.09 ± 0.52 |
| Entire Treatment Period (Week 0 - Week 12) | -0.10 ± 0.32 | -0.08 ± 0.42 |
An asthma symptom-free day was defined as a day with both total morning and total evening asthma symptom scores = 0. Only days with both scores available were included. * Baseline percentage of symptom-free days was the mean percentage over the last 14 days before randomization (Week 0, Visit 3). * Percentage of asthma symptom-free days was calculated as: (Number of symptom-free days / Total number of days with available data)×100 * It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the 12-week treatment period (from the evening of treatment start to the morning of treatment end). * At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
| Percentage of days | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT |
|---|---|---|
| Visit 3 (Week 0) - Visit 4 (Week 2) | 4.44 ± 18.21 | 3.69 ± 18.82 |
| Visit 4 (Week 2) - Visit 5 (Week 4) | 6.96 ± 24.27 | 7.28 ± 26.58 |
| Visit 5 (Week 4) - Visit 6 (Week 6) | 9.23 ± 26.10 | 9.84 ± 26.04 |
| Visit 6 (Week 6) - Visit 7 (Week 8) | 9.25 ± 25.73 | 8.98 ± 25.98 |
| Visit 7 (Week 8) - Visit 8 (Week 10) | 11.61 ± 28.45 | 9.64 ± 26.08 |
| Visit 8 (Week 10) - Visit 9 (Week 12) | 12.22 ± 27.75 | 9.14 ± 28.08 |
| Entire Treatment Period (Week 0 - Week 12) | 8.44 ± 22.58 | 7.91 ± 23.04 |
An asthma control day was defined as a day without rescue medication use and with both total morning and total evening asthma symptom scores = 0. Only days with both scores available were included in the calculation. * Baseline percentage of asthma control days was the mean percentage over the last 14 days before randomization (Week 0, Visit 3). * Percentage of asthma control days was calculated as: (Number of asthma control days / Total number of days with available data)×100 * It was assessed for each inter-visit period (from the evening of the clinic visit to the morning of the next visit) and over the 12-week treatment period (from the evening of treatment start to the morning of treatment end). * At least 7 valid days were required per period, with at least one evaluable inter-visit period needed for full analysis.
| Percentage of days | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT |
|---|---|---|
| Visit 3 (Week 0) - Visit 4 (Week 2) | 4.61 ± 18.60 | 3.07 ± 18.71 |
| Visit 4 (Week 2) - Visit 5 (Week 4) | 6.40 ± 25.33 | 7.17 ± 26.56 |
| Visit 5 (Week 4) - Visit 6 (Week 6) | 9.51 ± 26.05 | 9.88 ± 26.08 |
| Visit 6 (Week 6) - Visit 7 (Week 8) | 9.49 ± 26.02 | 9.12 ± 25.96 |
| Visit 7 (Week 8) - Visit 8 (Week 10) | 11.79 ± 28.43 | 9.58 ± 26.15 |
| Visit 8 (Week 10) - Visit 9 (Week 12) | 12.11 ± 28.24 | 9.29 ± 28.24 |
| Entire Treatment Period (Week 0 - Week 12) | 8.44 ± 22.79 | 7.78 ± 22.90 |
Forced Expiratory Volume in 1 second (FEV1) was measured pre-dose in the morning (7:00-9:00 am) at each clinic visit using spirometry, following standardized procedures. Baseline FEV1 was recorded at Visit 3 (Week 0, randomization), and changes were assessed at each visit (Weeks 2, 4, 6, 8, 10, and 12). Patients performed spirometry in a seated position, using the same calibrated spirometer across all visits. They inhaled deeply to total lung capacity and exhaled forcefully and completely. At least three acceptable maneuvers were required, with the highest valid measurement recorded. FEV1 was expressed in liters (L), and a higher value indicated better lung function.
| liters | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT |
|---|---|---|
| Visit 4 (Week 2) | -0.040 ± 0.199 | -0.036 ± 0.233 |
| Visit 5 (Week 4) | -0.028 ± 0.248 | -0.033 ± 0.207 |
| Visit 6 (Week 6) | -0.037 ± 0.259 | -0.046 ± 0.221 |
| Visit 7 (Week 8) | -0.050 ± 0.257 | -0.040 ± 0.222 |
| Visit 8 (Week 10) | -0.039 ± 0.261 | -0.063 ± 0.232 |
| Visit 9 (Week 12) | -0.034 ± 0.246 | -0.044 ± 0.230 |
Forced vital capacity (FVC) is the maximum capacity of air that a patient can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. FVC was measured pre-dose in the morning (7:00-9:00 am) at each clinic visit using spirometry, following standardized procedures. Baseline FVC was recorded at Visit 3 (Week 0, randomization), and changes were assessed at each visit (Weeks 2, 4, 6, 8, 10, and 12). Patients performed spirometry in a seated position, ensuring consistency across visits. They were instructed to inhale deeply to full lung capacity and exhale forcefully and completely into the spirometer. At least three acceptable maneuvers were required per session, with the highest valid measurement recorded. The higher the capacity, measured in liters, the better the outcome.
| liters | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT |
|---|---|---|
| Visit 4 (Week 2) | -0.023 ± 0.176 | -0.033 ± 0.193 |
| Visit 5 (Week 4) | -0.027 ± 0.237 | -0.047 ± 0.207 |
| Visit 6 (Week 6) | -0.020 ± 0.270 | -0.056 ± 0.221 |
| Visit 7 (Week 8) | -0.026 ± 0.270 | -0.056 ± 0.211 |
| Visit 8 (Week 10) | -0.037 ± 0.256 | -0.076 ± 0.218 |
| Visit 9 (Week 12) | -0.039 ± 0.258 | -0.050 ± 0.216 |
The ACQ-6 was a validated questionnaire assessing asthma control, consisting of six items: five on asthma symptoms (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and one on rescue medication use, all self-administered. Each item was scored from 0 (no impairment) to 6 (maximum impairment), and the ACQ-6 total score was the mean of all six items, ranging from 0 (totally controlled asthma) to 6 (severely uncontrolled asthma). Hence, the higher the score, the worse the outcome. Baseline ACQ-6 was assessed at Visit 3 (Week 0, randomization), and the final score was recorded at Visit 9 (Week 12, EOT). The change from baseline was calculated as the difference between these values .
| score on a scale | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT |
|---|---|---|
| Change From Baseline to Last Visit in ACQ-6 Score | -0.006 ± 0.196 | -0.019 ± 0.208 |
An adverse event (AE) was defined as "any untoward medical occurrence in a patient or clinical study patient administered a medicinal product and which did not necessarily have a causal relationship with this treatment". An AE could therefore be any unfavourable and unintended sign (including abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An adverse drug reaction (ADR) was defined as an "untoward and unintended response to an investigational medicinal product related to any dose administered". An SAE/serious ADR was defined as any untoward medical occurrence or effect that at any dose Resulted in death, Was life-threatening, Required hospitalisation or prolongation of existing hospitalisation, Resulted in persistent or significant disability or incapacity, Was a congenital anomaly or birth defect, Was a medically significant AE.
| Participants | Foster 100/6µg NEXThaler - SAF Population | Foster 100/6µg pMDI - SAF Population |
|---|---|---|
| TEAEs | 122 | 120 |
| Serious TEAEs | 3 | 5 |
| ADRs | 14 | 11 |
| Serious ADRs | 0 | 0 |
| Severe TEAEs | 4 | 4 |
| TEAEs leading to discontinuation from study treatment | 7 | 4 |
| TEAEs leading to death | 0 | 0 |
Collected over AEs were collected from screening (V1, week -2) to End of Treatment (V9, week 12 OR before if patients withdrew) and at follow-up (7-10 days max after last study drug intake - 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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Run-in and Randomized Foster 100/6µg NEXThaler (SAF Population) | 0/252 (0%) | 3/252 (1.2%) | 122/252 (48.4%) |
| Run-in and Randomized Foster 100/6µg pMDI (SAF Population) | 0/242 (0%) | 5/242 (2.1%) | 120/242 (49.6%) |
| Event | Run-in and Randomized Foster 100/6µg NEXThaler (SAF Population) | Run-in and Randomized Foster 100/6µg pMDI (SAF Population) |
|---|---|---|
| CellulitisInfections and infestations | 0/252 | 1/242 |
| Urinary tract infectionInfections and infestations | 0/252 | 1/242 |
| Lumbar spinal stenosisMusculoskeletal and connective tissue disorders | 0/252 | 1/242 |
| Still's diseaseMusculoskeletal and connective tissue disorders | 0/252 | 1/242 |
| Nephritis allergicRenal and urinary disorders | 0/252 | 1/242 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/252 | 1/242 |
| Pulmonary massRespiratory, thoracic and mediastinal disorders | 0/252 | 1/242 |
| Atrial fibrillationCardiac disorders | 1/252 | 0/242 |
| Chronic hepatitis BInfections and infestations | 1/252 | 0/242 |
| Thyroid neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/252 | 0/242 |
| Event | Run-in and Randomized Foster 100/6µg NEXThaler (SAF Population) | Run-in and Randomized Foster 100/6µg pMDI (SAF Population) |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 42/252 | 27/242 |
| NasopharyngitisInfections and infestations | 12/252 | 12/242 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/252 | 12/242 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 12/252 | 10/242 |
| PharyngitisInfections and infestations | 5/252 | 9/242 |
| Rhinitis allergicRespiratory, thoracic and mediastinal disorders | 8/252 | 3/242 |
| BronchitisInfections and infestations | 4/252 | 5/242 |
| HypertensionVascular disorders | 1/252 | 4/242 |
| Chronic gastritisGastrointestinal disorders | 0/252 | 3/242 |
| DiarrhoeaGastrointestinal disorders | 2/252 | 3/242 |
Intention-to-treat (ITT) population: all randomised patients who received at least one dose of the study treatment and with at least one available evaluation of efficacy after baseline
| Age, Continuous(years) | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT | Total |
|---|---|---|---|
| Mean | 41.6 ± 12.0 | 41.7 ± 11.7 | 41.6 ± 11.9 |
| Sex: Female, Male(Participants) | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT | Total |
|---|---|---|---|
| Female | 153 | 152 | 305 |
| Male | 98 | 90 | 188 |
| Race (NIH/OMB)(Participants) | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 251 | 242 | 493 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Foster 100/6µg NEXThaler - ITT | Foster 100/6µg pMDI - ITT | Total |
|---|---|---|---|
| China | 251 | 242 | 493 |
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