Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma. (FORTUNE)

A 12-week, Multicenter, Randomized, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster 100/6mg NEXThaler, 2 Inhalations b.i.d, Versus Foster 100/6mg pMDI, 2 Puffs b.i.d in Patients With Controlled Asthma.

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Foster 100/6µg NEXThaler; Drug: Foster 100/6µg pMDI

Detailed Description

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:

• Pre-Screening Phase (Visit 0): Conducted within a maximum of 7 days before the screening visit (Visit 1), this phase provided patients with study details, obtained informed consent, and outlined medication restrictions.
• Screening and Run-in Phase (Visit 1, Week -4 to Visit 2, Week -2): Patients underwent eligibility assessments and transitioned into a 4-week open-label run-in period with Foster® pMDI 100/6 µg (400/24 µg/day) to establish baseline parameters.
• Randomisation Phase (Visit 3, Week 0): Eligible patients were randomised in a 1:1 ratio to receive either Foster® NEXThaler® 100/6 µg 2 inhalations bid (for a total daily dose of 400/24 µg/day) or Foster® pMDI 100/6 µg, 2 puffs bid (for a total daily dose of 400/24 µg/day) for 12 weeks. The allocation was managed via an Interactive Web Response System (IWRS) to ensure balanced treatment groups.
• Investigational Phase (Treatment Period: Weeks 0-12): Patients attended scheduled visits at Weeks 2, 4, 6, 8, 10, and 12 to monitor efficacy and safety.

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.

• Follow-Up Phase: A safety follow-up phone call was conducted 7-10 days after the final visit (Week 12) or early termination to assess any unresolved adverse events (AEs) or new concomitant medications.

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.

• Study Type: Interventional
• Enrollment (Actual): 494
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100144
    • Chiesi Clinical Trial site 15672
  • Beijing, China
    • Chiesi clinical Trial site 15636
  • Chongqing, China
    • Chiesi Clinical Trial site 15638
  • Guizhou, China
    • Chiesi Clinical Trial site 15670
  • Hebei, China
    • Chiesi clinical Trial Site 15611
  • Jilin City, China
    • Chiesi Clinical trial site 15660
  • Shanghai, China
    • Chiesi Clinical Trial site 15628
  • Shanghai, China
    • Chiesi clinical trial site 15637
  • Shenzhen, China
    • Chiesi Clinical Trial site 15666
  • Sichuan, China
    • Chiesi clinical Trial site 15633
  • Ürümqi, China, 830054
    • Chiesi Clinical Trial site 15669
  • Anhui
    • Hefei, Anhui, China
      • Chiesi Clinical Trial site 15641
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Chiesi Clinical Trial site 15682
    • Beijing, Beijing Municipality, China, 101100
      • Chiesi Clinical Trial site 15663
  • Guangdong
    • Foshan, Guangdong, China
      • Chiesi Clinical Trial site 15662
    • Guangzhou, Guangdong, China, 5100150
      • Chiesi Clinical Trial site 15671
    • Guangzhou, Guangdong, China, 510120
      • Chiesi Clinical Trial site 15610
    • Guangzhou, Guangdong, China
      • Chiesi clinical Trial site 15656
    • Guangzhou, Guangdong, China
      • Chiesi Clinical Trial site 15668
    • Huizhou, Guangdong, China, 516001
      • Chiesi Clinical Trial site 15677
    • Shenzhen, Guangdong, China, 518052
      • Chiesi Clinical Trial site 15683
    • Shenzhen, Guangdong, China
      • Chiesi Clinical Trial site 15608
    • Zhanjiang, Guangdong, China, 524001
      • Chiesi Clinical Trial site 15607
  • Guangzhou
    • Guangzhou, Guangzhou, China, 511400
      • Chiesi Clinical Trial site 15610
  • Hainan
    • Haikou, Hainan, China, 570208
      • Chiesi Clinical Trial site 15673
  • Heilongjiang
    • Qiqihar, Heilongjiang, China, 161002
      • Chiesi Clinical Trial site 15678
  • Henan
    • Xinxiang, Henan, China, 453000
      • Chiesi Clinical Trial site 15681
    • Zhengzhou, Henan, China, 450003
      • Chiesi Clinical Trial site 15679
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Chiesi Clinical Trial site 15614
    • Wuhan, Hubei, China
      • Chiesi Clinical Trial site 15661
  • Hunan
    • Hengyang, Hunan, China, 421000
      • Chiesi Clinical Trial site 15675
  • Jiangsu
    • Changzhou, Jiangsu, China, 213164
      • Chiesi Clinical Trial site 15643
  • Jiangxi
    • Pingxiang, Jiangxi, China, 337055
      • Chiesi Clinical Trial site 15674
  • Jilin
    • Jilin City, Jilin, China, 132011
      • Chiesi Clinical Trial site 15676
  • Liaoning
    • Shenyang, Liaoning, China
      • Chiesi clinical Trial site 15621
  • Nanchang
    • Nanchang, Nanchang, China, 330006
      • Chiesi clinical Trial site 15619
  • Neimenggu
    • Hohhot, Neimenggu, China, 010017
      • Chiesi Clinical Trial site 15650
    • Hohhot, Neimenggu, China
      • Chiesi clinical Trial site 15659
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Chiesi Clinical Trial site 15630
    • Shanghai, Shanghai Municipality, China, 200050
      • Chiesi Clinical Trial site 15664
    • Shanghai, Shanghai Municipality, China, 201100
      • Chiesi Clinical Trial site 15654
    • Shanghai, Shanghai Municipality, China
      • Chiesi Clinical Trial site 15630
    • Shanghai, Shanghai Municipality, China
      • Chiesi Clinical Trial site 15631
    • Shanghai, Shanghai Municipality, China
      • Chiesi Clinical Trial site 15665
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Chiesi Clinical Trial site 15625
  • Shijiazhuang
    • Shijiazhuang, Shijiazhuang, China, 050000
      • Chiesi clinical Trial Site 15611
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Chiesi clinical Trial site 15633
    • Chongqing, Sichuan, China, 408499
      • Chiesi Clinical Trial site 15680
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Chiesi Clinical Trial site 15642
    • Tianjin, Tianjin Municipality, China, 300350
      • Chiesi Clinical Trial site 15634
  • Xian
    • Xi'an, Xian, China, 710061
      • Chiesi Clinical Trial site 15626

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female outpatients, Chinese ethnicity aged ≥18 years, who signed an ICF prior to initiation of any study-related procedure;

2. 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);

3. 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:

   • At V1 (Week -4), the test could have been repeated once before V2 or at V2 (Week -2);
   • At randomisation visit (V3, Week 0), the test could have been repeated once within 2 days after this visit;
4. ACQ-6 score <0.75 (checked at V1 [Week -4] and at the randomisation visit [V3, Week 0]);
5. Patients on previous regular treatment at a stable dose for at least 1 month prior to the screening visit (V1, Week -4) with either medium daily dose of ICS monotherapy (e.g. BDP-chlorofluorocarbons [CFC] >500-1000 µg/day or equivalent dose) or high daily dose of ICS monotherapy (e.g. BDP-CFC >1000 µg/day or equivalent dose) or low daily dose of ICS (e.g. BDP-CFC ≥200-500 µg/day or equivalent dose)/LABA free/fixed combination or medium daily dose of ICS (e.g. BDP-CFC >500-1000 µg/day or equivalent dose)/LABA free/fixed combination;
6. A cooperative attitude and ability to be trained to the proper use of DPI and pMDI inhalers and an electronic peak flow meter (checked at the screening visit [V1, Week -4] and at the randomisation visit [V3, Week 0]);
7. At least seven valid pre-dose morning PEF measurements in the last 14 days of the run-in period were necessary (checked at the randomisation visit [V3, Week 0]).

Exclusion Criteria:

1. 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;
   • Sexual abstinence; Reliable contraception had to be maintained throughout the study. Any postmenopausal women (physiologic menopause defined as "12 consecutive months of amenorrhoea without an alternative medical cause") or women permanently sterilised (e.g. bilateral oophorectomy, hysterectomy or bilateral salpingectomy) could be enrolled in the study.

   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);

2. Intermittent asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitiser;
3. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in an intensive care unit);
4. Diagnosis of chronic obstructive pulmonary disease as defined by the current global initiative for chronic obstructive lung disease (GOLD) guidelines updated 2016 [18];
5. Current smokers or ex-smokers with total cumulative exposure equal or more than 10 pack-years or having stopped smoking 1 year or less prior to screening (V1, Week -4);
6. Severe asthma exacerbation leading to intake of systemic corticosteroids (≥10 days) within 1 month prior to inclusion or moderate/severe asthma exacerbation (according to international guidelines updated 2018 [GINA] [1]) during the run-in period (checked at the screening visit [V1, Week -4] and at the randomisation visit [V3, Week 0]);
7. Lower respiratory tract infections (e.g. pneumonia) affecting the patient's asthma within 1 month prior to inclusion;
8. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease;
9. Diagnosis of restrictive lung disease;
10. Patients treated with oral or parenteral corticosteroids in the previous 2 months before V1 (Week -4; 3 months for parenteral depot corticosteroids);
11. Intolerance or contra-indication to treatment with β2-agonists and/or ICS or allergy to any component of the study treatments;
12. Having received an investigational medication within 2 months before screening (V1, Week -4);
13. Patients who had a clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition (e.g. major surgery) that might have, in the judgment of the Investigator, represented for the patients an undue risk or that could have compromised the results or interpretation of the study;
14. History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias;
15. Clinically relevant laboratory abnormalities such as (but not limited to) hypokalaemia (<3.5 mEq/L), that might have compromised patient's safety or compliance, interfered with evaluation, or precluded completion of the study, in the judgment of the Investigator. Patients with uncontrolled diabetes including patients with a history of fasting plasma glucose levels consistently out of the normal range (>140 mg/dL) or HbA1C >8%;
16. Patients who had an abnormal 12-lead ECG (i.e. QRS interval [QRS] >120 ms and/or PR interval [PR] >210 ms and/or HR <45 beats per minute [bpm] and/or HR >110 bpm and/or Fridericia-corrected QT interval [QTcF] >450 ms for males or QTcF >470 ms for females) or 12-lead ECG evaluated as abnormal clinically significant (CS) by the Investigator, at screening (V1, Week -4);
17. Patients who had a concomitant disease of poor prognosis (e.g. cancer);
18. Patients treated with monoclonal antibodies (e.g. anti-immunoglobulin E [anti-IgE] antibodies);
19. Patients treated with non-potassium sparing diuretics (unless administered at a fixed dose combination with a potassium conserving medication), non-selective β1-blocking medications, quinidine, quinidine-like antiarrhythmics or any medication with a corrected QT interval (QTc) prolongation potential, or a history of QTc prolongation;
20. Patients treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants, unless already taken at stable doses in the month before screening (V1, Week -4) and without any safety concern;
21. Patients who were receiving therapy that could interact with steroids, such as enzyme inhibitors (macrolides, antifungal therapy [not topical]) or inducers (anticonvulsants, rifampicin);
22. Inability to comply with study procedures or with study treatment intake.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Foster 100/6µg NEXThaler; 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; A fixed combination of beclometasone dipropionate 100 µg and formoterol fumarate 6 µg per actuation, delivered via a breath-actuated dry powder inhaler (DPI).; Other Names: beclometasone dipropionate (BDP) 100 µg / formoterol fumarate (FF) 6 µg NEXThealer
Active Comparator: Foster 100/6µg pMDI; 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 pressurized metered-dose inhaler (pMDI) with HFA_134a propellant.; Other Names: beclometasone dipropionate (BDP) 100µg / formoterol fumarate (FF) 6µg pMDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline (Week 0, Visit 3) and Week 12 (EoT)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	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; Mild: symptoms not causing awakening; Moderate: discomfort causing awakenings; 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.	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; Mild: symptoms not causing awakening; Moderate: discomfort causing awakenings; 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.	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.	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.	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.	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.	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 .	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.	From Week 0 (Visit 3, Randomization) to Week 12 (Visit 9, EoT)

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Jinping MD Zheng, The First Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

General Publications

• Zheng J, Zhang J, Fu X, Lin C, Zhang X, Mei X, Corradi M, Cappellini G, Calabro E, Zhu C, Topole E. Comparison of extrafine beclomethasone dipropionate/formoterol fumarate dry powder inhaler and pressurized metered-dose inhaler in Chinese patients with asthma: the FORTUNE study. J Asthma. 2024 Apr;61(4):360-367. doi: 10.1080/02770903.2023.2272816. Epub 2023 Nov 1.

Helpful Links

• Lay Summary of clinical trial results is available both in English and Chinese on the Chiesi Group web-site, along with a copy of the CSR synopsis.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): December 28, 2021
• Study Completion (Actual): December 28, 2021

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Peek Expiratory Flow (PEF) Lung function tests; Foster® NEXThaler®; Foster® pMDI
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Organic Chemicals; Therapeutics; Polycyclic Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Patient Care; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Alcohols; Pregnadienetriols; Amino Alcohols; Ethanolamines; Steroids, Chlorinated; Formoterol Fumarate; Beclomethasone; Foster Home Care; alpha-ketoisovalerate dehydrogenase phosphatase
• Other Study ID Numbers: CCD-01535BA0-01; CTR20170917 (Other Identifier: http://www.chinadrugtrials.org.cn/)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No