A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid (FORCE2)

September 2, 2025 updated by: Chiesi Farmaceutici S.p.A.

A 12 Week, Randomized, Double-blind, Multicenter, Active Controlled, 2-Arm Parallel Group Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose (Fixed Combination of Extrafine Beclomethasone Dipropionate Plus Formoterol Fumarate) Compared to CHF 718 pMDI 800µg Total Daily Dose (Extrafine Beclomethasone Dipropionate) in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid

Compare the superiority of CHF 1535 versus CHF 718 in subjects with asthma who are on medium or high dose inhaled corticosteroids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a phase III, multicenter, randomized, double-blind active controlled 2-arm parallel group to compare superiority of CHF 1535 pressurised metered dose inhaler (pMDI) compared with CHF 718 pMDI, in subjects with asthma on medium or high dose inhaled corticosteroids, with regard to change from baseline in forced expiratory volume in the first second (FEV1) Area under the Curve Calculated Between Time 0 and 12 Hours (AUC0-12h) at Week 12.

After screening, eligible subjects entered a 2-week run-in period using CHF 718 (BDP) pMDI 100µg, followed by a 12-week double-blind, treatment period. Screened subjects who were on a medium dose inhaled corticosteroid (ICS) or medium dose ICS-long-acting β2-adrenergic receptor agonists (LABA) prior to the study, received CHF 718 pMDI 100µg 2 inhalations twice daily (BID) i.e. total daily dose (TDD) 400µg) during the 2-week run in period. Screened subjects who were on a high dose ICS prior to the study received CHF 718 pMDI 100µg 4 inhalations BID (TDD 800µg) during the 2-week run in period.

Following the run-in period, eligible subjects were randomized to one of two study drug arms (using a 1:1 allocation ratio) for 12 weeks. A total of 6 clinic visits (V), (V0-V5) and a follow-up call (V6) were performed during the study.

During the study, daily symptoms, rescue medication use, and compliance with the study drug were recorded via a subject-specific electronic diary (eDiary). Concomitant medications and adverse events (AEs) were assessed and recorded throughout the study. Vital signs measurements, physical exam, 12-lead electrocardiogram (ECG), peak expiratory flow (PEF), and spirometry measurements, including serial spirometry were performed and recorded. Symptoms were assessed using disease specific questionnaires. Routine hematology, blood chemistry, and urine pregnancy testing were performed before enrolment and at the end of study.

CHF 1535 pMDI = 200/6 μg pressurised metered dose inhaler (fixed combination of extrafine beclomethasone dipropionate [BDP] plus formoterol fumarate [FF]).

CHF 718 pMDI = 100 μg pressurised metered dose inhaler (extrafine beclomethasone dipropionate [BDP]).

Study Type

Interventional

Enrollment (Actual)

1377

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Chiesi Clinical Trial Site 840858
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chiesi Clinical Trial Site 840895
    • California
      • Encinitas, California, United States, 92024
        • Chiesi Clinical Trial Site 840856
      • Huntington Beach, California, United States, 92647
        • Chiesi Clinical Trial Site 840843
      • Huntington Beach, California, United States, 92647
        • Chiesi Clinical Trial Site 840860
      • Long Beach, California, United States, 90805
        • Chiesi Clinical Trial Site 840896
      • Los Angeles, California, United States, 90025
        • Chiesi Clinical Trial Site 840883
      • Los Angeles, California, United States, 90048
        • Chiesi Clinical Trial Site 840810
      • Newport Beach, California, United States, 92663
        • Chiesi Clinical Trial Site 840869
      • North Hollywood, California, United States, 91606
        • Chiesi Clinical Trial Site 840890
      • Northridge, California, United States, 91324
        • Chiesi Clinical Trial Site 840808
      • Pomona, California, United States, 91768
        • Chiesi Clinical Trial Site 840879
      • Sacramento, California, United States, 95823
        • Chiesi Clinical Trial Site 840868
      • San Diego, California, United States, 92120
        • Chiesi Clinical Trial Site 840849
      • San Diego, California, United States, 92123
        • Chiesi Clinical Trial Site 840877
      • San Jose, California, United States, 95117
        • Chiesi Clinical Trial Site 840861
      • Westminster, California, United States, 92683
        • Chiesi Clinical Trial Site 840881
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Chiesi Clinical Trial Site 840873
      • Denver, Colorado, United States, 80230
        • Chiesi Clinical Trial Site 840800
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Chiesi Clinical Trial Site 840820
      • Cutler Bay, Florida, United States, 33189
        • Chiesi Clinical Trial Site 840841
      • Greenacres City, Florida, United States, 33467
        • Chiesi Clinical Trial Site 840817
      • Hialeah, Florida, United States, 33012
        • Chiesi Clinical Trial Site 840822
      • Hialeah, Florida, United States, 33015
        • Chiesi Clinical Trial Site 840838
      • Kissimmee, Florida, United States, 34746
        • Chiesi Clinical Trial Site 840864
      • Miami, Florida, United States, 33125
        • Chiesi Clinical Trial Site 840814
      • Miami, Florida, United States, 33126
        • Chiesi Clinical Trial Site 840819
      • Miami, Florida, United States, 33126
        • Chiesi Clinical Trial Site 840875
      • Miami, Florida, United States, 33134
        • Chiesi Clinical Trial Site 840887
      • Miami, Florida, United States, 33136
        • Chiesi Clinical Trial Site 840821
      • Miami, Florida, United States, 33155
        • Chiesi Clinical Trial Site 840829
      • Miami, Florida, United States, 33165
        • Chiesi Clinical Trial Site 840828
      • Miami, Florida, United States, 33172
        • Chiesi Clinical Trial Site 840847
      • Miami, Florida, United States, 33174
        • Chiesi Clinical Trial Site 840818
      • Miami, Florida, United States, 33176
        • Chiesi Clinical Trial Site 840802
      • Miami, Florida, United States, 33184
        • Chiesi Clinical Trial Site 840835
      • Miami, Florida, United States, 33185
        • Chiesi Clinical Trial Site 840806
      • Miami, Florida, United States, 33186
        • Chiesi Clinical Trial Site 840855
      • Miami Gardens, Florida, United States, 33014
        • Chiesi Clinical Trial Site 840809
      • Miami Lakes, Florida, United States, 33014
        • Chiesi Clinical Trial Site 840863
      • Miami Lakes, Florida, United States, 33014
        • Chiesi Clinical Trial Site 840865
      • Miami Springs, Florida, United States, 33166
        • Chiesi Clinical Trial Site 840831
      • Palmetto Bay, Florida, United States, 33157
        • Chiesi Clinical Trial Site 840839
      • Pembroke Pines, Florida, United States, 33024
        • Chiesi Clinical Trial Site 840840
      • Pembroke Pines, Florida, United States, 33029
        • Chiesi Clinical Trial Site 840827
      • Port Saint Lucie, Florida, United States, 34952
        • Chiesi Clinical Trial Site 840811
      • St. Petersburg, Florida, United States, 33707
        • Chiesi Clinical Trial Site 840889
      • St. Petersburg, Florida, United States, 33709
        • Chiesi Clinical Trial Site 840834
      • St. Petersburg, Florida, United States, 33713
        • Chiesi Clinical Trial Site 840880
      • Tallahassee, Florida, United States, 32308
        • Chiesi Clinical Trial Site 840807
    • Georgia
      • Adairsville, Georgia, United States, 30103
        • Chiesi Clinical Trial Site 840871
    • Maryland
      • White Marsh, Maryland, United States, 21162
        • Chiesi Clinical Trial Site 840824
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Chiesi Clinical Trial Site 840826
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Chiesi Clinical Trial Site 840859
      • Saint Charles, Missouri, United States, 63301
        • Chiesi Clinical Trial Site 840888
      • St Louis, Missouri, United States, 63141
        • Chiesi Clinical Trial Site 840846
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Chiesi Clinical Trial Site 840867
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Chiesi Clinical Trial Site 840897
      • North Las Vegas, Nevada, United States, 89030
        • Chiesi Clinical Trial Site 840872
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Chiesi Clinical Trial Site 840836
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Chiesi Clinical Trial Site 840851
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Chiesi Clinical Trial Site 840899
      • Raleigh, North Carolina, United States, 27607
        • Chiesi Clinical Trial Site 840852
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Chiesi Clinical Trial Site 840866
      • Tulsa, Oklahoma, United States, 74133
        • Chiesi Clinical Trial Site 840878
    • Oregon
      • Grants Pass, Oregon, United States, 97527
        • Chiesi Clinical Trial Site 840884
      • Medford, Oregon, United States, 97504
        • Chiesi Clinical Trial Site 840830
      • Portland, Oregon, United States, 97202
        • Chiesi Clinical Trial Site 840853
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Chiesi Clinical Trial Site 840885
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Chiesi Clinical Trial Site 840892
      • Columbia, South Carolina, United States, 29204
        • Chiesi Clinical Trial Site 840844
      • Greenville, South Carolina, United States, 29615
        • Chiesi Clinical Trial Site 840850
      • Rock Hill, South Carolina, United States, 29732
        • Chiesi Clinical Trial Site 840894
      • Spartanburg, South Carolina, United States, 29303
        • Chiesi Clinical Trial Site 840891
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Chiesi Clinical Trial Site 840812
    • Texas
      • Baytown, Texas, United States, 77521
        • Chiesi Clinical Trial Site 840815
      • Boerne, Texas, United States, 78006
        • Chiesi Clinical Trial Site 840874
      • Carrollton, Texas, United States, 75007
        • Chiesi Clinical Trial Site 840845
      • Dallas, Texas, United States, 75225
        • Chiesi Clinical Trial Site 840876
      • El Paso, Texas, United States, 79903
        • Chiesi Clinical Trial Site 840803
      • Houston, Texas, United States, 77094
        • Chiesi Clinical Trial Site 840833
      • McKinney, Texas, United States, 75069
        • Chiesi Clinical Trial Site 840862
      • McKinney, Texas, United States, 75071
        • Chiesi Clinical Trial Site 840816
      • San Antonio, Texas, United States, 78207
        • Chiesi Clinical Trial Site 840842
      • San Antonio, Texas, United States, 78215
        • Chiesi Clinical Trial Site 840857
      • San Antonio, Texas, United States, 78258
        • Chiesi Clinical Trial Site 840823
      • Sugar Land, Texas, United States, 77479
        • Chiesi Clinical Trial Site 840801
    • Utah
      • Murray, Utah, United States, 84107
        • Chiesi Clinical Trial Site 840893
      • Riverton, Utah, United States, 84065
        • Chiesi Clinical Trial Site 840837
    • Washington
      • Bellingham, Washington, United States, 98225
        • Chiesi Clinical Trial Site 840882
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Chiesi Clinical Trial Site 840870

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (IC):

  1. Informed consent: A signed and dated written informed consent obtained prior to any study-related procedures.
  2. Sex and age: Male or female aged ≥18 and ≤75 years.
  3. Diagnosis of asthma: A documented history of asthma for at least 1 year, with onset before age 40
  4. Stable asthma therapy: Use of medium-dose ICS with or without a LABA or high-dose ICS alone for 3 months (at a stable dose for at least 4 weeks prior to screening).
  5. Lung function: Subjects with a pre-bronchodilator FEV1 ≥40% and ≤85% of predicted, after appropriate washout from bronchodilators, at the screening and randomization visits. In addition, the absolute value of the first pre-dose FEV1 at randomization (V2) must be at least 80% of the pre-bronchodilator value attained at screening.

  6. Reversibility post-bronchodilator: Subjects with a positive reversibility to bronchodilator at screening, defined as an increase in FEV1 > 12% and > 200mL compared to baseline within 30 minutes after 4 inhalations of albuterol hydrofluoroalkane (HFA) pMDI 90µg/actuation.

    Note for IC#5 and IC#6: In case the reversibility and/or quality threshold is not met at screening, the test can be performed once before randomization.

  7. Female subjects:

    a. Women of childbearing potential (WOCBP) fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signing of the informed consent form and until the follow-up contact or ii. WOCBP with non-fertile male partners (contraception is not required in this case).

    b. Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile as per definitions given in Appendix 2). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges).

  8. Cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary/peak flow meter.

Exclusion Criteria:

  1. Pregnancy or lactation: where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive pregnancy test (serum and urine pregnancy test to be performed at screening visit and urine pregnancy test to be performed prior to randomization).
  2. Poor compliance with run-in medication or eDiary completion <50% before randomization.
  3. History of "at risk" asthma: History of near-fatal asthma or of a past hospitalization for asthma in intensive care unit which, in the judgement of the investigator, may place the subject at undue risk.
  4. Recent asthma exacerbation: Hospitalization, emergency room admission or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to screening visit or during the run-in period.
  5. Unresolved respiratory tract infection (RTI) in the 4 weeks prior to the screening visit or during run-in period. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 8 weeks or complications from this disease, which have not resolved within 14 days prior to screening.
  6. Unstable ICS dose during the 4 weeks prior to screening visit, including any change in dose, schedule, or formulation.
  7. Use of systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks before screening.
  8. Respiratory disorders other than asthma: History of a diagnosis of cystic fibrosis, bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD), (as defined by the current Global Initiative for Chronic Obstructive Lung Disease [GOLD] Report), alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with study evaluations.
  9. Smoking status: Current smokers or ex-smokers with total cumulative exposure equal to or more than 10 pack-years or having stopped smoking within one year prior to screening visit.
  10. E-cigarette status: Current e-cigarettes users at the time of the screening visit.
  11. Cannabis usage: Current use of inhaled or oral cannabis products (e.g. marijuana).
  12. Substance abuse: Subjects with a history of alcohol or substance/drug abuse within 12 months prior to screening.
  13. Cardiovascular diseases: Subjects who have clinically significant cardiovascular condition such as, but not limited to, unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV heart failure, acute ischemic heart disease within one year prior to study entry, known history of atrial fibrillation or history of sustained and non-sustained cardiac arrhythmias diagnosed within the last 6 months prior to screening, not controlled with a rate control strategy. Note: Subjects with Permanent Atrial Fibrillation (for at least 6 months) with a resting ventricular rate <100/min, controlled with a rate control strategy (i.e., selective β-blocker, calcium channel blocker, pacemaker placement, digoxin, or ablation therapy) can be considered for the enrollment.
  14. ECG criteria: An abnormal and clinically significant 12-lead electrocardiogram (ECG) which may impact the safety of the subject according to Investigator's judgement. In terms of the QTcF, subjects with QTcF >450ms for males or QTcF >470ms for females at screening or at randomization visits (criterion not applicable for subject with pacemaker or permanent atrial fibrillation).
  15. Other medical conditions: Other active severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  16. Vaccination: Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period.
  17. Subjects' wellbeing: Subjects mentally or legally incapacitated, including but not limited to subjects who are institutionalized or incarcerated.
  18. Hypersensitivity: Subjects with known intolerance, hypersensitivity or contraindication to treatment with ß2-agonists, ICS, or propellant gases/excipients.
  19. Surgery: Subjects with major surgery in the 3 months prior to the screening visit or planned surgery during the study.
  20. Additional treatment: Subjects treated with non-potassium sparing diuretics (unless administered as a fixed-dose combination with a potassium conserving drug or changed to potassium sparing before the screening), non-selective beta-blocking drugs, quinidine, quinidine-like anti-arrhythmic, or any medication with a QTc prolongation potential or a history of QTc prolongation.
  21. Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants.
  22. Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-immunoglobulin E (IgE), anti-IL5 or other monoclonal or polyclonal antibodies within 12 weeks prior to screening.
  23. Subjects who are receiving any therapy that could interfere with the study drugs according to investigator's opinion.
  24. Participating in other investigational trial: Subjects who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.
  25. Spacer: The need to use a spacer for correct self-administration of a pMDI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHF 1535 pMDI
CHF 1535 pMDI 800/24µg TDD
Drug: Beclomethasone Dipropionate/Formoterol Fumarate
Available in pressurized inhalation solution BDP/FF 200/6 µg
Other Names:
  • BDP/FF
Active Comparator: CHF 718 pMDI
CHF 718 pMDI 800µg TDD
Drug: Beclomethasone Dipropionate
Available in pressurized inhalation solution BDP 100 µg
Other Names:
  • BDP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1_Change From Baseline in FEV1 AUC0-12h Normalised by Time at Week 12
Time Frame: Baseline (pre-dose on Week 0) and Week 12.

The pre-dose FEV1 at baseline (i.e. pre-dose on Week 0 [Visit 2]) and the FEV1 AUC0-12h normalised by time at Week 12 (Visit 5) are presented by treatment group in the ITT population, as change from baseline.

AUC0=12h Area under the curve calculated between time 0 and 12 hours
Baseline (pre-dose on Week 0) and Week 12.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2_Change From Baseline in Peak FEV1 Within the First 3 Hours Post-dose at Week 12
Time Frame: Baseline (pre-dose on Week 0) and Week 12.

The peak FEV1 at baseline (i.e. pre-dose on Week 0 [V2]) and the peak FEV1 within the first 3 hours post-dose at Week 12 (V5) are presented by treatment group in the ITT population, as change from baseline.

FEV1=Forced Expiratory Volume in the First Second
Baseline (pre-dose on Week 0) and Week 12.
3_Change From Baseline in FEV1 AUC0-12h Normalised by Time at Week 0
Time Frame: Baseline (pre-dose on Week 0) and Week 12.
The pre-dose FEV1 at baseline (i.e. pre-dose on Week 0 [V2]) and the FEV1 AUC0-12h normalised by time at Week 0 (V2, post-dose) are presented by treatment group in the ITT population, as change from baseline.
Baseline (pre-dose on Week 0) and Week 12.
4_Change From Baseline in Peak FEV1 Within the First 3 Hours Post-dose at Week 0
Time Frame: Baseline (pre-dose on Week 0) and 3 h post dose on Week 0.

The peak FEV1 at baseline (i.e. pre-dose on Week 0 [V2]) and the peak FEV1 within the first 3 hours post-dose at Week 0 (V2, post-dose) are presented by treatment group in the ITT population, as change from baseline.

FEV1=Forced Expiratory Volume in the First Second
Baseline (pre-dose on Week 0) and 3 h post dose on Week 0.
5_Change From Baseline in Trough FEV1 at Week 12
Time Frame: Baseline (pre-dose on Week 0) and Week 12.

The trough FEV1 at baseline (i.e. pre-dose on Week 0 [V2]), the trough FEV1 at Week 12 (V5) and the change from baseline in trough FEV1 at Week 12 (V5) are presented by treatment group in the ITT population, as change from baseline.

FEV1=Forced Expiratory Volume in the First Second
Baseline (pre-dose on Week 0) and Week 12.
6_Change From Baseline in Pre-dose Morning FEV1 at Weeks 4, 8 and 12
Time Frame: Baseline (pre-dose on Week 0) and Week 4, Week 8, Week 12.

The pre-dose MORNING FEV1 at baseline (i.e. pre-dose on Week 0 [V2]) and the pre-dose morning FEV1 at Week 4 (V3), Week 8 (V4) and Week 12 (V5) are presented by treatment group in the ITT population, as change from baseline.

FEV1=Forced Expiratory Volume in the First Second
Baseline (pre-dose on Week 0) and Week 4, Week 8, Week 12.
7_Proportion of Pre-dose Morning FEV1 Responders at Weeks 4, 8 and 12
Time Frame: Baseline (pre-dose on Week 0) and Week 4, Week 8, Week 12.

The proportion of pre-dose MORNING FEV1 responders at Week 4 (V3), Week 8 (V4) and Week 12 (V5) are presented by treatment group in the ITT population. The proportion of subjects classified as pre-dose morning FEV1 responders (i.e. those subjects who had change from baseline in pre-dose morning FEV1 ≥100 mL).

FEV1=Forced Expiratory Volume in the First Second
Baseline (pre-dose on Week 0) and Week 4, Week 8, Week 12.
8_Proportion of Trough FEV1 Responders at Week 12
Time Frame: Baseline (pre-dose on Week 0) and Week 4, Week 8, Week 12.

The proportion of trough FEV1 responders at Week 12 (V5) are presented by treatment group in the ITT population.

The proportion of subjects classified as trough FEV1 responders (i.e. those subjects who had change from baseline in trough FEV1 ≥100 mL).

FEV1=Forced Expiratory Volume in the First Second
Baseline (pre-dose on Week 0) and Week 4, Week 8, Week 12.
9_Change From Baseline in Average Morning Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period
Time Frame: Baseline (Week 0) to Week 12.

The average MORNING PEF at baseline (i.e. average morning "Best PEF" values during the run-in period, over each inter-visit period and over the 12-week treatment period are presented by treatment group in the ITT population), as change from baseline.

PEF=Peak Expiratory Flow
Baseline (Week 0) to Week 12.
10_Change From Baseline in Average Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period
Time Frame: Baseline (Week 0) to Week 12.

The average EVENING PEF at baseline (i.e. average evening "Best PEF" values during the run-in period, see Section 9.7.1.4), over each inter-visit period and over the 12-week treatment period are presented by treatment group in the ITT population, as change from baseline.

PEF=Peak Expiratory Flow
Baseline (Week 0) to Week 12.
11_Change From Baseline in ACQ-7 Score and ACQ-5 Score at Week 12
Time Frame: Baseline (pre-dose on Week 0) and Week 12.

The ACQ-7 and ACQ-5 scores at baseline (i.e. pre-dose on Week 0 [V2]) and at Week 12 (V5) are presented by treatment group in the ITT population, as change from baseline; only patients who provided required data at baseline and at specified times are included in the calculation.

Asthma control was evaluated during the treatment period (Week 0 to Week 12 [V2-V5])/end of treatment (ET) if applicable, using ACQ-7; first 6 items refer to symptoms and rescue use in the previous 7 days. The 7th item, filled in by the clinical staff, was the FEV1 (% predicted) recorded at 15 min pre-dose, measured at each visit during the treatment period. ACQ-5 has 5 items on adequacy of asthma control.

ACQ-7:

Assess asthma symptoms over last 7 days (night-time awakenings due to symptoms, morning symptoms, activity limitation, shortness of breath, wheezing), average daily rescue medication use, and current FEV1 percent predicted. Score scale: 0=totally controlled; 6=severely uncontrolled.
Baseline (pre-dose on Week 0) and Week 12.
12_Change From Baseline in Percentage of Rescue Medication-free Days Over the 12-Week Treatment Period
Time Frame: Baseline (pre-dose on Week 0) and Week 12.
The percentage of rescue medication-free days at baseline (i.e. percentage of days during the run-in period with no rescue medication), over each inter-visit period and over the 12-week treatment period are presented by treatment group in the ITT population, as change from baseline.
Baseline (pre-dose on Week 0) and Week 12.
13_Change From Baseline in Percentage of Asthma Symptom-free Days Over the 12-Week Treatment Period
Time Frame: Baseline (pre-dose on Week 0) and Week 12.
The percentage of asthma symptom-free days at baseline (i.e. percentage of days during the run-in period with no asthma symptom, over each inter-visit period and over the 12-week treatment period are presented by treatment group in the ITT population, as change from baseline.
Baseline (pre-dose on Week 0) and Week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Steven F. Weinstein, M.D., Allergy and Asthma Specialists Medical Group and Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2022

Primary Completion (Actual)

June 24, 2024

Study Completion (Actual)

June 24, 2024

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLI-05993AB8-02

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

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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