AzTrials
AzTrials

AsthmaPhase 3FORCE2NCT05292586

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

A Phase 3 study testing Beclomethasone Dipropionate/Formoterol Fumarate and Beclomethasone Dipropionate in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 91 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
Beclomethasone Dipropionate/Formoterol Fumarate and Beclomethasone Dipropionate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,377 participants
Where
91 sitesUnited States
Study dates
31 Aug 2022to 24 Jun 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent: A signed and dated written informed consent obtained prior to any study-related procedures.
  • Sex and age: Male or female aged ≥18 and ≤75 years.
  • Diagnosis of asthma: A documented history of asthma for at least 1 year, with onset before age 40
  • 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).
  • 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.
  • 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.
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  • 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.
  • Female subjects:
  • 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).
  • 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).
  • Cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary/peak flow meter.

Who cannot join

  • 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).
  • Poor compliance with run-in medication or eDiary completion <50% before randomization.
  • 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.
  • 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.
  • 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.
  • Unstable ICS dose during the 4 weeks prior to screening visit, including any change in dose, schedule, or formulation.
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  • Use of systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks before screening.
  • 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.
  • 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.
  • E-cigarette status: Current e-cigarettes users at the time of the screening visit.
  • Cannabis usage: Current use of inhaled or oral cannabis products (e.g. marijuana).
  • Substance abuse: Subjects with a history of alcohol or substance/drug abuse within 12 months prior to screening.
  • 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.
  • 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).
  • 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.
  • Vaccination: Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period.
  • Subjects' wellbeing: Subjects mentally or legally incapacitated, including but not limited to subjects who are institutionalized or incarcerated.
  • Hypersensitivity: Subjects with known intolerance, hypersensitivity or contraindication to treatment with ß2-agonists, ICS, or propellant gases/excipients.
  • Surgery: Subjects with major surgery in the 3 months prior to the screening visit or planned surgery during the study.
  • 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.
  • Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants.
  • 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.
  • Subjects who are receiving any therapy that could interfere with the study drugs according to investigator's opinion.
  • 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.
  • Spacer: The need to use a spacer for correct self-administration of a pMDI.

Trial locations and contacts

91 sites in 1 country.

91 sites in 1 country

United States91 sites

  • Chiesi Clinical Trial Site 840871

    Adairsville, Georgia, 30103

  • Chiesi Clinical Trial Site 840851

    Albuquerque, New Mexico, 87108

  • Chiesi Clinical Trial Site 840892

    Anderson, South Carolina, 29621

  • Chiesi Clinical Trial Site 840815

    Baytown, Texas, 77521

  • Chiesi Clinical Trial Site 840867

    Bellevue, Nebraska, 68123

  • Chiesi Clinical Trial Site 840882

    Bellingham, Washington, 98225

  • Chiesi Clinical Trial Site 840874

    Boerne, Texas, 78006

  • Chiesi Clinical Trial Site 840836

    Brick, New Jersey, 08724

  • Chiesi Clinical Trial Site 840845

    Carrollton, Texas, 75007

  • Chiesi Clinical Trial Site 840895

    Chandler, Arizona, 85224

  • Chiesi Clinical Trial Site 840873

    Colorado Springs, Colorado, 80907

  • Chiesi Clinical Trial Site 840859

    Columbia, Missouri, 65203

  • Chiesi Clinical Trial Site 840844

    Columbia, South Carolina, 29204

  • Chiesi Clinical Trial Site 840820

    Coral Gables, Florida, 33134

  • Chiesi Clinical Trial Site 840841

    Cutler Bay, Florida, 33189

  • Chiesi Clinical Trial Site 840876

    Dallas, Texas, 75225

  • Chiesi Clinical Trial Site 840800

    Denver, Colorado, 80230

  • Chiesi Clinical Trial Site 840866

    Edmond, Oklahoma, 73034

  • Chiesi Clinical Trial Site 840803

    El Paso, Texas, 79903

  • Chiesi Clinical Trial Site 840856

    Encinitas, California, 92024

  • Chiesi Clinical Trial Site 840884

    Grants Pass, Oregon, 97527

  • Chiesi Clinical Trial Site 840817

    Greenacres City, Florida, 33467

  • Chiesi Clinical Trial Site 840870

    Greenfield, Wisconsin, 53228

  • Chiesi Clinical Trial Site 840850

    Greenville, South Carolina, 29615

  • Chiesi Clinical Trial Site 840897

    Henderson, Nevada, 89052

  • Chiesi Clinical Trial Site 840822

    Hialeah, Florida, 33012

  • Chiesi Clinical Trial Site 840838

    Hialeah, Florida, 33015

  • Chiesi Clinical Trial Site 840833

    Houston, Texas, 77094

  • Chiesi Clinical Trial Site 840843

    Huntington Beach, California, 92647

  • Chiesi Clinical Trial Site 840860

    Huntington Beach, California, 92647

  • Chiesi Clinical Trial Site 840864

    Kissimmee, Florida, 34746

  • Chiesi Clinical Trial Site 840812

    Knoxville, Tennessee, 37909

  • Chiesi Clinical Trial Site 840896

    Long Beach, California, 90805

  • Chiesi Clinical Trial Site 840883

    Los Angeles, California, 90025

  • Chiesi Clinical Trial Site 840810

    Los Angeles, California, 90048

  • Chiesi Clinical Trial Site 840862

    McKinney, Texas, 75069

  • Chiesi Clinical Trial Site 840816

    McKinney, Texas, 75071

  • Chiesi Clinical Trial Site 840830

    Medford, Oregon, 97504

  • Chiesi Clinical Trial Site 840814

    Miami, Florida, 33125

  • Chiesi Clinical Trial Site 840819

    Miami, Florida, 33126

  • Chiesi Clinical Trial Site 840875

    Miami, Florida, 33126

  • Chiesi Clinical Trial Site 840887

    Miami, Florida, 33134

  • Chiesi Clinical Trial Site 840821

    Miami, Florida, 33136

  • Chiesi Clinical Trial Site 840829

    Miami, Florida, 33155

  • Chiesi Clinical Trial Site 840828

    Miami, Florida, 33165

  • Chiesi Clinical Trial Site 840847

    Miami, Florida, 33172

  • Chiesi Clinical Trial Site 840818

    Miami, Florida, 33174

  • Chiesi Clinical Trial Site 840802

    Miami, Florida, 33176

  • Chiesi Clinical Trial Site 840835

    Miami, Florida, 33184

  • Chiesi Clinical Trial Site 840806

    Miami, Florida, 33185

  • Chiesi Clinical Trial Site 840855

    Miami, Florida, 33186

  • Chiesi Clinical Trial Site 840809

    Miami Gardens, Florida, 33014

  • Chiesi Clinical Trial Site 840863

    Miami Lakes, Florida, 33014

  • Chiesi Clinical Trial Site 840865

    Miami Lakes, Florida, 33014

  • Chiesi Clinical Trial Site 840831

    Miami Springs, Florida, 33166

  • Chiesi Clinical Trial Site 840858

    Mobile, Alabama, 36608

  • Chiesi Clinical Trial Site 840899

    Monroe, North Carolina, 28112

  • Chiesi Clinical Trial Site 840893

    Murray, Utah, 84107

  • Chiesi Clinical Trial Site 840869

    Newport Beach, California, 92663

  • Chiesi Clinical Trial Site 840826

    North Dartmouth, Massachusetts, 02747

  • Chiesi Clinical Trial Site 840890

    North Hollywood, California, 91606

  • Chiesi Clinical Trial Site 840872

    North Las Vegas, Nevada, 89030

  • Chiesi Clinical Trial Site 840808

    Northridge, California, 91324

  • Chiesi Clinical Trial Site 840839

    Palmetto Bay, Florida, 33157

  • Chiesi Clinical Trial Site 840840

    Pembroke Pines, Florida, 33024

  • Chiesi Clinical Trial Site 840827

    Pembroke Pines, Florida, 33029

  • Chiesi Clinical Trial Site 840879

    Pomona, California, 91768

  • Chiesi Clinical Trial Site 840811

    Port Saint Lucie, Florida, 34952

  • Chiesi Clinical Trial Site 840853

    Portland, Oregon, 97202

  • Chiesi Clinical Trial Site 840852

    Raleigh, North Carolina, 27607

  • Chiesi Clinical Trial Site 840837

    Riverton, Utah, 84065

  • Chiesi Clinical Trial Site 840894

    Rock Hill, South Carolina, 29732

  • Chiesi Clinical Trial Site 840868

    Sacramento, California, 95823

  • Chiesi Clinical Trial Site 840888

    Saint Charles, Missouri, 63301

  • Chiesi Clinical Trial Site 840842

    San Antonio, Texas, 78207

  • Chiesi Clinical Trial Site 840857

    San Antonio, Texas, 78215

  • Chiesi Clinical Trial Site 840823

    San Antonio, Texas, 78258

  • Chiesi Clinical Trial Site 840849

    San Diego, California, 92120

  • Chiesi Clinical Trial Site 840877

    San Diego, California, 92123

  • Chiesi Clinical Trial Site 840861

    San Jose, California, 95117

  • Chiesi Clinical Trial Site 840891

    Spartanburg, South Carolina, 29303

  • Chiesi Clinical Trial Site 840846

    St Louis, Missouri, 63141

  • Chiesi Clinical Trial Site 840889

    St. Petersburg, Florida, 33707

  • Chiesi Clinical Trial Site 840834

    St. Petersburg, Florida, 33709

  • Chiesi Clinical Trial Site 840880

    St. Petersburg, Florida, 33713

  • Chiesi Clinical Trial Site 840801

    Sugar Land, Texas, 77479

  • Chiesi Clinical Trial Site 840807

    Tallahassee, Florida, 32308

  • Chiesi Clinical Trial Site 840878

    Tulsa, Oklahoma, 74133

  • Chiesi Clinical Trial Site 840885

    Warwick, Rhode Island, 02886

  • Chiesi Clinical Trial Site 840881

    Westminster, California, 92683

  • Chiesi Clinical Trial Site 840824

    White Marsh, Maryland, 21162

Other trials in United States

About this study

Official title: 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.

Read the 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]).

Conditions
Asthma
Being tested
Beclomethasone Dipropionate/Formoterol Fumarate, Beclomethasone Dipropionate
Keywords
Asthma, Beclomethasone Dipropionate, Beclometasone dipropionate/Formoterol fumarate, Inhaled Corticosteroids, CHF 1535 pMDI, CHF 718 pMDI
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beclomethasone Dipropionate/Formoterol FumarateDrug

    Also called BDP/FF

    Available in pressurized inhalation solution BDP/FF 200/6 µg

  • Beclomethasone DipropionateDrug

    Also called BDP

    Available in pressurized inhalation solution BDP 100 µg

Study groups in NCT05292586
Study groupRoleWhat they receive
CHF 1535 pMDIExperimentalCHF 1535 pMDI 800/24µg TDD
Receives: Drug: Beclomethasone Dipropionate/Formoterol Fumarate
CHF 718 pMDIActive comparatorCHF 718 pMDI 800µg TDD
Receives: Drug: Beclomethasone Dipropionate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1_Change From Baseline in FEV1 AUC0-12h Normalised by Time at 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

    Measured: Baseline (pre-dose on Week 0) and Week 12.

Secondary outcomes (12)

  1. 2_Change From Baseline in Peak FEV1 Within the First 3 Hours Post-dose at 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

    Measured: Baseline (pre-dose on Week 0) and Week 12.

  2. 3_Change From Baseline in FEV1 AUC0-12h Normalised by Time at Week 0

    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.

    Measured: Baseline (pre-dose on Week 0) and Week 12.

  3. 4_Change From Baseline in Peak FEV1 Within the First 3 Hours Post-dose at 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

    Measured: Baseline (pre-dose on Week 0) and 3 h post dose on Week 0.

  4. 5_Change From Baseline in Trough FEV1 at 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

    Measured: Baseline (pre-dose on Week 0) and Week 12.

  5. 6_Change From Baseline in Pre-dose Morning FEV1 at Weeks 4, 8 and 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

    Measured: Baseline (pre-dose on Week 0) and Week 4, Week 8, Week 12.

  6. 7_Proportion of Pre-dose Morning FEV1 Responders at Weeks 4, 8 and 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

    Measured: Baseline (pre-dose on Week 0) and Week 4, Week 8, Week 12.

  7. 8_Proportion of Trough FEV1 Responders at 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

    Measured: Baseline (pre-dose on Week 0) and Week 4, Week 8, Week 12.

  8. 9_Change From Baseline in Average Morning Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period

    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

    Measured: Baseline (Week 0) to Week 12.

  9. 10_Change From Baseline in Average Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period

    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

    Measured: Baseline (Week 0) to Week 12.

  10. 11_Change From Baseline in ACQ-7 Score and ACQ-5 Score at 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.

    Measured: Baseline (pre-dose on Week 0) and Week 12.

  11. 12_Change From Baseline in Percentage of Rescue Medication-free Days Over the 12-Week Treatment Period

    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.

    Measured: Baseline (pre-dose on Week 0) and Week 12.

  12. 13_Change From Baseline in Percentage of Asthma Symptom-free Days Over the 12-Week Treatment Period

    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.

    Measured: Baseline (pre-dose on Week 0) and Week 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2022
  2. Study start31 Aug 2022
  3. Primary completion24 Jun 2024
  4. Study completion24 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,377 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05292586
Sponsor's protocol ID
CLI-05993AB8-02
Acronym
FORCE2
Status last verified
Jun 2026
First submitted
4 Mar 2022
Last updated
20 Jul 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.

Publications

  • Pelaia C, Crimi C, Vatrella A, Tinello C, Terracciano R, Pelaia G. Molecular Targets for Biological Therapies of Severe Asthma. Front Immunol. 2020 Nov 30;11:603312. doi: 10.3389/fimmu.2020.603312. eCollection 2020.

    PubMed 33329598

  • Roger JH, Bratton DJ, Mayer B, Abellan JJ, Keene ON. Treatment policy estimands for recurrent event data using data collected after cessation of randomised treatment. Pharm Stat. 2019 Jan;18(1):85-95. doi: 10.1002/pst.1910. Epub 2018 Nov 8.

    PubMed 30406948

  • Kardas G, Kuna P, Panek M. Biological Therapies of Severe Asthma and Their Possible Effects on Airway Remodeling. Front Immunol. 2020 Jun 18;11:1134. doi: 10.3389/fimmu.2020.01134. eCollection 2020.

    PubMed 32625205

  • Kippelen P, Anderson SD, Hallstrand TS. Mechanisms and Biomarkers of Exercise-Induced Bronchoconstriction. Immunol Allergy Clin North Am. 2018 May;38(2):165-182. doi: 10.1016/j.iac.2018.01.008.

    PubMed 29631728

  • Chau-Etchepare F, Hoerger JL, Kuhn BT, Zeki AA, Haczku A, Louie S, Kenyon NJ, Davis CE, Schivo M. Viruses and non-allergen environmental triggers in asthma. J Investig Med. 2019 Oct;67(7):1029-1041. doi: 10.1136/jim-2019-001000. Epub 2019 Jul 27.

    PubMed 31352362

  • GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.

    PubMed 33069326

  • Forno E, Celedon JC. Asthma and ethnic minorities: socioeconomic status and beyond. Curr Opin Allergy Clin Immunol. 2009 Apr;9(2):154-60. doi: 10.1097/aci.0b013e3283292207.

    PubMed 19326508

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Beclomethasone Dipropionate/Formoterol Fumarate and Beclomethasone Dipropionate in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 91 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05292586, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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