New combo inhaler shows promise for better asthma control in large trial

NCT ID NCT05292586

Disease control Sponsor: Chiesi Farmaceutici S.p.A. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study tested whether a combination inhaler containing both an anti-inflammatory steroid (beclomethasone) and a fast-acting bronchodilator (formoterol) works better than a steroid-only inhaler for adults with asthma. Over 1,300 participants on medium or high-dose steroids took either the combo or the steroid-only inhaler for 12 weeks. The main goal was to measure improvements in lung function over a 12-hour period after dosing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Beclomethasone dipropionate and formoterol fumarate combination inhaler
What this could lead to: If successful, this combination inhaler could offer better lung function and symptom control for people with asthma who already use medium or high-dose steroids.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. The improvement over steroid-only treatment may be small, and not everyone may benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,377 people

The number who actually took part.

Started

Aug 2022

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

Chiesi Clinical Trial Site 840800

Denver, Colorado, 80230, United States
Chiesi Clinical Trial Site 840801

Sugar Land, Texas, 77479, United States
Chiesi Clinical Trial Site 840802

Miami, Florida, 33176, United States
Chiesi Clinical Trial Site 840803

El Paso, Texas, 79903, United States
Chiesi Clinical Trial Site 840806

Miami, Florida, 33185, United States
Chiesi Clinical Trial Site 840807

Tallahassee, Florida, 32308, United States
Chiesi Clinical Trial Site 840808

Northridge, California, 91324, United States
Chiesi Clinical Trial Site 840809

Miami Gardens, Florida, 33014, United States
Chiesi Clinical Trial Site 840810

Los Angeles, California, 90048, United States
Chiesi Clinical Trial Site 840811

Port Saint Lucie, Florida, 34952, United States
Chiesi Clinical Trial Site 840812

Knoxville, Tennessee, 37909, United States
Chiesi Clinical Trial Site 840814

Miami, Florida, 33125, United States
Chiesi Clinical Trial Site 840815

Baytown, Texas, 77521, United States
Chiesi Clinical Trial Site 840816

McKinney, Texas, 75071, United States
Chiesi Clinical Trial Site 840817

Greenacres City, Florida, 33467, United States
Chiesi Clinical Trial Site 840818

Miami, Florida, 33174, United States
Chiesi Clinical Trial Site 840819

Miami, Florida, 33126, United States
Chiesi Clinical Trial Site 840820

Coral Gables, Florida, 33134, United States
Chiesi Clinical Trial Site 840821

Miami, Florida, 33136, United States
Chiesi Clinical Trial Site 840822

Hialeah, Florida, 33012, United States
Chiesi Clinical Trial Site 840823

San Antonio, Texas, 78258, United States
Chiesi Clinical Trial Site 840824

White Marsh, Maryland, 21162, United States
Chiesi Clinical Trial Site 840826

North Dartmouth, Massachusetts, 02747, United States
Chiesi Clinical Trial Site 840827

Pembroke Pines, Florida, 33029, United States
Chiesi Clinical Trial Site 840828

Miami, Florida, 33165, United States
Chiesi Clinical Trial Site 840829

Miami, Florida, 33155, United States
Chiesi Clinical Trial Site 840830

Medford, Oregon, 97504, United States
Chiesi Clinical Trial Site 840831

Miami Springs, Florida, 33166, United States
Chiesi Clinical Trial Site 840833

Houston, Texas, 77094, United States
Chiesi Clinical Trial Site 840834

St. Petersburg, Florida, 33709, United States
Chiesi Clinical Trial Site 840835

Miami, Florida, 33184, United States
Chiesi Clinical Trial Site 840836

Brick, New Jersey, 08724, United States
Chiesi Clinical Trial Site 840837

Riverton, Utah, 84065, United States
Chiesi Clinical Trial Site 840838

Hialeah, Florida, 33015, United States
Chiesi Clinical Trial Site 840839

Palmetto Bay, Florida, 33157, United States
Chiesi Clinical Trial Site 840840

Pembroke Pines, Florida, 33024, United States
Chiesi Clinical Trial Site 840841

Cutler Bay, Florida, 33189, United States
Chiesi Clinical Trial Site 840842

San Antonio, Texas, 78207, United States
Chiesi Clinical Trial Site 840843

Huntington Beach, California, 92647, United States
Chiesi Clinical Trial Site 840844

Columbia, South Carolina, 29204, United States
Chiesi Clinical Trial Site 840845

Carrollton, Texas, 75007, United States
Chiesi Clinical Trial Site 840846

St Louis, Missouri, 63141, United States
Chiesi Clinical Trial Site 840847

Miami, Florida, 33172, United States
Chiesi Clinical Trial Site 840849

San Diego, California, 92120, United States
Chiesi Clinical Trial Site 840850

Greenville, South Carolina, 29615, United States
Chiesi Clinical Trial Site 840851

Albuquerque, New Mexico, 87108, United States
Chiesi Clinical Trial Site 840852

Raleigh, North Carolina, 27607, United States
Chiesi Clinical Trial Site 840853

Portland, Oregon, 97202, United States
Chiesi Clinical Trial Site 840855

Miami, Florida, 33186, United States
Chiesi Clinical Trial Site 840856

Encinitas, California, 92024, United States
Chiesi Clinical Trial Site 840857

San Antonio, Texas, 78215, United States
Chiesi Clinical Trial Site 840858

Mobile, Alabama, 36608, United States
Chiesi Clinical Trial Site 840859

Columbia, Missouri, 65203, United States
Chiesi Clinical Trial Site 840860

Huntington Beach, California, 92647, United States
Chiesi Clinical Trial Site 840861

San Jose, California, 95117, United States
Chiesi Clinical Trial Site 840862

McKinney, Texas, 75069, United States
Chiesi Clinical Trial Site 840863

Miami Lakes, Florida, 33014, United States
Chiesi Clinical Trial Site 840864

Kissimmee, Florida, 34746, United States
Chiesi Clinical Trial Site 840865

Miami Lakes, Florida, 33014, United States
Chiesi Clinical Trial Site 840866

Edmond, Oklahoma, 73034, United States
Chiesi Clinical Trial Site 840867

Bellevue, Nebraska, 68123, United States
Chiesi Clinical Trial Site 840868

Sacramento, California, 95823, United States
Chiesi Clinical Trial Site 840869

Newport Beach, California, 92663, United States
Chiesi Clinical Trial Site 840870

Greenfield, Wisconsin, 53228, United States
Chiesi Clinical Trial Site 840871

Adairsville, Georgia, 30103, United States
Chiesi Clinical Trial Site 840872

North Las Vegas, Nevada, 89030, United States
Chiesi Clinical Trial Site 840873

Colorado Springs, Colorado, 80907, United States
Chiesi Clinical Trial Site 840874

Boerne, Texas, 78006, United States
Chiesi Clinical Trial Site 840875

Miami, Florida, 33126, United States
Chiesi Clinical Trial Site 840876

Dallas, Texas, 75225, United States
Chiesi Clinical Trial Site 840877

San Diego, California, 92123, United States
Chiesi Clinical Trial Site 840878

Tulsa, Oklahoma, 74133, United States
Chiesi Clinical Trial Site 840879

Pomona, California, 91768, United States
Chiesi Clinical Trial Site 840880

St. Petersburg, Florida, 33713, United States
Chiesi Clinical Trial Site 840881

Westminster, California, 92683, United States
Chiesi Clinical Trial Site 840882

Bellingham, Washington, 98225, United States
Chiesi Clinical Trial Site 840883

Los Angeles, California, 90025, United States
Chiesi Clinical Trial Site 840884

Grants Pass, Oregon, 97527, United States
Chiesi Clinical Trial Site 840885

Warwick, Rhode Island, 02886, United States
Chiesi Clinical Trial Site 840887

Miami, Florida, 33134, United States
Chiesi Clinical Trial Site 840888

Saint Charles, Missouri, 63301, United States
Chiesi Clinical Trial Site 840889

St. Petersburg, Florida, 33707, United States
Chiesi Clinical Trial Site 840890

North Hollywood, California, 91606, United States
Chiesi Clinical Trial Site 840891

Spartanburg, South Carolina, 29303, United States
Chiesi Clinical Trial Site 840892

Anderson, South Carolina, 29621, United States
Chiesi Clinical Trial Site 840893

Murray, Utah, 84107, United States
Chiesi Clinical Trial Site 840894

Rock Hill, South Carolina, 29732, United States
Chiesi Clinical Trial Site 840895

Chandler, Arizona, 85224, United States
Chiesi Clinical Trial Site 840896

Long Beach, California, 90805, United States
Chiesi Clinical Trial Site 840897

Henderson, Nevada, 89052, United States
Chiesi Clinical Trial Site 840899

Monroe, North Carolina, 28112, United States

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