New asthma inhaler combo shows promise in large trial

NCT ID NCT05202262

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new inhaler containing two medicines (budesonide and formoterol) in 645 people aged 12 to 80 with asthma that was not well controlled. The trial compared the new inhaler to a standard budesonide-only inhaler and an existing combination inhaler over 24 weeks. The goal was to see if the new inhaler improves lung function and is safe for daily use.

What this could mean

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

Active substance: Budesonide and formoterol fumarate (combination inhaler)
What this could lead to: If successful, this could offer a new, effective option for people whose asthma is not well controlled with current treatments.
What could go wrong: This is a completed Phase 3 trial, but results may not apply to all asthma patients. The study is relatively short (24 weeks), so long-term safety and effectiveness are not fully known.

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

645 people

The number who actually took part.

Started

Jan 2022

Finished

Feb 2025

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

12 to 80 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: 1. 12 to 80 years of age, male and female, BMI \<40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control. 2. Participants who have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1, according to GINA guidelines \[GINA 2020\]. Healthcare records for one year prior to Visit 1 must be provided for adolescent participants (12 to \< 18 years of age) to ensure consistent evaluation and follow-up of treatment in those participants. 3. Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with the ICS doses, for at least 8 weeks prior to Visit 1. 4. ACQ-7 total score ≥ 1.5 at Visits 1 and 4. 5. Pre-bronchodilator/pre-dose FEV1 \<90% predicted normal value at Visits 1, 2 and 3, and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization). 6. Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of ≥ 12% and ≥ 200 mL for participants ≥ 18 years of age OR a post-albuterol increase in FEV1 of ≥ 12% for participants 12 to \< 18 years of age, either in the 12 months prior to Visit 1 or at Visit 2 or Visit 3. 7. A pre-bronchodilator/pre-dose FEV1 at Visits 2, 3, and 4 that have not changed 20% or more (increase or decrease) from the pre-bronchodilator/pre-dose FEV1 recorded at the previous visit. 8. Asthma stability during run-in based on Investigator discretion using the symptom worsening assessment. 9. Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol. 10. Demonstrate acceptable MDI administration technique. 11. eDiary compliance ≥ 70% during screening, defined as completing the daily eDiary and answering "Yes" to taking 2 puffs of run-in BD MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization. Exclusion Criteria: 1. Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s). 2. Any respiratory infection or asthma exacerbation treated with systemic corticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 and throughout the Screening Period. 3. Hospitalization for asthma within 8 weeks of Visit 1. 4. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary (eg, active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD). Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis. 5. Known history of drug or alcohol abuse within 12 months of Visit 1. 6. Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1. 7. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in this protocol is prohibited for use during study duration. 8. Previous or current randomization into studies within the AEROSPHERE program including KALOS, LOGOS, VATHOS, LITHOS, or any glycopyrronium studies (PT001). 9. Use of a nebulizer or a home nebulizer for receiving asthma medications. 10. Do not meet the stable dosing period prior to Visit 1 or unable to abstain from protocol-defined prohibited medications during Screening and Treatment Periods. 11. Receipt of COVID-19 vaccine (regardless of vaccine delivery platform, eg, vector, lipid nanoparticle) \< 7 days prior to Visit 1 (from last vaccination or booster dose). 12. Participants with known hypersensitivity to beta2-agonists, corticosteroids, or any component of the MDI. 13. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or ECG, which in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study. 14. Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana). 15. Planned hospitalization during the study. 16. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members. 18. Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements. 19. For women only - currently pregnant (confirmed with positive highly sensitive urine pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

Research Site

Chandler, Arizona, 85224, United States
Research Site

Tucson, Arizona, 85745, United States
Research Site

Bakersfield, California, 93301, United States
Research Site

Fresno, California, 93720, United States
Research Site

Huntington Beach, California, 92647, United States
Research Site

La Palma, California, 90623, United States
Research Site

Lincoln, California, 95648, United States
Research Site

Los Angeles, California, 90017, United States
Research Site

Los Angeles, California, 90025, United States
Research Site

Los Angeles, California, 90048, United States
Research Site

Newport Beach, California, 92663, United States
Research Site

Northridge, California, 91324, United States
Research Site

Sacramento, California, 95823, United States
Research Site

San Diego, California, 92120, United States
Research Site

San Diego, California, 92123, United States
Research Site

San Jose, California, 95117, United States
Research Site

Denver, Colorado, 80230, United States
Research Site

Wheat Ridge, Colorado, 80033, United States
Research Site

Cutler Bay, Florida, 33189, United States
Research Site

DeLand, Florida, 32720, United States
Research Site

Miami, Florida, 33155, United States
Research Site

Miami, Florida, 33173, United States
Research Site

Miami, Florida, 33175, United States
Research Site

Miami, Florida, 33180, United States
Research Site

Tampa, Florida, 33607, United States
Research Site

Atlanta, Georgia, 30361, United States
Research Site

Peoria, Illinois, 61636, United States
Research Site

Lexington, Kentucky, 40509, United States
Research Site

White Marsh, Maryland, 21162, United States
Research Site

North Dartmouth, Massachusetts, 02747, United States
Research Site

Farmington Hills, Michigan, 48336, United States
Research Site

Columbia, Missouri, 65203, United States
Research Site

Saint Charles, Missouri, 63301, United States
Research Site

St Louis, Missouri, 63141, United States
Research Site

Kalispell, Montana, 59901, United States
Research Site

Missoula, Montana, 59808, United States
Research Site

Bellevue, Nebraska, 68123, United States
Research Site

Omaha, Nebraska, 68114, United States
Research Site

Henderson, Nevada, 89052, United States
Research Site

North Las Vegas, Nevada, 89030, United States
Research Site

Portsmouth, New Hampshire, 03801, United States
Research Site

Skillman, New Jersey, 08558, United States
Research Site

Gastonia, North Carolina, 28054, United States
Research Site

Monroe, North Carolina, 28112, United States
Research Site

Raleigh, North Carolina, 27607, United States
Research Site

Cincinnati, Ohio, 45236, United States
Research Site

Columbus, Ohio, 43215, United States
Research Site

Edmond, Oklahoma, 73034, United States
Research Site

Oklahoma City, Oklahoma, 73120, United States
Research Site

Portland, Oregon, 97202, United States
Research Site

Pittsburgh, Pennsylvania, 15236, United States
Research Site

Knoxville, Tennessee, 37909, United States
Research Site

Austin, Texas, 78759, United States
Research Site

Beaumont, Texas, 77701, United States
Research Site

Boerne, Texas, 78006, United States
Research Site

Dallas, Texas, 75231, United States
Research Site

El Paso, Texas, 79912, United States
Research Site

Forney, Texas, 75126, United States
Research Site

Houston, Texas, 77093, United States
Research Site

Red Oak, Texas, 75154, United States
Research Site

San Antonio, Texas, 78229, United States
Research Site

San Antonio, Texas, 78258, United States
Research Site

Victoria, Texas, 77901, United States
Research Site

Waco, Texas, 76712, United States
Research Site

Williamsburg, Virginia, 23188, United States
Research Site

Milwaukee, Wisconsin, 53228, United States
Research Site

Calgary, Alberta, T3B 0M3, Canada
Research Site

Calgary, Alberta, T3E 7M8, Canada
Research Site

Edmonton, Alberta, T5A 4L8, Canada
Research Site

Kamloops, British Columbia, V2C 5T1, Canada
Research Site

Winnipeg, Manitoba, R3L 1Z5, Canada
Research Site

Moncton, New Brunswick, E1G 1A7, Canada
Research Site

Ajax, Ontario, L1S 2J5, Canada
Research Site

Burlington, Ontario, L7N 3V2, Canada
Research Site

Stouffville, Ontario, L4A 1H2, Canada
Research Site

Toronto, Ontario, M9V 4B4, Canada
Research Site

Windsor, Ontario, N8X 2G1, Canada
Research Site

Windsor, Ontario, N8X-5A6, Canada
Research Site

Montreal, Quebec, H2V 2K1, Canada
Research Site

Québec, Quebec, G1G 3Y8, Canada
Research Site

Québec, Quebec, G1V 4W2, Canada
Research Site

Québec, Quebec, G2J 0C4, Canada
Research Site

Berlin, 10119, Germany
Research Site

Berlin, 10787, Germany
Research Site

Berlin, 10961, Germany
Research Site

Berlin, 12157, Germany
Research Site

Berlin, 13156, Germany
Research Site

Frankfurt am Main, 60596, Germany
Research Site

Landsberg, 86899, Germany
Research Site

Leipzig, 04157, Germany
Research Site

Leipzig, 04207, Germany
Research Site

Leipzig, 04299, Germany
Research Site

Magdeburg, 39120, Germany
Research Site

München-Pasing, 81241, Germany
Research Site

Schleswig, 24837, Germany
Research Site

Wiesbaden, 65189, Germany
Research Site

Witten, 58452, Germany
Research Site

Brescia, 25123, Italy
Research Site

Mantua, 46100, Italy
Research Site

Naples, 80131, Italy
Research Site

Roma, 00133, Italy
Research Site

Roma, 00168, Italy
Research Site

Rome, 00165, Italy
Research Site

Tradate, 21049, Italy
Research Site

Chūōku, 103-0022, Japan
Research Site

Chūōku, 103-0027, Japan
Research Site

Chūōku, 103-0028, Japan
Research Site

Chūōku, 104-0031, Japan
Research Site

Fukui-shi, 910-8526, Japan
Research Site

Fukuoka, 819-8555, Japan
Research Site

Himeji-shi, 672-8064, Japan
Research Site

Kagoshima, 890-0053, Japan
Research Site

Kishiwada-shi, 596-8501, Japan
Research Site

Kodaira-shi, 187-0024, Japan
Research Site

Kokubunji-shi, 185-0014, Japan
Research Site

Kusatsu-shi, 525-8585, Japan
Research Site

Kyoto, 601-8213, Japan
Research Site

Kyoto, 612-8555, Japan
Research Site

Mizunami-shi, 509-6134, Japan
Research Site

Obihiro-shi, 080-0013, Japan
Research Site

Osaka, 531-0073, Japan
Research Site

Sapporo, 062-0931, Japan
Research Site

Setagaya-ku, 158-0097, Japan
Research Site

Shibuya-ku, 150-0013, Japan
Research Site

Toon-shi, 791-0281, Japan
Research Site

Toshima-ku, 170-0002, Japan
Research Site

Toshima-ku, 170-0003, Japan
Research Site

Toshima-ku, 171-0014, Japan
Research Site

Utsunomiya, 329-1193, Japan
Research Site

Yokohama, 223-0059, Japan
Research Site

Yokohama, 232-0024, Japan
Research Site

Yokohama, 232-0064, Japan
Research Site

Badalona, 08916, Spain
Research Site

Barcelona, 08017, Spain
Research Site

Bilbao, 48002, Spain
Research Site

Granada, 18004, Spain
Research Site

Granada, 18014, Spain
Research Site

Madrid, 28041, Spain
Research Site

Santiago de Compostela, 15702, Spain
Research Site

Vigo, 36201, Spain
Research Site

Hanoi, 100000, Vietnam
Research Site

Ho Chi Minh City, 700000, Vietnam

More trials for these conditions

Other studies related to the condition(s) this trial covers.