Triple-drug inhaler aims to tame severe asthma in teens and adults

NCT ID NCT04609904

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests whether a three-in-one inhaler (budesonide, glycopyrronium, and formoterol) works better than two-drug inhalers for people aged 12 to 80 with asthma that is not well controlled by their current treatment. Participants receive either the triple inhaler, a two-drug version, or an existing two-drug inhaler (Symbicort) for up to 24 weeks. The main goals are to measure improvements in lung function and reductions in severe asthma attacks.

What this could mean

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

Active substance: Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
What this could lead to: If successful, this triple-combination inhaler could offer better asthma control and fewer severe attacks for people whose asthma is not well managed with standard two-drug inhalers.
What could go wrong: This is a large Phase 3 trial, but results may not apply to all asthma patients. The added benefit over existing treatments may be modest, and side effects from the extra drug are possible.

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

2,187 people

The number who actually took part.

Started

Mar 2021

Finished

Mar 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. Documented history of physician-diagnosed asthma \> and/or = 1 year prior to V1. 3. Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1. 4. ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization). 5. FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization) * Participants \> and/or = 18 years of age: \< 80% * Participants 12 to \<18 years of age: \< 90% 6. FEV1 post-albuterol at V2 or V3 (if repeat needed). • Participants \> and/or = 18 years of age: Increase \> and/or = 12% and \> and/or = 200 mL. * Participants 12 to \<18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3. * Note: Even if there is documented history of reversibility, all participants must be assessed for reversibility at Visit 2 (and Visit 3, if reversibility is not demonstrated at Visit 2) to provide reversibility baseline data for characterization. 7. Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol. 8. Demonstrate acceptable MDI/pMDI administration technique. 9. Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation). 10. eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization). 11. No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization. Exclusion Criteria: 1\. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1. 2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate. 2b. Any marketed or investigational biologics within 3 months or 5 halflives of V1, whichever is longer and must not be used during study duration. 3\. Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana). 4\. Current evidence of COPD. 5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1. 5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study. 5c. Depot corticosteroid use for any reason within 3 months of V1. 6\. Use of LAMA, either alone or as part of an inhaled combination therapy, in the 12 weeks prior to Visit 1. 7\. Use of oral beta2-agonist within 3 months of V1. 8\. Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration. 9\. Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1. 10\. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s). 11\. Hospitalization for asthma within 2 months of Visit 1. 12\. Known history of drug or alcohol abuse within 12 months of Visit 1. 13\. Regular use of a nebulizer or a home nebulizer for receiving asthma medications. 14\. Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration. 15\. 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 the protocol is prohibited for use during study duration. 16\. Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI. 17\. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members. 18\. For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator. Please refer to the study protocol for the complete inclusion and exclusion criteria list

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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

Research Site

Chandler, Arizona, 85224, United States
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Tempe, Arizona, 85283, United States
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Tucson, Arizona, 85741, United States
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Hot Springs, Arkansas, 71913, United States
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Bakersfield, California, 93301, United States
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Carlsbad, California, 92008, United States
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Huntington Beach, California, 92647, United States
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Lancaster, California, 93534, United States
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Long Beach, California, 90815, United States
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Mission Viejo, California, 92691, United States
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North Hollywood, California, 91606, United States
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Northridge, California, 91324, United States
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Rancho Cucamonga, California, 91730, United States
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Sacramento, California, 95823, United States
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San Diego, California, 92123, United States
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San Jose, California, 95117, United States
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Ventura, California, 93003, United States
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Walnut Creek, California, 94598, United States
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Colorado Springs, Colorado, 80907, United States
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Colorado Springs, Colorado, 80910, United States
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Wheat Ridge, Colorado, 80033, United States
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Newark, Delaware, 19713, United States
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Boca Raton, Florida, 33487, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, 33765, United States
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Cutler Bay, Florida, 33189, United States
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DeBary, Florida, 32713, United States
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Hialeah, Florida, 33016, United States
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Lakeland, Florida, 33813, United States
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Miami, Florida, 33135, United States
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Tampa, Florida, 33615, United States
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Acworth, Georgia, 30101, United States
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Atlanta, Georgia, 30322, United States
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Atlanta, Georgia, 30350, United States
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Snellville, Georgia, 30078, United States
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Boise, Idaho, 83706, United States
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Chicago, Illinois, 60621, United States
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Normal, Illinois, 61761, United States
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Peoria, Illinois, 61636, United States
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Evansville, Indiana, 47715, United States
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Marrero, Louisiana, 70072, United States
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Zachary, Louisiana, 70791, United States
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Baltimore, Maryland, 21224, United States
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White Marsh, Maryland, 21162, United States
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Fall River, Massachusetts, 02723, United States
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Farmington Hills, Michigan, 48336, United States
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Rochester, Michigan, 48307, United States
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Troy, Michigan, 48085, United States
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St Louis, Missouri, 63141, United States
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Warrensburg, Missouri, 64093, United States
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North Las Vegas, Nevada, 89030, United States
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Portsmouth, New Hampshire, 03801, United States
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Ocean City, New Jersey, 07712, United States
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Albuquerque, New Mexico, 87102, United States
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Brooklyn, New York, 11236, United States
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The Bronx, New York, 10459, United States
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The Bronx, New York, 10461, United States
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The Bronx, New York, 10468, United States
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Greensboro, North Carolina, 27405, United States
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Huntersville, North Carolina, 28078, United States
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Monroe, North Carolina, 28112, United States
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Columbus, Ohio, 43215, United States
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Portland, Oregon, 97202, United States
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Jenkintown, Pennsylvania, 19046, United States
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Philadelphia, Pennsylvania, 19107, United States
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Spartanburg, South Carolina, 29303, United States
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Knoxville, Tennessee, 37909, United States
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Amarillo, Texas, 79106, United States
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Cedar Park, Texas, 78613, United States
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Dallas, Texas, 75254, United States
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Denison, Texas, 75020, United States
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Forney, Texas, 75126, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77099, United States
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Lewisville, Texas, 75067, United States
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McKinney, Texas, 75069, United States
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North Richland Hills, Texas, 76180, United States
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Pearland, Texas, 77584, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78258, United States
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Sugar Land, Texas, 77478, United States
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Victoria, Texas, 77901, United States
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Roy, Utah, 84067, United States
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Abingdon, Virginia, 24210, United States
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Burke, Virginia, 22015, United States
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Williamsburg, Virginia, 23188, United States
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Milwaukee, Wisconsin, 53226, United States
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Milwaukee, Wisconsin, 53228, United States
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Botucatu, 18618-970, Brazil
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Porto Alegre, 9002-060, Brazil
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Porto Alegre, 90430-001, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Santo André, 09080-110, Brazil
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São Paulo, 05403-000, Brazil
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Sorocaba, 18040-425, Brazil
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Baotou, 014010, China
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Beijing, 100020, China
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Changsha, 410005, China
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Changsha, 410008, China
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Changsha, 430033, China
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Changzhi, 46000, China
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Chengdu, 610072, China
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Chengdu, 611130, China
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Chizhou, 247099, China
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Chongqing, 400010, China
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Chongqing, 400038, China
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Dongguan, 523413, China
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Dongyang, 322100, China
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Fuzhou, 350025, China
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Guangzhou, 510062, China
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Guangzhou, 510100, China
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Guangzhou, 510120, China
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Guangzhou, 510180, China
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Guangzhou, 510280, China
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Guangzhou, 510630, China
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Haikou, 570208, China
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Haikou, 570311, China
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Hangzhou, 310005, China
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Hangzhou, 310009, China
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Hefei, 230000, China
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Hefei, 230011, China
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Hefei, 230061, China
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Huai'an, 223300, China
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Huizhou, 516001, China
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Jinan, 250014, China
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Jinhua, 321000, China
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Kunming, 650032, China
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Kunming, 650051, China
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Lanzhou, 730000, China
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Liuzhou, 545006, China
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Luoyang, 471003, China
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Nanchang, 330006, China
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Nanchong, 637000, China
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Nanjing, 210006, China
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Nanjing, 210008, China
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Nanjing, 210009, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Qingdao, 266000, China
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Qingdao, 266042, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Shanghai, 200065, China
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Shanghai, 200080, China
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Shanghai, 200092, China
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Shanghai, 200240, China
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Shanghai, 201199, China
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Shaoxing, 312000, China
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Shengyang, 110004, China
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Shenyang, 110001, China
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Shenyang, 110015, China
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Shenyang, 110075, China
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Shenzhen, 518020, China
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Shenzhen, 518036, China
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Shenzhen, 518039, China
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Shijiazhuang, 50051, China
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Taiyuan, 030001, China
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Taiyuan, 030032, China
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Taizhou, 318020, China
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Ürümqi, 830054, China
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Weifang, 261000, China
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Wuhan, 430010, China
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Wuhan, 430030, China
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Wuhu, 241000, China
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Xi'an, 710004, China
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Xi'an, 710077, China
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Xinxiang, 453002, China
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Xuzhou, 221000, China
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Xuzhou, 221009, China
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Yangzhou, 225001, China
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Yantai, 264000, China
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Yinchuan, 750001, China
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Yinchuan, 750004, China
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Yueyang, 414000, China
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Zhangzhou, 363099, China
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Zhanjiang, 524001, China
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Zhengzhou, 450000, China
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Zhuji, 311899, China
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Barranquilla, 080020, Colombia
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Bogotá, 110221, Colombia
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Cartagena, 130013, Colombia
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Medellín, 050621, Colombia
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Rionegro, 054047, Colombia
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Brandýs nad Labem, 250 01, Czechia
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Jindřichův Hradec, 377 01, Czechia
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Lovosice, 410 02, Czechia
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Mladá Boleslav, 293 01, Czechia
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Nový Bor, 473 01, Czechia
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Prague, 148 00, Czechia
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Prague, 190 00, Czechia
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Rokycany, 337 22, Czechia
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Strakonice, 38601, Czechia
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Teplice, 415 01, Czechia
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Varnsdorf, 407 47, Czechia
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Bamberg, 96049, Germany
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Berlin, 10119, Germany
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Berlin, 10367, Germany
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Berlin, 10717, Germany
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Berlin, 10787, Germany
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Berlin, 12159, Germany
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Berlin, 12203, Germany
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Berlin, 13187, Germany
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Darmstadt, 64283, Germany
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Frankfurt, 60596, Germany
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Frankfurt am Main, 60389, Germany
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Frankfurt am Main, 60596, Germany
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Fürstenwalde, 15517, Germany
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Geesthacht, 21502, Germany
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Hanover, 30449, Germany
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Hanover, D-30173, Germany
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Heidelberg, 69115, Germany
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Koblenz, 56068, Germany
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Landsberg, 86899, Germany
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Leipzig, 04103, Germany
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Leipzig, 04207, Germany
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Leipzig, 04299, Germany
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Mainz, 55128, Germany
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München-Pasing, 81241, Germany
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Witten, 58452, Germany
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Alexandroupoli, 68100, Greece
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Athens, 11521, Greece
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Athens, 11527, Greece
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Athens, 12462, Greece
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Athens, 17562, Greece
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Corfu, 49100, Greece
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Exohi Thessaloniki, 57010, Greece
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Ioannina, 45500, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 56429, Greece
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Thessaloniki, 57010, Greece
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Ashkelon, 7830604, Israel
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Beersheba, 84101, Israel
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Haifa, 31096, Israel
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Haifa, 34362, Israel
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Holon, 5837738, Israel
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Jerusalem, 9103102, Israel
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Jerusalem, 9112001, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 4920235, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 6423906, Israel
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Cuernavaca, 62290, Mexico
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Durango, 43080, Mexico
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Guadalajara, 44200, Mexico
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Mazatlán, 82000, Mexico
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Mérida, 97070, Mexico
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Monterrey, 64620, Mexico
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Monterrey, 64710, Mexico
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Monterrey, 64718, Mexico
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Veracruz, 91910, Mexico
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Villahermosa, 86035, Mexico
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Zapopan, 45138, Mexico
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Amadora, 2720-276, Portugal
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Braga, 4710, Portugal
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Coimbra, 3040-316, Portugal
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Figueira da Foz Municipality, 3094-001, Portugal
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Guimarães, 4835-044, Portugal
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Lisbon, 1649-035, Portugal
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Lisbon, 1998-018, Portugal
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Matosinhos Municipality, 4454-509, Portugal
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Ponce, 00717, Puerto Rico
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Ponce, 00780, Puerto Rico
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Chelyabinsk, 454106, Russia
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Izhevsk, 426035, Russia
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Kazan', 420008, Russia
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Kemerovo, 650002, Russia
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Moscow, 115522, Russia
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Moscow, 125284, Russia
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Omsk, 644050, Russia
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Penza, 440067, Russia
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Perm, 614000, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 195257, Russia
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Saratov, 410028, Russia
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Saratov, 410053, Russia
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Tomsk, 634050, Russia
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Ulyanovsk, 432009, Russia
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Bojnice, 972 01, Slovakia
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Kežmarok, 060 01, Slovakia
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Košice, 04022, Slovakia
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Levice, 934 01, Slovakia
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Levice, 93401, Slovakia
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Nové Zámky, 94001, Slovakia
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Poprad, 058 01, Slovakia
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Prešov, 081 81, Slovakia
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Ružomberok, 034 26, Slovakia
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Šurany, 94201, Slovakia
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Topoľčany, 95501, Slovakia
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Žilina, 010 01, Slovakia
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Bloemfontein, 9301, South Africa
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Cape Town, 7700, South Africa
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Cape Town, 7764, South Africa
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Durban, 4001, South Africa
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Durban, 4091, South Africa
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Durban, 4093, South Africa
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Durban, 4450, South Africa
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eMkhomazi, 4170, South Africa
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Johannesburg, 2001, South Africa
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Lenasia, 1821, South Africa
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Lenasia Ext8, 1820, South Africa
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Panorama, 7500, South Africa
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Pretoria, 0186, South Africa
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Tygervalley, 7530, South Africa
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Adana, 1260, Turkey (Türkiye)
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Ankara, 06, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34844, Turkey (Türkiye)
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Izmir, 35110, Turkey (Türkiye)
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Mersin, 33343, Turkey (Türkiye)
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Pamukkale, 20070, Turkey (Türkiye)
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Blackpool, FY3 7EN, United Kingdom
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Bradford, BD9 6RJ, United Kingdom
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Corby, NN17 2UR, United Kingdom
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Hull, HU16 5JQ, United Kingdom
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Leicester, LE5 4LJ, United Kingdom
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Rhyl, LL18 1DA, United Kingdom

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