Greener asthma inhaler on the horizon? phase 3 trial underway

NCT ID NCT06502366

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This study tests whether a new propellant (HFO) for the budesonide/albuterol inhaler works as well as the current one (HFA) in adults with asthma. Over 400 participants will use three different inhalers over 12 weeks to compare lung function. The goal is to see if the new propellant is equally effective, potentially leading to a more environmentally friendly option.

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 albuterol (combination inhaler)
What this could lead to: If successful, this could confirm that a more environmentally friendly propellant works just as well as the current one for asthma control.
What could go wrong: This is a late-stage trial, but it only tests equivalence, not a new treatment. The new propellant might not perform identically, or results may not apply to all asthma patients.

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

424 people

The number who actually took part.

Started

Jul 2024

Finished

Apr 2026

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 years and older

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: * Participant must be ≥ 18 years of age at the time of signing the ICF. * Participants who have physician diagnosed asthma as defined by GINA for at least 12 months prior to Visit 1. * Eligible participants are on either a) no daily inhaled maintenance therapy or b) daily inhaled maintenance therapy with low-dose ICS or low-dose ICS-LABA. Participants who are on low-dose ICS maintenance therapy are required to be stable on therapy for a minimum of 3 months prior to Visit 1; participants using low-dose ICSLABA maintenance regimens are required to be stable on therapy for a minimum of 6 months prior to Visit 1. * Participants with a pre-bronchodilator FEV1 of ≥ 60% and \< 90% predicted normal at Visit 1 or Visit 1a. * Participants with a pre-dose FEV1 of ≥ 60% and \< 90% predicted normal at Visit 2 that is within ± 20% of their Visit 1 pre-bronchodilator FEV1. * Participants who demonstrate bronchodilator responsiveness defined as a \> 12% and \> 200 mL increase in FEV1 relative to baseline following administration of study provided SABA at Visit 1 or Visit 1a. * Participants able to demonstrate acceptable spirometry performance as defined by the acceptability and repeatability criteria in the ATS/ERS Standardization of Spirometry 2019 update * Participants who are willing and, in the opinion of the investigator, able to adjust current asthma therapy, as required by the protocol. * Participants with a body mass index \< 40 kg/m2. * Females must not be of childbearing potential or, if of childbearing potential, using a form of birth control Exclusion Criteria: * Confirmed or suspected diagnosis of COPD or clinically significant non-asthma airway/lung disease. * Systemic corticosteroid use (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for any respiratory, immune, or allergy-attributed disease within 6 months prior to Visit 1. * An upper respiratory infection requiring antibiotic treatment that is not resolved within 7 days prior to Visit 1. * A lower respiratory infection in the 4 weeks prior to Visit 1. * Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, positive pressure ventilation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1. * Hospitalization due to asthma within 12 months or systemic corticosteroid usage (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for asthma within 6 months prior to Visit 1. * A severe asthma exacerbation during the run-in period * An ePRO device alert during the run-in period with investigator-confirmed worsening asthma symptoms * Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia, coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), or gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease) disorders. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or that could affect the efficacy or safety analyses if the disease/condition exacerbated during the study. * Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1 * Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1. * Known history of drug or alcohol abuse within 12 months of Visit 1 or known abuse at any time during the study.

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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

Mobile, Alabama, 36608, United States
Research Site

Sheffield, Alabama, 35660, United States
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Phoenix, Arizona, 85018, United States
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Little Rock, Arkansas, 72205, United States
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Encinitas, California, 92024, United States
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Fullerton, California, 92835, United States
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Gardena, California, 90247, United States
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Huntington Beach, California, 92647, United States
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La Mesa, California, 91942, United States
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Los Angeles, California, 90025, United States
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Los Angeles, California, 90048, United States
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Sacramento, California, 95821, United States
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San Bernardino, California, 92408, 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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Santa Ana, California, 92704, United States
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Stockton, California, 95207, United States
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Westminster, California, 92683, United States
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Englewood, Colorado, 80110, United States
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Wheat Ridge, Colorado, 80033, United States
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Washington D.C., District of Columbia, 20016, United States
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Boynton Beach, Florida, 33435, United States
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Miami, Florida, 33175, United States
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Tallahassee, Florida, 32308, United States
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Tampa, Florida, 33607, United States
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Atlanta, Georgia, 30328, United States
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Rincon, Georgia, 31326, United States
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Savannah, Georgia, 31406, United States
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Meridian, Idaho, 83646, United States
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River Forest, Illinois, 60305, United States
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Evansville, Indiana, 47715, United States
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Valparaiso, Indiana, 46383, United States
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Sioux City, Iowa, 51106, United States
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Louisville, Kentucky, 40217, United States
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Lafayette, Louisiana, 70508, United States
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New Orleans, Louisiana, 70119, United States
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White Marsh, Maryland, 21162, United States
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Flint, Michigan, 48504, United States
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Columbia, Missouri, 65203, United States
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St Louis, Missouri, 63141, United States
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Omaha, Nebraska, 68134, United States
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Monticello, New York, 12701, United States
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New York, New York, 10036, United States
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Watertown, New York, 13601, United States
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Charlotte, North Carolina, 28273, United States
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Raleigh, North Carolina, 27607, United States
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Cincinnati, Ohio, 45236, United States
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Oklahoma City, Oklahoma, 73120, United States
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Tulsa, Oklahoma, 74136, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97202, United States
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Pottstown, Pennsylvania, 19464, United States
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Scottdale, Pennsylvania, 15683, United States
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Greenville, South Carolina, 29615, United States
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North Charleston, South Carolina, 29420, United States
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Boerne, Texas, 78006, United States
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Dallas, Texas, 75231, United States
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DeSoto, Texas, 75115, United States
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El Paso, Texas, 79924, United States
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Kingwood, Texas, 77339, United States
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McKinney, Texas, 75069, United States
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Pearland, Texas, 77584, United States
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San Antonio, Texas, 78258, United States
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Victoria, Texas, 77901, United States
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West Jordan, Utah, 84088, United States
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Burke, Virginia, 22015, United States
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Portsmouth, Virginia, 23703, United States
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Spokane, Washington, 99218, United States
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Morgantown, West Virginia, 26505, United States
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Milwaukee, Wisconsin, 53228, United States
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Baotou, 014010, China
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Changsha, 410015, China
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Chengdu, 610072, China
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Chizhou, 247099, China
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Chongqing, 401320, China
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Guangzhou, 510150, China
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Guangzhou, 510163, China
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Haikou, 570208, China
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Hangzhou, 310005, China
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Hefei, 230061, China
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Hohhot, 010017, China
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Huizhou, 516001, China
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Jinan, 250001, China
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Jinhua, China
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Lanzhou, 730000, China
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Linhai, 317000, China
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Nanchang, 330006, China
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Pingxiang, 337055, China
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Qingdao, 266011, China
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Shanghai, 200080, China
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Shanghai, 201199, China
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Shanghai, 310000, China
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Shenyang, 110004, China
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Shenzhen, 518020, 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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Wenzhou, 325027, China
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Wuhan, 430030, China
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Xuzhou, 221000, China
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Xuzhou, 221009, China
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Yangzhou, 225003, China
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Yinchuan, 750001, China
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Zhengzhou, 450003, China
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Zhuji, 311899, China
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Cheras, 56000, Malaysia
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Petaling Jaya, 47500, Malaysia
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Chihuahua City, 31200, Mexico
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Cuernavaca, 62290, Mexico
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Culiacán, 80100, Mexico
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Durango, 34000, Mexico
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Guadalajara, 44130, Mexico
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Guadalajara, 44200, Mexico
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Mazatlán, 82000, Mexico
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Monterrey, 64060, Mexico
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Monterrey, 64465, Mexico
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San Juan del Río, 76800, Mexico
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Tijuana, 22010, Mexico
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Veracruz, 91900, Mexico
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Zapopan, 45138, Mexico
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Bangkoknoi, 10700, Thailand
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Khon Kaen, 40002, Thailand
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Mueang, 50200, Thailand
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Ratchathewi, 10400, Thailand
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Can Tho, 900000, Vietnam
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Haiphong, 180000, Vietnam
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam

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