Could a Two-Drug rescue inhaler cut asthma attacks?
NCT ID NCT06422689
First seen Jun 24, 2026 · Last updated Jul 17, 2026 · Updated 4 times
Summary
This study tests whether switching from a standard rescue inhaler (albuterol alone) to one that also contains an anti-inflammatory steroid (budesonide) can reduce severe asthma attacks. About 1,500 adults with asthma who have had at least one severe attack in the past year will use the combination inhaler as needed. Researchers will compare how often attacks occur before and after the switch.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Albuterol and budesonide inhalation aerosol
- What this could lead to
- If it works, this could offer a better rescue inhaler for asthma that reduces severe attacks and the need for oral steroids.
- What could go wrong
- This is an early-phase, single-arm study without a placebo group, so results may not prove the combination is better than standard care. Side effects from budesonide 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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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1,511 people
The number who actually took part.
- Started
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May 2024
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 130 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Adults aged 18 years and above as of enrollment date. 2. At least 1 diagnosis of asthma prior to the enrollment date documented in patient record. 3. At least 1 prescription filled for Short-acting beta-agonist (SABA)-only inhaler (i.e., albuterol-only or levalbuterol only inhalers) within 12 months before enrollment date. 4. At least 1 severe asthma exacerbation within 12 months before enrollment date. 5. Had both medical and pharmacy insurance coverage (e.g., Medicare, Medicaid, and commercial insurance) for at least 12 months before enrollment date and without foreseeable plans to discontinue insurance coverage within 12 months after enrollment date. 6. Participants also need to meet each of the following inclusion criteria: 1. Willingness to use albuterol and budesonide as rescue as instructed by their physician, prescribing information, and United States instruction for use (USIFU). 2. Willingness to respond to quarterly safety inquiries. 3. Willingness to participate in quarterly electronic patient-reported outcome (PRO) surveys via email or text. 4. Physician decision that participant is eligible for treatment with albuterol and budesonide as rescue according to the approved United States prescribing information (USPI). Exclusion Criteria: 1. Conditions with major respiratory diagnoses including chronic obstructive pulmonary disease (COPD), cystic fibrosis, pulmonary fibrosis, bronchiectasis, respiratory tract cancer, bronchopulmonary dysplasia, sarcoidosis, lung cancer, interstitial lung disease, pulmonary hypertension, and tuberculosis in 12 months before the enrollment date. 2. Inpatient admission or emergency department or urgent care visit due to asthma in the 10 days before enrollment date, or self-reported use of systemic corticosteroid for the treatment of asthma in the 10 days before enrollment date. Participants who were screen-failed due to this criterion may be re-screened once the participant is more than 10 days post asthma-related inpatient admission, emergency department or urgent care visit, or systemic corticosteroid use. 3. Chronic use of oral corticosteroids (for any condition) within 3 months before enrollment date. Chronic use of oral corticosteroids is defined as: daily or every other day use for 21 days or longer. 4. History of albuterol and budesonide as rescue use within 12 months before enrollment date. 5. History of any malignancy (except non-melanoma neoplasms of skin) in 12 months before the enrollment date. 6. For females only - currently pregnant or breastfeeding on enrollment date. Participants are excluded from the study if any of the following criteria apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
North Hollywood, California, 91602, United States
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Research Site
Walnut Creek, California, 94598, United States
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Research Site
Louisville, Kentucky, 40217, United States
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Research Site
Boston, Massachusetts, 02111, United States
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Research Site
Ann Arbor, Michigan, 48109, United States
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Research Site
Flint, Michigan, 48532, United States
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Research Site
Minneapolis, Minnesota, 55425, United States
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Research Site
Asheville, North Carolina, 28803, United States
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Research Site
Greenville, North Carolina, 27834, United States
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Research Site
DuBois, Pennsylvania, 15801, United States
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Research Site
Austin, Texas, 78738, United States
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