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Asthma showdown: which inhaler strategy wins?
NCT ID NCT06596512
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests two ways to use asthma inhalers to prevent serious attacks. One strategy (MART) uses a combination inhaler for daily control and quick relief. The other (PARTICS) adds a separate steroid inhaler whenever a rescue inhaler is used. About 4,100 adults with moderate-to-severe asthma will be followed for 16 months to see which approach reduces flare-ups better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Inhaled corticosteroids (ICS) and ICS/long-acting beta-agonist (LABA) combination inhalers
- What this could lead to
- If successful, this trial could show that the simpler PARTICS strategy is as good as or better than MART, giving patients more options to prevent asthma attacks.
- What could go wrong
- This is a large trial but compares two already-known treatments, so no breakthrough is expected. Results may not apply to all asthma patients, and individual responses can vary.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 4,100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 75 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: * Clinician diagnosis of asthma for ≥1 year; * Age at enrollment--18-75 years old inclusive; * One or more AEXs that occurred \< 12 months prior to enrollment. An AEX is defined as an asthma deterioration that either requires 72 hours or more of an oral or parenteral steroids OR a hospital stay for more than 24 hours for asthma. In the case of patients on biologics for asthma, the exacerbation must have also occurred after at least 6 months of biologic therapy; * Currently prescribed an ICS/LABA containing preparation containing at least the lowest dose of ICS described in Table 2 as regular daily maintenance therapy for at least one month; * Has a rescue SABA containing inhaler that they have used on average at least once a month. * Able to provide consent in English for the feasibility study or in English or Spanish for the full study. Exclusion Criteria: * Life expectancy \<2 years; * COPD diagnosis unless: a) they were a never smoker; OR b) former smoker with normal pulmonary function tests (PFT; FEV1/FVC ratio of \>70%); OR c) current smoker with normal PFTs within 24 months of enrollment; OR d) current or former smoker with obstruction on PFTs (FEV1/FVC ratio of \<70% but who demonstrates BOTH \>12% acute bronchodilator reversibility AND a normal diffusing capacity both within 24 months of enrollment (criteria successfully used in PREPARE); * Use of single inhaler product that contains an ICS, LAMA and LABA or one containing both LABA and LAMA within 1 month of enrollment; * Use of current biologic for less than 6 months; * Known allergy to any of the components of the intervention; * Coexisting lung disease (e.g. Cystic Fibrosis, connective tissue disease (unless asthma preceded diagnosis of connective tissue disease by at least 2 years), prematurity-born at 32 weeks or sooner, organ transplantation, bronchiectasis, sarcoid, and obliterative bronchiolitis, among others) * Has been in an asthma drug treatment trial in past 60 days or within 5 half-lives, whichever is longer, prior to study visit. * Living in household with someone already enrolled in the study. * Using daily or every other day oral corticosteroids for asthma or any other condition * An AEX in the prior 4 weeks * History of bronchial thermoplasty in prior 6 months * Poorly or uncontrolled atrial fibrillation * Not on stable asthma medications for at least 1 month prior to enrollment * Using doses of ICS/LABA lower than the minimum below: * Budesonide 320 ug, * Fluticasone Advair Diskus/ Wixela 200-250 ug Advair HFA 180-230ug Airduo 110-113 ug Breo 100 ug * Mometasone 200 ug
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
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Duke University
Durham, North Carolina, 27705, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19122, United States
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University of Wisconsin Madison
Madison, Wisconsin, 53792, United States
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Washington University
St Louis, Missouri, 63110, United States
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Yale University
New Haven, Connecticut, 06510, United States
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