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Asthma showdown: which inhaler strategy wins?

NCT ID NCT06596512

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 4,100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 75 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: * 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.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19122, United States

  • University of Wisconsin Madison

    Madison, Wisconsin, 53792, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Yale University

    New Haven, Connecticut, 06510, United States

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