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NCT06596512 · ClinicalTrials.gov registry record · NA
Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
A NA study, sponsored by Brigham and Women's Hospital.
- Not yet
- Registry status
- NA
- Development phase
- 4,100
- Enrollment target
NCT06596512 is a NA study that has not yet begun recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 4,100 participants.
The verdict
NCT06596512, a NA study, has not yet begun recruiting, sponsored by Brigham and Women's Hospital.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 4,100 participants
- Enrollment target
Study Summary
The goal of this trial test two known effective asthma strategies. Treatment guidelines recommend combination therapy of inhaled corticosteroids (ICS) with a long-acting beta-agonist (LABA) inhaled medications. This strategy is known as MART (maintenance and reliever therapy). The second strategy is PARTICS (patient activated reliever triggered ICS) strategy instructs patients to use an ICS metered dose inhaler (ICS) each time they use their rescue inhaler. In addition, they are instructed to take 5 puffs of the ICS after each rescue nebulizer use. PARTICS has been shown to reduce exacerbations, increase asthma control and quality of life, however, the question remains if PARTICS is as effective as MART and therefore be an alternative to MART. This trial will test PARTICS and MART head-to-head. The trial will include adults with moderate-to-severe asthma at risk for an asthma exacerbation, currently using a combination ICS. The main questions aim to answer: * Is PARTICS as effective as SMART? * Might PARTICS be more effective than SMART? Is the relative effectiveness of PARTICS versus SMART affected by frequent nebulizer use for asthma relief? * Do PARTICS and SMART diverge in terms of their effectiveness on differing asthma outcomes important to patients? * Do socioeconomic factors affect the relative effectiveness of PARTICS and SMART? Researchers will compare non frequent nebulizer (NFN) users - less than once a week to frequent nebulizer users - once a week or more, to assess whether the PARTICS strategy is ono-inferior (or superior to the MART strategy in reducing exacerbations, (primary outcome), increasing asthma control and quality of life and decrease days lost from work/school or usual activities. Most participants will be consented, enrolled, and randomized virtually, others will be consented, enrolled and randomized in person. Once randomized they will be instructed on how to use the prescribed medication: * Participants randomized to MART will be i
Interventions
- DRUG PARTICS using a single ICS add on
- DRUG MART
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,100 participants |
| Start Date | 2026-07 |
| Est. Completion | 2030-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06596512
The ClinicalTrials.gov registry entry for NCT06596512 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 4,100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PARTICS using a single ICS add on is the first listed.
NCT06596512 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06596512 about?
NCT06596512 is a clinical study titled "Improving the Quality of Care for Asthma Patients at Risk of Exacerbations". The goal of this trial test two known effective asthma strategies. Treatment guidelines recommend combination therapy of inhaled corticosteroids (ICS) with a long-acting beta-agonist (LABA) inhaled medications. This strategy is known as MART (maintenance and reliever therapy). The second strategy is...
What is the current status of trial NCT06596512?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 4,100 participants. The study started on 2026-07. Estimated completion is 2030-12.
What interventions are being tested in trial NCT06596512?
The interventions under investigation include: PARTICS using a single ICS add on (DRUG), MART (DRUG).
Who is sponsoring clinical trial NCT06596512?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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