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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: Clinical Trial NA study, sponsored by Brigham and Women's Hospital.
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, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (192% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The primary outcome is annualized rate of asthma exacerbations, defined as 72 hours of parenteral or oral corticosteroids to treat asthma symptoms or an asthma related-hospitalization. Participants are asked on their monthly surveys if they have had an exacerbation requiring at least 3 days of oral steroids or a hospitalization. If the participant answers yes to these questions, the clinical coordinating center contacts the site study coordinator to confirm an exacerbation in the patients EHR. 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 |
What is known before NCT06596512 opens enrollment
NCT06596512 is an interventional study that assigns participants to a tested intervention. Its 4,100 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (192% higher).
The record links to 0 conditions, and to 2 interventions - of which PARTICS using a single ICS add on is the first listed.
NCT06596512 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06596512's enrollment target sits among peer trials
4,100 32nd of 2000 higher than 1,969 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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