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Improving the Quality of Care for Asthma Patients at Risk of Exacerbations

NCT06596512 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4100

Last updated 2026-03-12

No results posted yet for this 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 instructed to use the prescribed ICS/LABA for maintenance and as needed for rescue.
* Participants randomized to PARTICS will be instructed to use the prescribed ICS each time they use their rescue inhaler and take 5 puffs of the newly prescribed ICS after each rescue nebulizer use.
* Participants will be followed for 16 months by monthly survey.

Conditions

  • Asthma
  • Asthma Chronic
  • Asthma Severe Persistent With Exacerbation
  • Asthma Moderate Persistent With Exacerbation

Interventions

DRUG

PARTICS using a single ICS add on

Participants randomized to PARTICS who use a nebulizer less than once a week are instructed to use the study prescribed ICS each time they use their rescue inhaler and take 5 puffs of the newly prescribed ICS after each rescue nebulizer use.

DRUG

MART

Participants are instructed to use prescribed study ICS/LABA for maintenance and as needed for rescue.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2030-05-31
Completion
2030-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06596512 on ClinicalTrials.gov