Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT06596512

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

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

4100

Start Date

2026-07

Completion Date

2030-12

Last Updated

2026-03-12

Healthy Volunteers

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.

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

Locations (6)

Yale University

New Haven, Connecticut, United States

Brigham and Womens Hospital

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Duke University

Durham, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Wisconsin Madison

Madison, Wisconsin, United States