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Corticosteroid

PARTICS - Non Frequent Nebulizer Users for Asthma (iCARE Trial)

N/A
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Clinician diagnosis of asthma for ≥1 year;
* Age at enrollment--18-75 years old inclusive;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly for 16 months
Awards & highlights

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.

Who is the study for?
Adults with moderate-to-severe asthma at risk for exacerbations, currently on ICS therapy. The trial is not suitable for individuals who don't meet the asthma severity criteria or are unable to follow the treatment protocols.
What is being tested?
The trial compares two asthma treatments: MART (maintenance and reliever therapy using a combination of inhaled corticosteroids and long-acting beta-agonists) versus PARTICS (patient activated reliever triggered ICS strategy). It aims to determine if PARTICS can match or exceed MART's effectiveness in reducing exacerbations and improving quality of life.
What are the potential side effects?
Potential side effects may include typical reactions to inhaled corticosteroids such as throat irritation, hoarseness, coughing, dry mouth, and possible increased risk of infections. Long-term use might affect bone density or cause other systemic effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly for 16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly for 16 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Exacerbations
Secondary study objectives
Asthma Control over time
Asthma Symptom Utility Index (ASUI), Preference based quality of life
Days Lost Per Year From School/Work or Usual Activities

Trial Design

4Treatment groups
Active Control
Group I: PARTICS - Non Frequent Nebulizer UsersActive Control1 Intervention
Participants who use a nebulizer less than once a week are Non Frequent Nebulizer (NFN) Users. Adding the PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS). Patient will use inhaled corticosteroid at time of reliever inhaler or after reliever nebulizer use.
Group II: PARTICS - Frequent Nebulizer UserActive Control1 Intervention
Participants who use a nebulizer once a week or more are "Frequent Nebulizer Users". Addition of the PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS). Patient will use inhaled corticosteroid at time of rescue inhaler or rescue nebulizer use
Group III: MART (non frequent nebulizer users) - MART strategy - Maintenance and Reliever TherapyActive Control1 Intervention
Participants who use a nebulizer less than once a week are Non Frequent Nebulizer (NFN) Users. MART strategy is a ICS/LABA combination therapy for maintenance and relief.
Group IV: MART (frequent nebulizer users)Active Control1 Intervention
Participants who use a nebulizer once a week or more are Frequent Nebulizer Users. MART strategy is a ICS/LABA combination therapy for maintenance and relief.

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Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
569 Previous Clinical Trials
27,249,409 Total Patients Enrolled
16 Trials studying Asthma
235,066 Patients Enrolled for Asthma
Brigham and Women's HospitalLead Sponsor
1,655 Previous Clinical Trials
11,495,535 Total Patients Enrolled
43 Trials studying Asthma
216,096 Patients Enrolled for Asthma
~2733 spots leftby Apr 2030