MART vs ICS Add-On for Asthma

(iCARE Trial)

Recruiting at 5 trial locations

Overseen By Nancy Maher, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must be taking: ICS/LABA

Must not be taking: ICS/LAMA/LABA

Disqualifiers: COPD, Coexisting lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 months

4100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it seems you must be on a stable asthma medication regimen for at least one month before joining. You will be using a new prescribed medication as part of the trial.

What data supports the effectiveness of the drug MART for asthma?

Research shows that using inhaled corticosteroids (ICS) with formoterol as both a maintenance and reliever therapy (MART) improves asthma outcomes by reducing exacerbations and improving control compared to other treatments. ^{1 2 3 4 5}

Is MART therapy safe for asthma patients?

MART therapy, which combines formoterol and inhaled corticosteroids (ICS), has been shown to reduce asthma exacerbations and improve asthma control. While there is some debate about the safety of long-acting beta₂-agonists (LABAs) like formoterol when used regularly, studies have not shown an increased risk of serious adverse events when used in combination with ICS. ^{1 3 6 7 8}

How is the MART treatment for asthma different from other treatments?

MART (Maintenance and Reliever Therapy) is unique because it combines both maintenance and reliever medication in a single inhaler, which can simplify treatment and improve adherence by reducing the number of inhalers a patient needs to use. This approach uses a combination of inhaled corticosteroids (ICS) and formoterol, a long-acting beta-2 agonist, to effectively manage asthma symptoms and reduce exacerbations. ^{1 3 4 8 9}

Eligibility Criteria

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.

Inclusion Criteria

I can give consent in English for the study, or in both English and Spanish for the full study.

I have been diagnosed with asthma for at least one year.

I've had a severe asthma attack needing steroids or hospital stay in the last year.

Exclusion Criteria

I have not had bronchial thermoplasty in the last 6 months.

Living in household with someone already enrolled in the study

Known allergy to any components of the intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the MART or PARTICS strategy and instructed on medication use

16 months

Monthly surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MART
• PARTICS

Trial Overview 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.

Participant Groups

Group I: PARTICS - Non Frequent Nebulizer Users Active Control 1 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 User Active Control 1 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 Therapy Active Control 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

References

1. England pubmed.ncbi.nlm.nih.gov

A network meta-analysis of the association between patient traits and response to regular dosing with ICS/long-acting β2-agonist plus short-acting β2 agonist reliever or maintenance and reliever therapy for asthma. [2023]

2. Turkey pubmed.ncbi.nlm.nih.gov

Stepwise Approach in Asthma Revisited 2023: Expert Panel Opinion of Turkish Guideline of Asthma Diagnosis and Management Group. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Budesonide/formoterol maintenance and reliever therapy versus fluticasone/salmeterol fixed-dose treatment in patients with COPD. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Maintenance and Reliever Therapy Using Inhaled Corticosteroid-Formoterol in Asthmatics. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Age-dependent deterioration of peak inspiratory flow with two kinds of dry powder corticosteroid inhalers (Diskus and Turbuhaler) and relationships with asthma control. [2011]

6. England pubmed.ncbi.nlm.nih.gov

Inhaled steroids with and without regular salmeterol for asthma: serious adverse events. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of Two Therapies on Asthma Control in Children. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Today's improvement in asthma treatment: role of MART and Easyhaler. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Single inhaler maintenance and reliever therapy in pediatric asthma. [2020]