MART vs ICS Add-On for Asthma

(iCARE Trial)

Not yet recruiting at 6 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two asthma treatment strategies to determine which improves asthma control and quality of life more effectively. The first strategy, Maintenance and Reliever Therapy (MART), uses a combined inhaler for both daily maintenance and rescue. The second strategy, PARTICS, involves using a specific inhaler each time a rescue inhaler is used, with additional doses after using a rescue nebulizer. Adults with moderate-to-severe asthma, who frequently experience asthma attacks and currently use combination inhalers, may be suitable candidates for this trial. Researchers will monitor participants for 16 months to assess the effectiveness of each approach. As an unphased trial, this study provides a unique opportunity to contribute to asthma research and potentially enhance personal asthma management strategies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that MART (Maintenance and Reliever Therapy) is well-tolerated by people with asthma. Research indicates that MART reduces asthma attacks and improves symptom control. Participants using MART reported fewer serious side effects and required less oral corticosteroid medication, which can cause serious side effects if overused.

Studies have also shown that PARTICS (Patient Activated Reliever-Triggered Inhaled Corticosteroid) is well-tolerated. PARTICS effectively lowers the risk of severe asthma attacks compared to using a rescue inhaler alone. Participants reported better asthma control and quality of life with PARTICS.

Both MART and PARTICS use inhaled medications, which are generally considered safe and have long been used for asthma treatment. These medications work directly in the lungs, usually resulting in fewer side effects compared to oral medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MART and PARTICS strategies for asthma because they offer personalized approaches based on nebulizer use frequency. Unlike standard treatments that often involve a fixed dosage of inhaled corticosteroids, the PARTICS strategy allows patients to use inhaled corticosteroids only when needed, right after using a reliever inhaler or nebulizer. This patient-activated method could lead to more responsive asthma management. On the other hand, the MART strategy combines maintenance and reliever therapy into one, using an ICS/LABA combo, which might simplify treatment regimens and improve adherence. These approaches aim to tailor asthma care more closely to individual needs, potentially improving outcomes and quality of life for asthma patients.

What is the effectiveness track record for MART and PARTICS in treating asthma?

Studies have shown that the MART strategy, which combines two medications in one inhaler, reduces asthma flare-ups by about 30% compared to using two separate inhalers. This results in fewer asthma attacks and better daily control. In this trial, some participants will follow the MART strategy. Conversely, the PARTICS method involves using an additional medication with each use of a rescue inhaler, and some studies have shown it can reduce severe asthma attacks by up to 50%. PARTICS has proven especially effective for Black and Latinx patients. Other participants in this trial will follow the PARTICS method. Both methods have strong evidence supporting them, but they function differently. This trial aims to compare the performance of these two strategies against each other. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7460660/

Today's improvement in asthma treatment: role of MART ... In fact, MART is more effective at reducing exacerbations and improving daily asthma control than the same maintenance dose of BUD/FORM plus as-needed SABA [22] ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213219822005943

Effectiveness of Maintenance and Reliever Therapy Using ... This study evaluated the benefits of MART in adult asthmatics and compared them with those of conventional asthma treatment using ICS-LABA plus SABA.

3. lung.org lung.org/blog/asthma-smart-therapy

Cost Analysis of SMART Therapy to Improve Asthma ... Studies show that using a single inhaler reduces the risk of asthma flare-ups by about 30%, compared to using one daily maintenance inhaler plus ...

4. explorationpub.com explorationpub.com/Journals/eaa/Article/100969

Short-term outcomes after implementation of SABA-free ... This data provides real world evidence that the use of MART/AIR with BUD/FORM simultaneously with the elimination of SABA is safe and effective for moderate ...

5. publications.aap.org publications.aap.org/pediatrics/article/154/Supplement%204/S50/200039/Budesonide-Formoterol-Maintenance-and-Reliever

Budesonide/Formoterol Maintenance and Reliever ... RESULTS: At 6 months, the MART group had a lower risk for mild asthma exacerbations (odds ratio 0.32 confidence interval 0.14–0.75) with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12373597/

Real-World Use of MART in Moderate–Severe Asthma Moderate–severe asthma affects a significant proportion of patients and poses challenges in symptom control and exacerbation prevention.

7. annallergy.org annallergy.org/article/S1081-1206(22)00619-6/fulltext

Single maintenance and reliever therapy in treatment ... SMART therapy compared with standard therapy has been found to reduce asthma exacerbation and prolonged time to first exacerbation in multiple trials.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1081120624003636

Adoption and implementation of maintenance and reliever ... Randomized controlled trials have shown that MART leads to a significant reduction in asthma exacerbations, defined as systemic corticosteroid use, ...

9. uptodate.com uptodate.com/contents/initiating-asthma-therapy-and-monitoring-in-adolescents-and-adults

Initiating asthma therapy and monitoring in adolescents and ... Efficacy and safety of maintenance and reliever combination budesonide-formoterol inhaler in patients with asthma at risk of severe ...