MART vs ICS Add-On for Asthma
(iCARE Trial)
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.12345Why 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.46789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either the MART or PARTICS strategy and instructed on medication use
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
4
Treatment groups
Active Control
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.
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
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Citations
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] ...
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.
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 ...
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-RelieverBudesonide/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 ...
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.
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.
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-adultsInitiating 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 ...
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