AsthmaiCARENCT06596512
Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
A study testing PARTICS using a single ICS add on and MART in people with Asthma and Asthma Chronic, run by Brigham and Women's Hospital at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma, Asthma Chronic, Asthma Severe Persistent With Exacerbation
- What is being tested?
- PARTICS using a single ICS add on and MART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,100 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Brigham and Womens Hospital
Boston, Massachusetts, 02115
Jean Kruse, BA, 617-732-8274, Jkruse@mgb.org
Duke University
Durham, North Carolina, 27705
University of Wisconsin Madison
Madison, Wisconsin, 53792
Yale University
New Haven, Connecticut, 06510
University of Pennsylvania
Philadelphia, Pennsylvania, 19122
Washington University
St Louis, Missouri, 63110
About this study
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.
Read more
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.
Read the detailed description
Asthma affects 25 million people in the USA with a disproportionate effect on African American/Black (AA/B) and Hispanic/Latinx (H/L) patients. Inhaled corticosteroids are the backbone of asthma therapy. A so-called SMART (Single Maintenance And Reliever Therapy) approach to ICS therapy has been recommended by US and international guidelines for patients with moderate to severe asthma, because it has been shown in multiple studies to reduce asthma exacerbations. However, these studies have been explanatory, with narrow entry criteria, have only been performed ex- US (with a formulation not available in the US), and have not included significant numbers of AA/B and H/L patients.
Further, there are significant barriers to implementation which include those related to patient patterns of concomitant medication use and beliefs. In a PCORI-funded pragmatic study in 1200 AA/B and H/L patients with asthma, designed with patient partners, we studied an alternative approach we call PARTICS (Patient Activated Reliever Triggered ICS). We reported, in this study published in the New England Journal of Medicine in 2022, that we not only reduced asthma exacerbations, we also improved other outcomes important to patients including asthma control, quality of life and days lost from school, work or usual activities. Our patient advisors have published on their positive experience and other advisors have collaborated with us to publish 9 additional papers which include such topics as an exploration of how socioeconomic factors affect asthma outcomes and how to simply identify patients at risk for asthma exacerbations, among additional topics. Both SMART and PARTICS have advantages and drawbacks. As seen in letters of support from the heads of the US and international guidelines for asthma treatment committees, the lack of direct comparison between the two represents a major gap in knowledge required to formulate best-care practice recommendations.
Specifically, it is unclear as to what degree one approach can substitute for the other and whether they differentially affect distinct domains of asthma outcomes. In collaboration with our advisors, we therefore propose iCARE (Improving the Quality of Care for Asthma patients at Risk of Exacerbations), a large pragmatic study to directly compare SMART to PARTICS in diverse populations and across multiple domains. The study results, regardless of outcome, will help guide the approach to patient-centered asthma care.
- Conditions
- Asthma, Asthma Chronic, Asthma Severe Persistent With Exacerbation, Asthma Moderate Persistent With Exacerbation
- Being tested
- PARTICS using a single ICS add on, MART
- Keywords
- ICS reliever therapy, Decrease exacerbations, iCARE
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARTICS using a single ICS add onDrug
Also called Patient Activated Reliever Triggered ICS
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.
MARTDrug
Participants are instructed to use prescribed study ICS/LABA for maintenance and as needed for rescue.
| Study group | Role | What they receive |
|---|---|---|
| PARTICS - Non Frequent Nebulizer Users | Active comparator | 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. Receives: Drug: PARTICS using a single ICS add on |
| PARTICS - Frequent Nebulizer User | Active comparator | 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 Receives: Drug: PARTICS using a single ICS add on |
| MART (non frequent nebulizer users) - MART strategy - Maintenance and Reliever Therapy | Active comparator | 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. Receives: Drug: MART |
| MART (frequent nebulizer users) | Active comparator | 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. Receives: Drug: MART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbations
The primary outcome is annualized rate of asthma exacerbations, defined as 72 hours of parenteral or oral corticosteroids to treat asthma symptoms or an asthma related-hospitalization. Participants are asked on their monthly surveys if they have had an exacerbation requiring at least 3 days of oral steroids or a hospitalization. If the participant answers yes to these questions, the clinical coordinating center contacts the site study coordinator to confirm an exacerbation in the patients EHR. If there is no record of an exacerbation in the EHR, the CCC contacts the patient for details. The information is entered into an exacerbation database and is reviewed separately by two investigators. If they are in agreement, the outcome is recorded (exacerbation yes or exacerbation no). If they do not agree or are unable to definitively determine if the patient had an exacerbation or not, the information goes to the adjudication committee of 3 for determination.
Measured: Exacerbation information will be collected via monthly survey for 16 months.
Secondary outcomes (3)
Asthma Control over time
Asthma control represents the degree to which impairment (impact of asthma on patient's daily life) is minimized and the goals of therapy are met. The Asthma Control Test is a participant-administered tool for assessing the level of asthma control. Total scores range from 5 to 25, with a score of 20 to 25 indicating well-controlled asthma, a score of 16 to 19 indicating asthma that was not well controlled, and a score of 5 to 15 indicating very poorly controlled asthma. The minimal clinically important difference is 3 points
Measured: Monthly for 16 months
Asthma Symptom Utility Index (ASUI), Preference based quality of life
The ideal outcome measure for any comparative effectiveness analysis captures the risks and benefits for each of the interventions from the patient's point of view. The use of a preference-based instrument, the Asthma Symptom Utility Index (ASUI), captures this important information. The Asthma Symptom Utility Index is a participant-administered tool for assessing preference-based quality of life. Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The minimal clinically important difference is 0.09.
Measured: Monthly for 16 months
Days Lost Per Year From School/Work or Usual Activities
Defined as days not able to work or go to school because of asthma symptoms OR days not able to carry out usual activities due to asthma
Measured: Monthly for 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startJul 2026 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 4,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Elliot Israel, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596512
- Sponsor's protocol ID
- 2024P001955
- Acronym
- iCARE
- Status last verified
- Jan 2026
- First submitted
- 11 Sep 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data and data dictionary.
Publications
Israel E, Cardet JC, Carroll JK, Fuhlbrigge AL, Pace WD, Maher NE, She L, Rockhold FW, Fagan M, Forth VE, Hernandez PA, Manning BK, Rodriguez-Louis J, Shields JB, Coyne-Beasley T, Kaplan BM, Rand CS, Morales-Cosme W, Wechsler ME, Wisnivesky JP, White M, Yawn BP, McKee MD, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang KL, Pinto-Plata V, Stranges PM, Hurley LP, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy K, Pasarica M, Calderon-Candelario RA, Tapp H, Baydur A. A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial. Contemp Clin Trials. 2021 Feb;101:106246. doi: 10.1016/j.cct.2020.106246. Epub 2020 Dec 11.
PubMed 33316456Expert Panel Working Group of the National Heart, Lung, and Blood Institute (NHLBI) administered and coordinated National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC); Cloutier MM, Baptist AP, Blake KV, Brooks EG, Bryant-Stephens T, DiMango E, Dixon AE, Elward KS, Hartert T, Krishnan JA, Lemanske RF Jr, Ouellette DR, Pace WD, Schatz M, Skolnik NS, Stout JW, Teach SJ, Umscheid CA, Walsh CG. 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. J Allergy Clin Immunol. 2020 Dec;146(6):1217-1270. doi: 10.1016/j.jaci.2020.10.003.
PubMed 33280709Reddel HK, Bacharier LB, Bateman ED, Brightling CE, Brusselle GG, Buhl R, Cruz AA, Duijts L, Drazen JM, FitzGerald JM, Fleming LJ, Inoue H, Ko FW, Krishnan JA, Levy ML, Lin J, Mortimer K, Pitrez PM, Sheikh A, Yorgancioglu AA, Boulet LP. Global Initiative for Asthma Strategy 2021: Executive Summary and Rationale for Key Changes. J Allergy Clin Immunol Pract. 2022 Jan;10(1S):S1-S18. doi: 10.1016/j.jaip.2021.10.001. Epub 2021 Oct 28.
PubMed 34718211Imam SF, Zafar S, Oppenheimer JJ. Single maintenance and reliever therapy in treatment of asthma exacerbations. Ann Allergy Asthma Immunol. 2022 Dec;129(6):703-708. doi: 10.1016/j.anai.2022.07.024. Epub 2022 Jul 29.
PubMed 35914659Sobieraj DM, Weeda ER, Nguyen E, Coleman CI, White CM, Lazarus SC, Blake KV, Lang JE, Baker WL. Association of Inhaled Corticosteroids and Long-Acting beta-Agonists as Controller and Quick Relief Therapy With Exacerbations and Symptom Control in Persistent Asthma: A Systematic Review and Meta-analysis. JAMA. 2018 Apr 10;319(14):1485-1496. doi: 10.1001/jama.2018.2769.
PubMed 29554195Patel M, Pilcher J, Pritchard A, Perrin K, Travers J, Shaw D, Holt S, Harwood M, Black P, Weatherall M, Beasley R; SMART Study Group. Efficacy and safety of maintenance and reliever combination budesonide-formoterol inhaler in patients with asthma at risk of severe exacerbations: a randomised controlled trial. Lancet Respir Med. 2013 Mar;1(1):32-42. doi: 10.1016/S2213-2600(13)70007-9. Epub 2013 Mar 4.
PubMed 24321802
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
- ClinicalTrials.gov ID
- NCT06596512
- Acronym / sponsor ID
- iCARE / 2024P001955
- Conditions
- Asthma, Asthma Chronic, Asthma Severe Persistent With Exacerbation, Asthma Moderate Persistent With Exacerbation
- Keywords
- ICS reliever therapy, Decrease exacerbations, iCARE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,100 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jul 2026 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthma affects 25 million people in the USA with a disproportionate effect on African American/Black (AA/B) and Hispanic/Latinx (H/L) patients. Inhaled corticosteroids are the backbone of asthma therapy. A so-called SMART (Single Maintenance And Reliever Therapy) approach to ICS therapy has been recommended by US and international guidelines for patients with moderate to severe asthma, because it has been shown in multiple studies to reduce asthma exacerbations. However, these studies have been explanatory, with narrow entry criteria, have only been performed ex- US (with a formulation not available in the US), and have not included significant numbers of AA/B and H/L patients.
Further, there are significant barriers to implementation which include those related to patient patterns of concomitant medication use and beliefs. In a PCORI-funded pragmatic study in 1200 AA/B and H/L patients with asthma, designed with patient partners, we studied an alternative approach we call PARTICS (Patient Activated Reliever Triggered ICS). We reported, in this study published in the New England Journal of Medicine in 2022, that we not only reduced asthma exacerbations, we also improved other outcomes important to patients including asthma control, quality of life and days lost from school, work or usual activities. Our patient advisors have published on their positive experience and other advisors have collaborated with us to publish 9 additional papers which include such topics as an exploration of how socioeconomic factors affect asthma outcomes and how to simply identify patients at risk for asthma exacerbations, among additional topics. Both SMART and PARTICS have advantages and drawbacks. As seen in letters of support from the heads of the US and international guidelines for asthma treatment committees, the lack of direct comparison between the two represents a major gap in knowledge required to formulate best-care practice recommendations.
Specifically, it is unclear as to what degree one approach can substitute for the other and whether they differentially affect distinct domains of asthma outcomes. In collaboration with our advisors, we therefore propose iCARE (Improving the Quality of Care for Asthma patients at Risk of Exacerbations), a large pragmatic study to directly compare SMART to PARTICS in diverse populations and across multiple domains. The study results, regardless of outcome, will help guide the approach to patient-centered asthma care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PARTICS - Non Frequent Nebulizer Users | Active comparator | Drug: PARTICS using a single ICS add onParticipants 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. |
| PARTICS - Frequent Nebulizer User | Active comparator | Drug: PARTICS using a single ICS add onParticipants 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 |
| MART (non frequent nebulizer users) - MART strategy - Maintenance and Reliever Therapy | Active comparator | Drug: MARTParticipants 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. |
| MART (frequent nebulizer users) | Active comparator | Drug: MARTParticipants 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 may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PARTICS using a single ICS add onAlso: Patient Activated Reliever Triggered ICSParticipants 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 | PARTICS - Frequent Nebulizer User, PARTICS - Non Frequent Nebulizer Users |
| MARTParticipants are instructed to use prescribed study ICS/LABA for maintenance and as needed for rescue. | Drug | MART (frequent nebulizer users), MART (non frequent nebulizer users) - MART strategy - Maintenance and Reliever Therapy |
Primary outcome
Exacerbations
Time frame: Exacerbation information will be collected via monthly survey for 16 months.
The primary outcome is annualized rate of asthma exacerbations, defined as 72 hours of parenteral or oral corticosteroids to treat asthma symptoms or an asthma related-hospitalization. Participants are asked on their monthly surveys if they have had an exacerbation requiring at least 3 days of oral steroids or a hospitalization. If the participant answers yes to these questions, the clinical coordinating center contacts the site study coordinator to confirm an exacerbation in the patients EHR. If there is no record of an exacerbation in the EHR, the CCC contacts the patient for details. The information is entered into an exacerbation database and is reviewed separately by two investigators. If they are in agreement, the outcome is recorded (exacerbation yes or exacerbation no). If they do not agree or are unable to definitively determine if the patient had an exacerbation or not, the information goes to the adjudication committee of 3 for determination.
3 secondary outcomes
Asthma Control over time
Time frame: Monthly for 16 months
Asthma Symptom Utility Index (ASUI), Preference based quality of life
Time frame: Monthly for 16 months
Days Lost Per Year From School/Work or Usual Activities
Time frame: Monthly for 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 33316456Israel E, Cardet JC, Carroll JK, Fuhlbrigge AL, Pace WD, Maher NE, She L, Rockhold FW, Fagan M, Forth VE, Hernandez PA, Manning BK, Rodriguez-Louis J, Shields JB, Coyne-Beasley T, Kaplan BM, Rand CS, Morales-Cosme W, Wechsler ME, Wisnivesky JP, White M, Yawn BP, McKee MD, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang KL, Pinto-Plata V, Stranges PM, Hurley LP, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy K, Pasarica M, Calderon-Candelario RA, Tapp H, Baydur A. A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial. Contemp Clin Trials. 2021 Feb;101:106246. doi: 10.1016/j.cct.2020.106246. Epub 2020 Dec 11.
- Background: PubMed 33280709Expert Panel Working Group of the National Heart, Lung, and Blood Institute (NHLBI) administered and coordinated National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC); Cloutier MM, Baptist AP, Blake KV, Brooks EG, Bryant-Stephens T, DiMango E, Dixon AE, Elward KS, Hartert T, Krishnan JA, Lemanske RF Jr, Ouellette DR, Pace WD, Schatz M, Skolnik NS, Stout JW, Teach SJ, Umscheid CA, Walsh CG. 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. J Allergy Clin Immunol. 2020 Dec;146(6):1217-1270. doi: 10.1016/j.jaci.2020.10.003.
- Background: PubMed 34718211Reddel HK, Bacharier LB, Bateman ED, Brightling CE, Brusselle GG, Buhl R, Cruz AA, Duijts L, Drazen JM, FitzGerald JM, Fleming LJ, Inoue H, Ko FW, Krishnan JA, Levy ML, Lin J, Mortimer K, Pitrez PM, Sheikh A, Yorgancioglu AA, Boulet LP. Global Initiative for Asthma Strategy 2021: Executive Summary and Rationale for Key Changes. J Allergy Clin Immunol Pract. 2022 Jan;10(1S):S1-S18. doi: 10.1016/j.jaip.2021.10.001. Epub 2021 Oct 28.
- Background: PubMed 35914659Imam SF, Zafar S, Oppenheimer JJ. Single maintenance and reliever therapy in treatment of asthma exacerbations. Ann Allergy Asthma Immunol. 2022 Dec;129(6):703-708. doi: 10.1016/j.anai.2022.07.024. Epub 2022 Jul 29.
- Background: PubMed 29554195Sobieraj DM, Weeda ER, Nguyen E, Coleman CI, White CM, Lazarus SC, Blake KV, Lang JE, Baker WL. Association of Inhaled Corticosteroids and Long-Acting beta-Agonists as Controller and Quick Relief Therapy With Exacerbations and Symptom Control in Persistent Asthma: A Systematic Review and Meta-analysis. JAMA. 2018 Apr 10;319(14):1485-1496. doi: 10.1001/jama.2018.2769.
- Background: PubMed 24321802Patel M, Pilcher J, Pritchard A, Perrin K, Travers J, Shaw D, Holt S, Harwood M, Black P, Weatherall M, Beasley R; SMART Study Group. Efficacy and safety of maintenance and reliever combination budesonide-formoterol inhaler in patients with asthma at risk of severe exacerbations: a randomised controlled trial. Lancet Respir Med. 2013 Mar;1(1):32-42. doi: 10.1016/S2213-2600(13)70007-9. Epub 2013 Mar 4.
- Individual participant dataSharing planned: Yes. Deidentified data and data dictionary.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PARTICS using a single ICS add on and MART in people with Asthma and Asthma Chronic, run by Brigham and Women's Hospital at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Maher, MPH (781-879-0946, nmaher@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbations (time frame: Exacerbation information will be collected via monthly survey for 16 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06596512, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.