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Clinical trialNCT02995733CompletedPhase 4Interventional

Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief

SponsorBrigham and Women's HospitalEnrollment1,220Asthma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Asthma imposes a significant burden in the US in terms of morbidity, costs to society, individual suffering, loss of productivity and mortality. African Americans (AA) and Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite national guidelines for asthma treatment, the gap between these groups and whites has been stable or widening. The need for pragmatic research to address the continuing burden is widely recognized. Patients use asthma reliever inhalers to provide immediate relief of symptoms. Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used regularly to prevent symptoms and attacks. Guidelines suggest that they be used daily, on a fixed basis, in all but the mildest asthma. However, adherence by patients and implementation of evidence-based guideline recommendations by clinicians has been poor. Gap analysis suggests that it is difficult to improve adherence to the current recommendations without complex and resource-intensive interventions. Studies have examined symptom-activated use of ICS triggered by use of a reliever medication. The Investigators call this approach PARTICS - Patient Activated Reliever-Triggered Inhaled CorticoSteroid. Explanatory, non-real world studies suggest that PARTICS can produce up to 50% reductions in asthma attacks compared with usual care, while reducing ICS use by half or more. These studies have been performed in pre-selected populations, which represent less than 5% of asthma patients. The previous studies have been done with repeated education and adherence checks in both the intervention and control arms. The investigators have consulted with AA and H/L patients, health care providers, leaders of professional societies, advocacy groups, health policy leaders, pharmacists, and pharmaceutical manufacturers. All groups have indicated that asthma decision making would be changed if we demonstrated that implementing PARTICS improves important asthma outcomes such as reducing exacerbations. The Investigators have designed a study with the stakeholders to determine whether PARTICS can improve outcomes that are important to patients when superimposed on a background provider-educated standard of care through the Asthma IQ system. The Investigators propose a study entitled PREPARE: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations. The Investigators aim to determine whether PARTICS can reduce asthma morbidity in AA and H/L.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

20 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico
  • University of Puerto Rico

    San Juan, Puerto Rico

United States
  • University of Alabama

    Birmingham, Alabama, United States

  • University of Southern California

    Los Angeles, California, United States

  • Denver Health and Hospital Authority

    Denver, Colorado, United States

  • Yale University

    New Haven, Connecticut, United States

  • University of Florida

    Gainesville, Florida, United States

  • University of Miami

    Miami, Florida, United States

  • Grace Medical Home

    Orlando, Florida, United States

  • University of Central Florida

    Orlando, Florida, United States

  • University of South Florida

    Tampa, Florida, United States

  • University of Illinois- Chicago

    Chicago, Illinois, United States

  • Baystate Health Center

    Springfield, Massachusetts, United States

  • Mt. Sinai

    New York, New York, United States

  • Montefiore

    The Bronx, New York, United States

  • University of North Carolina

    Chapel Hill, North Carolina, United States

  • Atrium Health

    Charlotte, North Carolina, United States

  • Duke University

    Durham, North Carolina, United States

  • Metrohealth

    Cleveland, Ohio, United States

  • Temple University

    Philadelphia, Pennsylvania, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PARTICS using QVAR
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
27 Nov 2017
Primary completion
30 Apr 2021
Completion
30 Apr 2021
Last update posted
19 Jan 2023
Registered enrollment
1,220
Registry id
NCT02995733

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.