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NCT02995733 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
Phase 4
Development phase
1,220
Enrollment target

NCT02995733 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 1,220 participants.

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The verdict

NCT02995733, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
Phase 4
Development phase
1,220 participants
Enrollment target

Study Summary

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 ex

Interventions

  • DRUG PARTICS using QVAR

Trial Details

FieldValue
Enrollment Target 1,220 participants
Start Date 2017-11-27
Est. Completion 2021-04-30
Phase Phase 4

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT02995733

The ClinicalTrials.gov registry entry for NCT02995733 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which PARTICS using QVAR is the first listed.

NCT02995733 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02995733 about?

NCT02995733 is a clinical study titled "Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief". 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 ga...

What is the current status of trial NCT02995733?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,220 participants. The study started on 2017-11-27. Estimated completion is 2021-04-30.

What interventions are being tested in trial NCT02995733?

The interventions under investigation include: PARTICS using QVAR (DRUG).

Who is sponsoring clinical trial NCT02995733?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.