CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,220 enrolled
Drug / intervention
PARTICS using QVARdrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02995733
NCT02995733Phase 4Completed

Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations

Brigham and Women's Hospital·interventional·Posted Dec 16, 2016·Updated Jan 19, 2023

In Brief

A Phase 4 clinical trial evaluating PARTICS using QVAR for Asthma. Completed, enrolled 1,220 participants across 20 sites in 2 countries.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesPuerto Rico, United States

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 16, 2016
Enrollment StartNov 27, 2017
Primary CompletionApr 30, 2021
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 9.5 years ago

Interventions

PARTICS using QVARdrug

Patient takes inhaled corticosteroid at the time of rescue inhaler use