Project Summary
Chronic obstructive pulmonary disease (COPD) affects at least 15 million Americans and is the third leading cause of death in the United States. COPD is disproportionately prevalent in elderly, low-income, and minority populations. COPD exacerbations are often debilitating, disrupting the lives of patients and their caregivers for days to weeks or longer. COPD exacerbations lead to about 700,000 hospitalizations in the United States each year. Results from clinical trials and the recently published clinical guidelines indicate that long-term use of either roflumilast or azithromycin significantly reduces the risk of chronic obstructive pulmonary disease (COPD) exacerbations. No studies to date have directly compared long-term roflumilast to azithromycin in patients with COPD, so it is unclear how well they work when compared to each other.
Based on these observations, the COPD Patient-Powered Research Network (PPRN), part of PCORnet, is leading a broad-based collaborative to conduct a large pragmatic trial to evaluate chronic roflumilast versus azithromycin therapy for the prevention of COPD exacerbations (Roflumilast or Azithromycin to Prevent COPD Exacerbations [RELIANCE] Study). RELIANCE will enroll 3,200 adults who have been hospitalized for COPD in the past 12 months. Participants will get a prescription for either azithromycin or roflumilast from their physicians (1,600 patients in each arm). The RELIANCE study is designed to answer the following questions:
- Which treatment will help me avoid another hospitalization?
- Which treatment is best if I’m a smoker? What if I have quit smoking?
- What side effects can I expect if I use azithromycin? What if I use roflumilast?
- Which treatment will help me maintain my physical, mental, and social well-being?
The primary study outcome is all-cause hospitalization or death. Secondary outcomes are patient-reported measures of physical function, problems with sleep, fatigue, anxiety, and ability to perform usual activities, measured using the NIH-PROMIS instruments. Participants will be followed up for a period of 6 months (minimum) to 36 months (maximum).
Both chronic roflumilast and azithromycin offer the potential to substantially reduce the burden associated with COPD exacerbations, but need to be compared in a head-to-head trial in “real-world” clinical populations. The simplicity of the study interventions (medications already in use) and strong support and involvement of relevant stakeholders (including patients, caregivers, clinicians, professional societies, and others) will greatly facilitate the sustainability, scalability, and impact of implementing study findings in real-world settings.
Project Details
Information *All proposed projects are approved subject to a programmatic and budgetary review by PCORI, and the acceptance of PCORI’s contract terms and conditions.