Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)
PI(s): Jerry A. Krishnan, MD, PhD
PaTH Protocol PI(s): TBD
Purpose: Chronic obstructive pulmonary disease (COPD) affects 15 million Americans and leads to about 700,000 hospitalizations in the United States each year. Clinical trials suggest long-term use of roflumilast or azithromycin significantly reduces the risk of these exacerbations, but no studies have directly compared the two in patients with COPD.
Goal(s): To determine the side effects of roflumilast or azithromycin and see which treatment better prevents hospitalization.
Study Design: Pragmatic Randomized Clinical Trial. Adults with severe COPD related to chronic bronchitis who are current or past smokers and have been hospitalized for COPD exacerbation in the past 12 months will be randomly assigned roflumilast or azithromycin and followed up to 36 months.
PCORnet Partners: pending
PaTH Partners: pending
Sponsor: PCORI
Coordinating Center: University of Illinois at Chicago
How to Participate: This study has not yet started. Information will be provided when it is available.