Details
As part of the third task specified in the Chronic Obstructive Pulmonary Disease (COPD), Asthma, and Respiratory Disease Effectiveness (CARE) for 21st Century Cures project, we will perform a comparative effectiveness study to determine whether azithromycin is non-inferior or superior to roflumilast in patients with COPD with a history of inhaled medication use and high risk for exacerbations. The objective of the study is the prospective trial emulation of the randomized-controlled trial RELIANCE, using real world observational data from the Sentinel Distributed Database (SDD). RELIANCE is an ongoing, parallel, pragmatic, non-inferiority trial comparing the efficacy of roflumilast versus azithromycin in preventing hospitalization or death among patients at high risk for COPD exacerbations. We will use cohort, exposure, and outcome definitions from earlier CARE analyses to inform our propensity score matched analysis evaluating outcomes of hospitalization and COPD exacerbations.
This protocol was posted for public comment from September 1, 2022, through September 15, 2022. The public comment period is now closed. No comments were received.
Additional Information
Contributors
Sruthi Adimadhyam, PhD, MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Robert Busch, MD, MMSc; Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Amanda Carruth, MPH; Inna Dashevsky, MS; Judith C. Maro, PhD, MS; Kshema Nagavedu, MPH; Jennifer W Thompson, MPP; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Kenneth Quinto, MD, MPH; Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Yunzhao Ren, MD; Division of Cancer Pharmacology, US Food and Drug Administration, Silver Spring, MD
Efe Eworuke, PhD; Marie Bradley, PhD, MScPH, MPharm; Yan Li, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Sally Seymour, MD; Andrew Clerman, MD; Stacy Chin, MD; Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Beltsville, MD
Zhong Wang, PhD; Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
Rongmei Zhang; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD