Comparative Effectiveness of Azithromycin Relative to Roflumilast in Individuals With Uncontrolled Chronic Obstructive Pulmonary Disease Despite Triple Inhaled Therapy

    Basic Details
    Date Posted
    Tuesday, June 28, 2022
    Status
    Protocol in preparation
    Medical Product
    azithromycin
    roflumilast
    Health Outcome(s)
    hospitalization and death
    Description

    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.

    Additional Details
    FDA Center
    CDER
    Time Period
    March 1, 2011 - December 31, 2018
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    Patients at high risk for COPD exacerbations
    Data Sources
    Sentinel Distributed Database (SDD)
    Workgroup Leader(s)

    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

    Workgroup Members

    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