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NCT04069312 | RECRUITING | Chronic Obstructive Pulmonary Disease Severe

Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)
Sponsor:

Johns Hopkins University

Brief Summary:

A multi-center, randomized, 72-month, parallel- group, non-inferiority, phase III study to compare the effectiveness of roflumilast (Daliresp, 500 mcg quaque die (QD) or alternate regimen) therapy versus azithromycin (250 mg QD, 500 mg QD three times per week, or alternate regimen) to prevent hospitalization or death in a patients at high risk for COPD exacerbations.

Condition or disease

Chronic Obstructive Pulmonary Disease Severe

Chronic Bronchitis

Intervention/treatment

Roflumilast

Azithromycin

Phase

PHASE4

Detailed Description:

RELIANCE is a U.S.-based pragmatic clinical trial funded by the Patient-Centered Outcomes Research Institute (PCORI) to compare long-term use of roflumilast vs. azithromycin in up to 1,250 patients. It is intended to support hospital efforts to reduce the risk of all-cause hospitalization and reduce pre-mature deaths in individuals with chronic obstructive pulmonary disease (COPD) who have been hospitalized in the prior year for a COPD exacerbation. The COPD Patient Powered Research Network (PPRN) and affiliated investigators will conduct the trial in sites in the U.S. Both roflumilast and azithromycin have been shown to reduce the risk of COPD exacerbations compared to placebo. However, there has not been a head-to-head comparison of the two medications. So, the relative harms and benefits of the two medications are unknown. Eligible patients will be randomized (1:1) to receive either a prescription for roflumilast or a prescription for azithromycin, and will be followed for at least 6 and up to 72 months. The primary endpoint is the combined outcome of all-cause hospitalization or death; the secondary endpoints include premature treatment discontinuation, patient-reported adverse effects, and physical, social, and emotional health. Patients will be enrolled at participating clinical sites and follow up data will be collected via an online patient portal or via a call center. Baseline and outcome data will also be collected from site medical records and administrative/claims databases. Pragmatic, non-inferiority trial using an intention-to-treat analysis to evaluate whether daily azithromycin is non-inferior to daily roflumilast in patients at high risk of COPD exacerbations. The investigators will randomize individual patients to receive prescriptions for roflumilast or azithromycin (1:1 ratio), stratified by site and current smoking status (yes/no).

Study Type : INTERVENTIONAL
Estimated Enrollment : 1250 participants
Masking : NONE
Masking Description : Treatment assignments will be concealed prior to randomization. Once a patient is assigned to receive a treatment, the clinician, Site Coordinator and patient will not be masked. i.e., they will know the treatment assignment
Primary Purpose : OTHER
Official Title : Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)
Actual Study Start Date : 2020-02-11
Estimated Primary Completion Date : 2026-03-01
Estimated Study Completion Date : 2026-05-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patient and treating clinician considering treatment intensification with roflumilast or azithromycin to reduce the risk of COPD exacerbations
  • * Age ≥ 40 years
  • * Current or past smoker of at least 10 pack-years
  • * Diagnosis of severe COPD and associated chronic bronchitis
  • * Hospitalized with a diagnosis of COPD exacerbation or respiratory complications due to COVID 19 in the past 12 months
  • * Current medications include inhaled Long Acting Muscarinic Antagonist (LAMA), Long Acting Beta Agonist (LABA) /LAMA, or Inhaled Corticosteroids (ICS) /LABA
  • * English or Spanish speaking
Exclusion Criteria
  • * Unable or declines to provide informed consent;
  • * Declines to provide social security number or health insurance claims number (as applicable)
  • * History of intolerance to azithromycin or roflumilast that the patient or patient's treating clinician considers sufficiently serious to avoid either treatment option;
  • * Current treatment with long-term (more than 30 days) roflumilast or azithromycin (previous treatment with 1 or more doses of azithromycin or roflumilast is not an exclusion criterion, as long as the patient and clinician are seeking treatment intensification options and would be willing to use azithromycin or roflumilast, as per randomized treatment assignment.)
  • * Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic;
  • * History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
  • * Moderate to severe liver impairment (Child-Pugh B or C)
  • * Current pregnancy
  • * Any other clinician-determined exclusion as per the clinician's clinical practice
Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

Location Details

NCT04069312

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

University of Alabama

Birmingham, Albama, United States, 35233

RECRUITING

United States, California

University of California, Davis Health

Sacramento, California, United States, 95817

RECRUITING

United States, Illinois

Northwestern

Chicago, Illinois, United States, 60611

RECRUITING

United States, Illinois

University of Illinois, Chicago

Chicago, Illinois, United States, 60612

RECRUITING

United States, Illinois

NorthShore Hospital

Glenview, Illinois, United States, 60026

RECRUITING

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

RECRUITING

United States, Kansas

University of Kansas

Kansas City, Kansas, United States, 66160

RECRUITING

United States, Louisiana

Ochsner Medical Center

New Orleans, Louisiana, United States, 70121

RECRUITING

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21287

RECRUITING

United States, Massachusetts

Baystate Health

Springfield, Massachusetts, United States, 01199

RECRUITING

United States, Road cancer

University of Michigan

Ann Arbor, Road cancer, United States, 48109

RECRUITING

United States, Road cancer

Henry Ford Health System

Detroit, Road cancer, United States, 48202

RECRUITING

United States, Missouri

University of Missouri, Kansas City

Kansas City, Missouri, United States, 64108

RECRUITING

United States, New York

Mount Sinai

New York, New York, United States, 10029

RECRUITING

United States, New York

Lenox Hill Hospital/Northwell Health

New York, New York, United States, 10075

RECRUITING

United States, North Carolina

University of North Carolina, School of Medicine

Chapel Hill, North Carolina, United States, 27599

RECRUITING

United States, North Carolina

Duke

Durham, North Carolina, United States, 27705

RECRUITING

United States, Ohio

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

RECRUITING

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Ohio

Ohio State University

Columbus, Ohio, United States, 43210

RECRUITING

United States, Oregon

Kaiser Permanente

Portland, Oregon, United States, 97227

RECRUITING

United States, Pennsylvania

Temple University Hospital

Philadelphia, Pennsylvania, United States, 19140

RECRUITING

United States, Pennsylvania

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, United States, 15213

RECRUITING

United States, Texas

Baylor Scott & White (BSW) Health-North

Dallas, Texas, United States, 75246

RECRUITING

United States, Texas

Houston Methodist Hospital

Houston, Texas, United States, 77030

RECRUITING

United States, Vermont

University of Vermont

Burlington, Vermont, United States, 05401

RECRUITING

United States, Washington

Providence Health and Services

Spocane, Washington, United States, 99204