Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

Description

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.

Conditions

Chronic Obstructive Pulmonary Disease Severe, Chronic Bronchitis

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Study Overview

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Study Details

Study overview

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.

Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

Condition
Chronic Obstructive Pulmonary Disease Severe
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama, Birmingham, Alabama, United States, 35233

Sacramento

University of California, Davis Health, Sacramento, California, United States, 95817

Chicago

Northwestern, Chicago, Illinois, United States, 60611

Chicago

University of Illinois, Chicago, Chicago, Illinois, United States, 60612

Glenview

NorthShore Hospital, Glenview, Illinois, United States, 60026

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Kansas City

University of Kansas, Kansas City, Kansas, United States, 66160

New Orleans

Ochsner Medical Center, New Orleans, Louisiana, United States, 70121

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

Springfield

Baystate Health, Springfield, Massachusetts, United States, 01199

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Jerry Krishnan, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Illinois Chicago

Robert Wise, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins School of Medicine

Study Record Dates

2026-05-01