ACTIVE_NOT_RECRUITING

Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

Conditions

Chronic Obstructive Pulmonary Disease Severe Chronic Bronchitis Chronic Obstructive Pulmonary Disease COPD Roflumilast Daliresp Azithromycin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

Quick Facts

Study Start:2020-02-11

Study Completion:2026-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04069312

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.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Jerry Krishnan, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Illinois Chicago

Robert Wise, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Study Locations (Sites)

University of Alabama

Birmingham, Alabama, 35233

United States

University of California, Davis Health

Sacramento, California, 95817

United States

Northwestern

Chicago, Illinois, 60611

United States

University of Illinois, Chicago

Chicago, Illinois, 60612

United States

NorthShore Hospital

Glenview, Illinois, 60026

United States

University of Iowa

Iowa City, Iowa, 52242

United States

University of Kansas

Kansas City, Kansas, 66160

United States

Ochsner Medical Center

New Orleans, Louisiana, 70121

United States

Johns Hopkins University

Baltimore, Maryland, 21287

United States

Baystate Health

Springfield, Massachusetts, 01199

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

University of Missouri, Kansas City

Kansas City, Missouri, 64108

United States

Mount Sinai

New York, New York, 10029

United States

Lenox Hill Hospital/Northwell Health

New York, New York, 10075

United States

University of North Carolina, School of Medicine

Chapel Hill, North Carolina, 27599

United States

Duke

Durham, North Carolina, 27705

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Ohio State University

Columbus, Ohio, 43210

United States

Kaiser Permanente

Portland, Oregon, 97227

United States

Temple University Hospital

Philadelphia, Pennsylvania, 19140

United States

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213

United States

Baylor Scott & White (BSW) Health-North

Dallas, Texas, 75246

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

University of Vermont

Burlington, Vermont, 05401

United States

Providence Health and Services

Spokane, Washington, 99204

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-11

Study Completion Date2026-05-01

Study Record Updates

Study Start Date2020-02-11

Study Completion Date2026-05-01

Terms related to this study

Keywords Provided by Researchers

Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
COPD
Roflumilast
Daliresp
Azithromycin

Additional Relevant MeSH Terms

Chronic Obstructive Pulmonary Disease Severe
Chronic Bronchitis