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Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

NCT04069312 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1032

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

  • Chronic Obstructive Pulmonary Disease Severe
  • Chronic Bronchitis

Interventions

DRUG

Roflumilast

Prescription for Roflumilast (250 mcg/day x 4 weeks, then 500 mcg/day or alternate regimen) x 6 to 72 months

DRUG

Azithromycin

Prescription for Azithromycin (250 mg/day, or 500 mg three times per week, or alternate regimen) x 6 to 72 months

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • University of Illinois at Chicago

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Jerry Krishnan, MD, PhD · University of Illinois Chicago

  • Robert Wise, MD · Johns Hopkins School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-11
Primary Completion
2026-03-01
Completion
2026-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04069312 on ClinicalTrials.gov