Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

Conditions

• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease Severe

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Roflumilast — DRUG
  Prescription for Roflumilast (250 mcg/day x 4 weeks, then 500 mcg/day or alternate regimen) x 6 to 72 months
• Azithromycin — DRUG
  Prescription for Azithromycin (250 mg/day, or 500 mg three times per week, or alternate regimen) x 6 to 72 months

Study Details

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.

Key Dates

Start date

Feb 11, 2020

Status verified

May 2026

Primary completion

Mar 1, 2026

Completion

Mar 1, 2026

Study Design

Enrollment

1,032 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Roflumilast arm
  Participants will receive prescription for Roflumilast (250 mcg/day x 4 weeks, then 500 mcg/day or alternate regimen) x 6 to 72 months
• Active Comparator: Azithromycin arm
  Participants will receive prescription for Azithromycin (250 mg/day, or 500 mg three times per week, or alternate regimen) x 6 to 72 months

Primary Outcome Measure

Time to first all-cause hospitalization or all-cause death [ Time Frame: Up to 72 months ]

Locations (29)

Find similar trials in Birmingham, AL

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