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Macrolide Antibiotic

Roflumilast vs Azithromycin for COPD Exacerbations (RELIANCE Trial)

Phase 4
Recruiting
Led By Jerry Krishnan, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hospitalized with a diagnosis of COPD exacerbation or respiratory complications due to Covid 19 in the past 12 months
Age ≥ 40 years
Must not have
History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
Moderate to severe liver impairment (Child-Pugh B or C)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months and every 6 months up to 72 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing whether roflumilast is as effective as azithromycin in preventing COPD exacerbations that require hospitalization or death.

Who is the study for?
This trial is for adults over 40 who have severe COPD with chronic bronchitis, are current or past smokers with a history of at least 10 pack-years, and were hospitalized for COPD exacerbations or respiratory issues from Covid-19 in the last year. They must be on certain inhaled medications and considering additional treatments to prevent further COPD flare-ups.
What is being tested?
The RELIANCE study is testing whether roflumilast (Daliresp) can be as effective as azithromycin in preventing hospitalizations or death among high-risk COPD patients. Participants will randomly receive one of these drugs over a period of six years to compare their effectiveness.
What are the potential side effects?
Roflumilast may cause weight loss, diarrhea, nausea, headaches, back pain, flu-like symptoms, and mood changes. Azithromycin could lead to digestive upset, hearing changes like ringing ears, dizziness and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was hospitalized for COPD flare-up or COVID-19 breathing issues in the last year.
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I am 40 years old or older.
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I have smoked at least 10 pack-years.
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I have been diagnosed with severe COPD and chronic bronchitis.
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I am currently using inhaled medications for my lung condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I've had liver problems after taking azithromycin.
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My liver function is significantly impaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months and every 6 months up to 72 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months and every 6 months up to 72 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of All-cause deaths
Number of All-cause hospitalizations
Secondary study objectives
Anxiety
Change in depression as assessed by the PROMIS scale
Change in fatigue as assessed by the PROMIS scale
+9 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Roflumilast armActive Control1 Intervention
Participants will receive prescription for Roflumilast (250 mcg/day x 4 weeks, then 500 mcg/day or alternate regimen) x 6 to 72 months
Group II: Azithromycin armActive Control1 Intervention
Participants will receive prescription for Azithromycin (250 mg/day, or 500 mg three times per week, or alternate regimen) x 6 to 72 months

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoOTHER
639 Previous Clinical Trials
1,567,515 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
578 Previous Clinical Trials
27,079,869 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,335 Previous Clinical Trials
14,874,463 Total Patients Enrolled
Jerry Krishnan, MD, PhDPrincipal InvestigatorUniversity of Illinois Chicago
1 Previous Clinical Trials
Robert Wise, MDPrincipal InvestigatorJohns Hopkins School of Medicine
7 Previous Clinical Trials
6,448 Total Patients Enrolled

Media Library

Azithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04069312 — Phase 4
Chronic Obstructive Pulmonary Disease Research Study Groups: Roflumilast arm, Azithromycin arm
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT04069312 — Phase 4
Azithromycin (Macrolide Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04069312 — Phase 4
~243 spots leftby Mar 2026
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