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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months and every 6 months up to 72 months

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

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoOTHER

632 Previous Clinical Trials

1,566,465 Total Patients Enrolled

1 Trials studying Chronic Bronchitis

2,981 Patients Enrolled for Chronic Bronchitis

Patient-Centered Outcomes Research InstituteOTHER

568 Previous Clinical Trials

27,248,159 Total Patients Enrolled

Johns Hopkins UniversityLead Sponsor

2,307 Previous Clinical Trials

14,860,659 Total Patients Enrolled

4 Trials studying Chronic Bronchitis

3,149 Patients Enrolled for Chronic Bronchitis

Media Library

Azithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04069312 — Phase 4

Chronic Bronchitis Research Study Groups: Roflumilast arm, Azithromycin arm

Chronic Bronchitis 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

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