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 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.