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Macrolide Antibiotic

Roflumilast vs Azithromycin for COPD Exacerbations (RELIANCE Trial)

Phase 3
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months and every 6 months up to 72 months
Awards & highlights

RELIANCE Trial 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.Check my eligibility
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.See study design
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.

RELIANCE Trial 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.

RELIANCE Trial 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

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

RELIANCE 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?

Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,996,258 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,264 Previous Clinical Trials
14,821,977 Total Patients Enrolled
4 Trials studying Chronic Bronchitis
3,149 Patients Enrolled for Chronic Bronchitis
Jerry Krishnan, MD, PhDPrincipal InvestigatorUniversity of Illinois, Chicago
1 Previous Clinical Trials

Media Library

Azithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04069312 — Phase 3
Chronic Bronchitis Research Study Groups: Roflumilast arm, Azithromycin arm
Chronic Bronchitis Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT04069312 — Phase 3
Azithromycin (Macrolide Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04069312 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What infections does Azithromycin arm usually help to clear up?

"Azithromycin is commonly used to treat genital ulcer disease (GUD), but it can also help with other infections like chlamydia, cervicitis, and in adult patients."

Answered by AI

What goals does this trial hope to achieve?

"The main goal of this 36-month long clinical trial is to study the number of hospitalizations not caused by the trial medication. Other objectives, or secondary outcomes, of this study include the number of adverse events, changes in sleep quality as assessed by the PROMIS scale (with 1 being the worst and 5 being the best), and the number of participants who stop taking the medication."

Answered by AI

Are there any open slots for volunteers in this experiment?

"Yes, the information on clinicaltrials.gov suggests that this study is presently looking for candidates. The study was originally posted on 2/11/2020 and was last updated on 3/25/2022. The clinical trial is recruiting for 3200 patients between 30 sites."

Answered by AI

Are there any known risks associated with taking Azithromycin?

"Azithromycin arm is safe according to our internal scale because it has reached Phase 3, which demonstrates both efficacy and safety through multiple rounds of testing."

Answered by AI

What other studies have been done that include Azithromycin in the treatment?

"63 clinical trials researching the efficacy of Azithromycin are currently underway. Of these, 18 are in Phase 3. Most of the studies are based in Quilmes, Buenos Aires, but there are 767 total locations running trials."

Answered by AI

Out of how many potential subjects has this research team recruited?

"Yes, the trial is still recruiting patients. According to the most recent update on clinicaltrials.gov, this study was last edited on March 25th, 2022 and is looking for 3200 individuals from 30 different enrolment locations."

Answered by AI

In how many different countries is this trial taking place?

"Currently, this trial has 30 patients that have been recruited, which includes locations such as Washington University School of Medicine in Saint Louis, University of Iowa in Iowa City and University of Pittsburg Medical Center in Pittsburgh. In addition to these locations, there are 27 other recruiting sites."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Arizona
Ohio
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of Arizona
University of Illinois, Chicago
Mount Sinai
Other
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

I want to breath better.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is this a paid trail?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)
2020. "Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04069312.
All > Vermont > Copd
~477 spots leftby Feb 2027
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