Status:
ACTIVE_NOT_RECRUITING
Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
University of Illinois at Chicago
Conditions:
Chronic Obstructive Pulmonary Disease Severe
Chronic Bronchitis
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
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 ver...
Detailed Description
RELIANCE is a U.S.-based pragmatic clinical trial funded by the Patient-Centered Outcomes Research Institute (PCORI) to compare long-term use of roflumilast vs. azithromycin in up to 1,250 patients. I...
Eligibility Criteria
Inclusion
- Patient and treating clinician considering treatment intensification with roflumilast or azithromycin to reduce the risk of COPD exacerbations
- Age ≥ 40 years
- Current or past smoker of at least 10 pack-years
- Diagnosis by treating physician of severe COPD and associated chronic bronchitis
- Hospitalized with a diagnosis of COPD exacerbation or respiratory complications due to COVID 19 in the past 12 months
- Current medications include inhaled Long Acting Muscarinic Antagonist (LAMA), Long Acting Beta Agonist (LABA) /LAMA, or Inhaled Corticosteroids (ICS) /LABA(note patients prescribed or using SABA, SAMA, or SABA/SAMA on a scheduled basis (e.g., every 6 hours) are eligible since the patient is receiving functional controller therapy);
- English or Spanish speaking
- Willing and able to provide a contact telephone number.
Exclusion
- Unable or declines to provide informed consent;
- Declines to provide social security number, health insurance claims number or Tax Payer ID (as applicable)
- History of intolerance to azithromycin or roflumilast that the patient or patient's treating clinician considers sufficiently serious to avoid either treatment option;
- Current treatment with long-term (more than 30 days) roflumilast, azithromycin or ensifentrine (previous treatment with 1 or more doses of azithromycin, roflumilast or ensifentrine is not an exclusion criterion, as long as the patient and clinician are seeking treatment intensification options and would be willing to use azithromycin or roflumilast, as per randomized treatment assignment.)
- Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic;
- History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
- Moderate to severe liver impairment (Child-Pugh B or C)
- Current pregnancy
- Any other clinician-determined exclusion as per the clinician's clinical practice
- The clinicians will be provided the FDA-approved prescribing information for roflumilast and azithromycin. The prescribing information includes a list of warnings and precautions that identifies the potential for adverse effects and is intended to support clinical decision-making that takes into account the risks and benefits of roflumilast and azithromycin for each patient
Key Trial Info
Start Date :
February 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
1032 Patients enrolled
Trial Details
Trial ID
NCT04069312
Start Date
February 11 2020
End Date
March 1 2026
Last Update
December 16 2025
Active Locations (29)
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1
University of Alabama
Birmingham, Alabama, United States, 35233
2
University of Arizona
Tucson, Arizona, United States, 85734
3
University of California, Davis Health
Sacramento, California, United States, 95817
4
Northwestern
Chicago, Illinois, United States, 60611