RELIANCE - Roflumilast and Azithromycin to Prevent COPD Exacerbations

A multi-center, randomized, 36-month, parallel- group, non-inferiority, phase III study to compare the effectiveness of roflumilast (Daliresp, 500 mcg quaque die (QD) or alternate regimen) therapy versus azithromycin (250 mg QD, 500 mg QD three times per week, or alternate regimen) to prevent hospitalization or death in a patients at high risk for COPD exacerbations.

The trial is a parallel, pragmatic non-inferiority trial with two treatment groups, roflumilast and azithromycin. Up to 3,200 participants will be randomized (1:1) to receive a prescription for one of the two treatments. Treatment assignments will be stratified by site and smoking status (former versus current) using a permuted block design with multiple block sizes.

Eligibility Criteria

  • Age 40 years and older¬†
  • Patient and treating clinician considering treatment intensification with roflumilast or azithromycin to reduce the risk of COPD exacerbations
  • Current or past smoker of at least 10 pack-years
  • Diagnosis of severe COPD and associated chronic bronchitis
  • Hospitalized with a diagnosis of COPD exacerbation 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
  • English or Spanish speaking

Exclusion Criteria

  • Unable or declines to provide informed consent;
  • Declines to provide social security number or health insurance claims number (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 or azithromycin (previous treatment with 1 or more doses of azithromycin or roflumilast 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

 

Principal Investigator

Mario Castro, MD

Study Contact

Shelby Almo (913) 574-3006, salmo@kumc.edu

Estimated Completion Date

Wednesday, April 1, 2020

ClinicalTrials.gov #

NCT04069312
02/21/2020