IRB Study Number 18-747
Status Recruiting
Phase Phase 3
Location Cleveland Clinic Main Campus
Institute Respiratory Institute
Description
The RELIANCE study is a national study designed to compare two medicines currently used by lung doctors, azithromycin and roflumilast (Daliresp®). The study aims to find out which medicine works to control COPD attacks better for different types of people. If you have COPD and have been in the hospital in the past 12 months, you may qualify. Check with your lung doctor to see if you are a good fit. If you have questions, contact [enter local coordinator contact].
Inclusion Criteria
Patient and treating clinician considering treatment intensification with roflumilast or azithromycin to reduce the risk of COPD exacerbations 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 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 Age ≥ 40 years
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
