Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

Launched by JOHNS HOPKINS UNIVERSITY · Aug 23, 2019

Keywords

ClinConnect Summary

The RELIANCE clinical trial is studying two medications, roflumilast (also known as Daliresp) and azithromycin, to see which one is better at preventing serious problems for people with severe Chronic Obstructive Pulmonary Disease (COPD) who are at high risk for worsening symptoms. This 6-year study will compare how effective each treatment is in helping patients avoid hospital visits or even death due to COPD flare-ups.

To be eligible for this trial, participants need to be at least 40 years old and have a history of smoking, along with a diagnosis of severe COPD and chronic bronchitis. They should also have been hospitalized for COPD-related issues in the past year. If you or someone you know fits this description and is considering treatment options to help manage COPD, this study may be a good opportunity. Participants will be randomly assigned to receive either roflumilast or azithromycin, and they'll be monitored over the course of the study to see how well each treatment works. It's important to note that potential participants should be comfortable speaking English or Spanish and must be able to understand the study details before joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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
• • 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