Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE) (NCT04069312) | Clinical Trial Compass
CompletedPhase 4
Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)
United States1,032 participantsStarted 2020-02-11
Plain-language 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 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.
Who can participate
Age range40 Years
SexALL
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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 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 Criteria:
* 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…