Roflumilast or Azithromycin to Prevent COPD Exacerbations Trial

Completed · Phase 3

Conditions studied: Chronic Obstructive Pulmonary Disease Severe, Chronic Bronchitis

In brief

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.

Key facts

Study ID

NCT04069312

Run by

Johns Hopkins University

People needed

1032

Starts

2020-02-11

Expected to finish

2026-03-01

Last updated by the study team

2026-07-08

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 clinician of severe COPD and associated chronic bronchitis
• Hospitalized with a diagnosis of COPD exacerbation or respiratory complications due to Coronavirus Disease 2019 (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 Short-Acting Beta-Agonist (SABA), Short-Acting Muscarinic Antagonist (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

You may not qualify if…

• 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.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• University of California, Davis Health — Sacramento, California, United States
• Northwestern — Chicago, Illinois, United States
• University of Illinois Chicago — Chicago, Illinois, United States
• NorthShore Hospital — Glenview, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas — Kansas City, Kansas, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Baystate Health — Springfield, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University of Missouri, Kansas City — Kansas City, Missouri, United States
• Lenox Hill/Northern Westchester Hospital (Northwell Health) — Mount Kisco, New York, United States
• Mount Sinai — New York, New York, United States
• University of North Carolina, School of Medicine — Chapel Hill, North Carolina, United States
• Duke — Durham, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Kaiser Permanente — Portland, Oregon, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• University of Pittsburg Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor Scott & White (BSW) Health-North — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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