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Which drug keeps COPD patients out of the hospital?

NCT ID NCT04069312

Prevention Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study tested two medications, roflumilast and azithromycin, in over 1,000 people with severe COPD and chronic bronchitis. The goal was to see which drug better prevents hospitalizations or death. Participants were current or former smokers aged 40 or older who had been hospitalized for a COPD flare-up in the past year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,032 people

The number who actually took part.

Started

Feb 2020

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient and treating clinician considering treatment intensification with roflumilast or azithromycin to reduce the risk of COPD exacerbations 2. Age ≥ 40 years 3. Current or past smoker of at least 10 pack-years 4. Diagnosis by treating clinician of severe COPD and associated chronic bronchitis 5. Hospitalized with a diagnosis of COPD exacerbation or respiratory complications due to Coronavirus Disease 2019 (COVID 19) in the past 12 months 6. 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) 7. English or Spanish speaking 8. Willing and able to provide a contact telephone number Exclusion Criteria: 1. Unable or declines to provide informed consent 2. Declines to provide social security number, health insurance claims number or Tax Payer ID (as applicable) 3. History of intolerance to azithromycin or roflumilast that the patient or patient's treating clinician considers sufficiently serious to avoid either treatment option 4. 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.) 5. Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic 6. History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin 7. Moderate to severe liver impairment (Child-Pugh B or C) 8. Current pregnancy 9. Any other clinician-determined exclusion as per the clinician's clinical practice 10. 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.

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Conditions

The condition(s) this trial relates to.

chronic bronchitis chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic bronchitis Chronic obstructive pulmonary disease severe

Contacts and locations

Locations

  • Baylor Scott & White (BSW) Health-North

    Dallas, Texas, 75246, United States

  • Baystate Health

    Springfield, Massachusetts, 01199, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke

    Durham, North Carolina, 27705, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21224, United States

  • Kaiser Permanente

    Portland, Oregon, 97227, United States

  • Lenox Hill/Northern Westchester Hospital (Northwell Health)

    Mount Kisco, New York, 10549, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • NorthShore Hospital

    Glenview, Illinois, 60026, United States

  • Northwestern

    Chicago, Illinois, 60611, United States

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Providence Health and Services

    Spokane, Washington, 99204, United States

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama

    Birmingham, Alabama, 35233, United States

  • University of Arizona

    Tucson, Arizona, 85734, United States

  • University of California, Davis Health

    Sacramento, California, 95817, United States

  • University of Illinois Chicago

    Chicago, Illinois, 60612, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kansas

    Kansas City, Kansas, 66160, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Missouri, Kansas City

    Kansas City, Missouri, 64108, United States

  • University of North Carolina, School of Medicine

    Chapel Hill, North Carolina, 27599, United States

  • University of Pittsburg Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Vermont

    Burlington, Vermont, 05401, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.