Which drug cuts COPD Flare-Ups better? a Head-to-Head test
NCT ID NCT07795086
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial tests two oral drugs, roflumilast and azithromycin, as add-on treatments for people with severe COPD and a chronic bronchitis pattern. About 70 adults will take one of the drugs daily for six months while continuing their usual inhaled therapy. The goal is to see which drug reduces the number of moderate or severe flare-ups and hospitalizations, and which one improves breathing and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Roflumilast oral tablet and azithromycin oral tablet
- What this could lead to
- If one drug proves better, it could guide doctors in choosing an add-on therapy to reduce COPD flare-ups and hospital stays.
- What could go wrong
- This is a small, six-month trial, so results may not apply broadly. Both drugs have side effects, and the difference in effectiveness may be small.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2027
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Adults aged ≥40 years. * Confirmed diagnosis of COPD according to GOLD criteria. * Post-bronchodilator FEV₁/FVC \<0.70 on spirometry. * Severe airflow limitation (FEV₁ \<50% predicted). * History of frequent exacerbations, defined as ≥2 moderate exacerbations or ≥1 severe exacerbation requiring hospitalisation during the previous 12 months. * Receiving optimised inhaled therapy with LABA + LAMA, with or without ICS, according to clinical indication. * Clinically stable at the time of enrolment, with no acute COPD exacerbation. * Able to provide written informed consent and comply with study visits and treatment. Exclusion Criteria: * Diagnosis of bronchial asthma or other significant chronic respiratory disease. * Active respiratory infection, pneumonia, tuberculosis, or current acute COPD exacerbation. * Significant uncontrolled cardiovascular disease or clinically important cardiac arrhythmia. * Severe hepatic impairment or significant liver disease. * Known allergy or contraindication to roflumilast or azithromycin/macrolides. * History of significant QT prolongation or use of medicines with a major risk of QT prolongation. * Current or recent long-term treatment with roflumilast or prophylactic azithromycin/macrolide therapy. * Patients requiring systemic corticosteroids or antibiotics for an acute exacerbation at the time of enrolment. * Pregnant or breastfeeding women. * Patients with conditions likely to interfere with study treatment, follow-up, or outcome assessment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.