NCT07795086Not yet recruitingPhase 4
Comparative Effectiveness of Roflumilast and Azithromycin in Reducing Exacerbations in Severe Chronic Obstructive Pulmonary Disease ( COPD ) Patients With Chronic Bronchitis Phenotype
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
"The study is a randomized controlled trial comparing roflumilast and azithromycin as add-on therapies in 70 patients with severe chronic obstructive pulmonary disease (COPD ) and frequent exacerbations. Participants will receive one of the two treatments for six months while continuing standard inhaled therapy. The study aims to determine which drug is more effective in reducing exacerbations and improving clinical outcomes such as forced expiratory volume in one second( FEV1) and modified medical research council ( mMRC)dyspnea scale , hospitalization, adherence, and safety, thereby providing evidence to guide chronic obstructive pulmonary disease management in our local population."
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 10 Aug 2026
- Start date
- 1 Feb 2027
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Sidra Aziz
- Diseases
- COPD
- NCT number
- NCT07795086
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 70
- From 1 Feb 2027 to the primary completion date, 28 Feb 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- Patients with conditions likely to interfere with study treatment, follow-up, or outcome assessment.
Lab values
- History of significant QT prolongation or use of medicines with a major risk of QT prolongation.
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.