NCT07608328RecruitingPhase 4
Azithromycin to Modify Bronchiectasis Exacerbation Risk
AMBER: Azithromycin to Modify Bronchiectasis Exacerbation Risk - A Double-Blind Placebo-Controlled Randomized Trial in Adults With Non-Cystic Fibrosis Bronchiectasis
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
The Azithromycin to Modify Bronchiectasis Exacerbation Risk (AMBER) trial is a prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial in adults with clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB). The trial evaluates whether azithromycin 250 mg orally once daily for 12 months, added to standard bronchiectasis care, reduces the occurrence of at least one bronchiectasis exacerbation during 12-month follow-up compared with matching placebo added to standard bronchiectasis care. Participants will be randomized in a 1:1 allocation ratio to standard care plus matching placebo or standard care plus azithromycin. The primary analysis will follow the intention-to-treat (ITT) principle. The AMBER trial is embedded within the Assiut University bronchiectasis translational research platform and is linked to the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework and the Bronchiectasis Phenotype Identification Model (BPIM). BASE and BPIM are not used for randomization stratification and will not modify the primary randomized comparison. The locked Version 1.0 methodological disclosure document, protocol, and statistical analysis plan (SAP), primary sample-size source code, and endpoint-level sample-size support matrix are archived in Zenodo: https://doi.org/10.5281/zenodo.20178963. The AMBER public preregistration is also available through the Open Science Framework (OSF) under Digital Object Identifier (DOI) 10.17605/OSF.IO/RE54V.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 15 May 2026
- Start date
- 29 Jun 2026
- Primary completion date
- 21 Jun 2027
- Lead sponsor
- Assiut University
- Diseases
- Cystic fibrosis
- NCT number
- NCT07608328
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 500
- From 29 Jun 2026 to the primary completion date, 21 Jun 2027
- 1 site in 1 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
- Recent major thoracic surgery or acute thoracic trauma interfering with baseline respiratory assessment.
- Requirement for long-term maintenance macrolide therapy at enrollment.
Other illness
- Traction bronchiectasis due to advanced fibrotic interstitial lung disease as the dominant respiratory diagnosis.
- Active pulmonary tuberculosis at enrollment.
- Active nontuberculous mycobacterial pulmonary disease requiring specific treatment at enrollment.
- Active malignancy or terminal non-respiratory illness expected to prevent planned follow-up.
- Acute life-threatening illness preventing safe enrollment, baseline assessment, or randomization.
- Known hypersensitivity, contraindication, or serious intolerance to azithromycin or macrolide therapy.
- Baseline cardiac findings judged by the investigator to make long-term azithromycin unsafe.
- Inability to complete required baseline disease-signature assessment.
Other
- Cystic fibrosis-related bronchiectasis.
- Current long-term maintenance macrolide use that cannot be safely discontinued before enrollment.
- Inability or unwillingness to complete planned 12-month follow-up.
- Refusal to participate.
Who the study is looking for
- Adult patients aged 18 years or older.
- Clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB).
- Diagnosis supported by clinical assessment and high-resolution computed tomography (HRCT).
- Patients attending outpatient clinics, inpatient wards, respiratory follow-up services, or routine bronchiectasis care pathways at Assiut University Hospitals during the enrollment period.
- Suitable for baseline disease-signature assessment.
- Able to undergo protocol-defined clinical, functional, radiological, oxygenation, inflammatory, symptom, and safety assessment.
- Able to complete planned 12-month follow-up.
- Eligible for randomization after baseline safety evaluation.
- Written informed consent obtained from the participant or legal representative.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assiut University- Faculty of Medicine Coordinator of this site? Confirm its status | Asyut | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.