Tests azithromycin in adults with non-cystic fibrosis bronchiectasis
Tests whether azithromycin added to usual care reduces flare-ups in adults with bronchiectasis.
Plain-language title generated from the registry record
Registry title: Azithromycin to Modify Bronchiectasis Exacerbation Risk
Key facts
- Where
- Asyut, EgyptSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with bronchiectasis that is not caused by cystic fibrosis. It tests azithromycin or a placebo, taken daily for 12 months, on top of usual care.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Bronchiectasis not caused by cystic fibrosis, confirmed by clinical assessment and a high-resolution CT scan.
- Earlier treatment
- People who need long-term maintenance macrolide treatment at enrolment, or who cannot safely stop it before enrolment, cannot join.
Main reasons for not taking part
- Cystic fibrosis-related bronchiectasis
- Active lung tuberculosis, or active nontuberculous mycobacterial lung disease needing treatment
- Known allergy, contraindication or serious intolerance to azithromycin or macrolide drugs
- Heart findings that make long-term azithromycin unsafe
- Unable or unwilling to complete the 12-month follow-up
Read by machine on 12 November 2026.
Where in Egypt
- Assiut University- Faculty of MedicineAsyut, EgyptContact: Ahmad M Shaddad, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Assiut University
- Trial code
- NCT07608328
- Record updated
- 24 September 2026
- Original description
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).Read full original descriptionShow less
AMBER: Azithromycin to Modify Bronchiectasis Exacerbation Risk - A Double-Blind Placebo-Controlled Randomized Trial in Adults With Non-Cystic Fibrosis Bronchiectasis
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.
Inclusion: 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.
Exclusion: Recent major thoracic surgery or acute thoracic trauma interfering with baseline respiratory assessment; Requirement for long-term maintenance macrolide therapy at enrollment; 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; 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.