๐ฌIn plain words
What the trial is, and whether it could suit you
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 As
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* 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 Criteria:
* Cystic fibrosis-related bronchiectasis.
* 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.
* Recent major thoracic surgery or acute thoracic trauma interfering with baseline respiratory assessment.
* Known hypersensitivity, contraindication, or serious intolerance to azithromycin or macrolide therapy.
* Baseline cardiac findings judged by the investigator to make long-term azithromycin unsafe.
* Requirement for long-term maintenance macrolide therapy at enrollment.
* Current long-term maintenance macrolide use that cannot be safely discontinued before enrollment.
* Inability to complete required baseline disease-signature assessment.
* Inability or unwillingness to complete planned 12-month follow-up.
* Refusal to participate.
๐
What it tests
- Standard Bronchiectasis Care
- Azithromycin
- Matching Placebo
Assiut university-Faculty of Medicine
Asyut, Egypt
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.