RECRUITING Phase 4 ClinicalTrials.gov

Azithromycin to Modify Bronchiectasis Exacerbation Risk

Sponsor: Assiut University • ClinicalTrials.gov ID: NCT07608328

Registry updated: 2026-09-24

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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). 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.

Interventions

Standard Bronchiectasis Care (Other)
Standard bronchiectasis care provided in both randomized groups according to institutional practice and treating physician judgment. Standard bronchiectasis care may include mucolytics, bronchodilators, chest physiotherapy, patient education, airway-clearance support, and treatment of acute exacerbations with antibiotics with or without systemic corticosteroids according to clinical indication. Standard bronchiectasis care is provided as shared background care in both arms and is not the randomized treatment contrast. Clinically required rescue or emergency care remains permitted according to treating physician judgment.
Azithromycin (Drug)
Azithromycin 250 milligrams orally once daily for 12 months, added to standard bronchiectasis care.
Matching Placebo (Drug)
Matching inert placebo tablet orally once daily for 12 months, added to standard bronchiectasis care. The placebo will not contain active azithromycin.

Eligibility criteria

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.

Conditions

Non-cystic Fibrosis Bronchiectasis Bronchiectasis Adult Bronchiectasis Bronchiectasis With Acute Exacerbation

Locations

Assiut university-Faculty of Medicine — Asyut, Egypt

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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