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NCT07608328From ClinicalTrials.govRecruiting

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

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

At a glance

Phase
Phase 4
Study type
Interventional
Sponsor
Assiut University
Enrolment target
500
Started
29 June 2026
Main results due
21 June 2027
Study sites
1
Registry updated
24 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Assiut university-Faculty of Medicine

    Asyut, Egypt

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07608328. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Azithromycin to Modify Bronchiectasis Exacerbation Risk | Trialion