Azithromycin to Modify Bronchiectasis Exacerbation Risk

Summary

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.

Conditions

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

Interventions

OTHER

Standard Bronchiectasis Care

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.

DRUG

Azithromycin

Azithromycin 250 milligrams orally once daily for 12 months, added to standard bronchiectasis care.

DRUG

Matching Placebo

Matching inert placebo tablet orally once daily for 12 months, added to standard bronchiectasis care. The placebo will not contain active azithromycin.

Sponsors & Collaborators

• Assiut University

  lead OTHER

Principal Investigators

• Ahmad M. Shaddad, MD · Assiut University

• Aliae M. Hussien, MD · Assiut University

• Maiada K. Hashem, MD · Assiut University

• Alaa S. Ali · Assiut University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-21

Primary Completion

2027-06-21

Completion

2027-06-30

Countries

• Egypt

Study Locations