Azithromycin added to usual care to see if it lowers bronchiectasis flare-ups

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

AMBER is a randomized, double-blind, placebo-controlled study in adults with non-cystic fibrosis bronchiectasis. Participants receive either azithromycin 250 mg once daily or a matching placebo for 12 months, in addition to standard bronchiectasis care. The main goal is to see if azithromycin lowers the occurrence of at least one exacerbation during the 12-month follow-up. The trial uses an intention-to-treat analysis to compare groups. It is conducted within the Assiut University bronchiectasis translational research platform as part of the BASE framework.

Why it matters

Who can join: the full rules

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.

Where it's running

• Assiut university-Faculty of Medicine
  Asyut, Egypt Recruiting

Study contacts

• Principal investigator: Ahmad M. Shaddad, MD — Assiut University
• Study coordinator: Ahmad M Shaddad, MD
• Email: shaddad_ahmad@aun.edu.eg
• Phone: +201111171930

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bronchiectasis Phenotype Identification Model for Adults

  This study tests a baseline classifier to categorize adults with non-cystic fibrosis bronchiectasis into phenotype groups using data collected over time.

  Recruiting Assiut University · Asyut, Assiut Egypt · NCT07599969

• BASE: Aiming to test a simple, objective way to gauge bronchiectasis severity and predict flare-ups

  This study tests a new BASE framework to classify how severe non-cystic fibrosis bronchiectasis is right now and see if it can predict 12 months of worsening or flare-ups.

  Recruiting Assiut University · Asyut, Asyut Egypt · NCT07599839

• Investigating how cold viruses affect bronchiectasis exacerbations

  This study is trying to see if cold viruses make symptoms worse for people with bronchiectasis compared to healthy individuals.

  Recruiting Imperial College London · London · NCT06931002

• How viral infections affect people with chronic lung disease

  This study will test if respiratory viruses trigger flare-ups and change immune responses in adults with COPD or bronchiectasis.

  Recruiting Imperial College London · London · NCT06625944

• Using hypertonic saline to improve mucus clearance in bronchiectasis

  This study is testing if a special salt solution delivered through a nebulizer can help adults with bronchiectasis clear mucus from their lungs better.

  Recruiting Phase 4 University of North Carolina, Chapel Hill · Chapel Hill, North Carolina · NCT06242795

• Comparing Itraconazole with Standard Care for Chronic Aspergillus Infection in Bronchiectasis

  This study is testing if adding the antifungal medication itraconazole to standard care can help adults with bronchiectasis and chronic Aspergillus infection have fewer flare-ups.

  Recruiting Phase 3 Post Graduate Institute of Medical Education and Research, Chandigarh · Chandigarh, Chandigarh · NCT06160713

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.