NCT07608328 Azithromycin to Modify Bronchiectasis Exacerbation Risk
| NCT ID | NCT07608328 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Assiut University |
| Condition | Non-cystic Fibrosis Bronchiectasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-06-29 |
| Primary Completion | 2027-06-21 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 500 participants in total. It began in 2026-06-29 with a primary completion date of 2027-06-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Ahmad M. Shaddad, MD
PRINCIPAL INVESTIGATOR
Assiut University
Frequently Asked Questions
Who can join the NCT07608328 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-cystic Fibrosis Bronchiectasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07608328 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07608328 currently recruiting?
Yes, NCT07608328 is actively recruiting participants. Contact the research team at shaddad_ahmad@aun.edu.eg for enrollment information.
Where is the NCT07608328 trial being conducted?
This trial is being conducted at Asyut, Egypt.
Who is sponsoring the NCT07608328 clinical trial?
NCT07608328 is sponsored by Assiut University. The principal investigator is Ahmad M. Shaddad, MD at Assiut University. The trial plans to enroll 500 participants.