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Prophylactic Azithromycin for Bronchiectasis, a randomised controlled trial to assess whether azithromycin reduces exacerbation frequency, improves health-related quality of life and increases lung function.

Prophylactic Azithromycin for Bronchiectasis, a randomised controlled trial to assess whether azithromycin reduces exacerbation frequency, improves health-related quality of life and increases lung function.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000641493
Acronym
EMBRACE
Enrollment
141
Registered
2007-12-17
Start date
2008-01-24
Completion date
2009-10-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Bronchiectasis is a neglected health problem in New Zealand, particularly amongst Maori and Pacific peoples. It is a debilitating disease characterised by repeated respiratory infections. Azithromycin is a unique antibiotic with anti-inflammatory properties that has been shown to be effective as prophylaxis in cystic fibrosis. The aim of this study is to assess the effect of long term azithromycin in adult patients with non-cystic fibrosis bronchiectasis. It will be the first randomised, controlled trial in this important patient group and will provide data on clinically relevant outcome measures. The benefits to patients are expected to include improved quality of life, prevention or delay in decline of lung function and reduced acute healthcare utilisation and costs. Importantly, these benefits will also have a substantial impact on the health of Maori and Pacific peoples. We have a rare and unparalleled opportunity to undertake this study because of the high prevalence of bronchiectasis in NZ.

Interventions

One capsule of Azithromycin 500mg or placebo taken on Monday, Wednesday and Friday morning for 26 weeks.

Sponsors

Centre for Clinical Research and Effective Practice (CCRep)
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Participants must have a diagnosis of bronchiectasis based on a high resolution Computer Tomography (CT) scan 2. Patient must be clinically stable during the baseline period 3. Patient must have at least one exacerbation in the last 12 months requiring treatment with antibiotics.

Exclusion criteria

1. Patient with significant diseases other than bronchiectasis 2. Patient with cystic fibrosis 3. Patient with hypogammaglobulinaemia 4. Patients with primary dyskinesia 5. Patients with allergic brochopulmonary aspergillosis 6. Patients with non-tuberculous mycobacterial infection within 2 years. 7. Patients with a malignancyrequiring treatment in the last 5 years (patients with basal cell carcinoma are allowed) 8. Patients with active tuberculosis.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 25, 2026