Cited by 600Cystic Fibrosis Research AdvancesChronic Obstructive Pulmonary Disease (COPD) ResearchMycobacterium research and diagnosis

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Azithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis (EMBRACE): a randomised, double-blind, placebo-controlled trial

Wong, Conroy, Jayaram, Lata, Karalus, Noel, Eaton, Tam, Tong, Cecilia, Hockey, Hans, Milne, David, Fergusson, Wendy, Tuffery, Christine, Sexton, Paul, Storey, Louanne, Ashton, Toni·2012·The Lancet

DOI 10.1016/s0140-6736(12)60953-2

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Abstract

Background Azithromycin is a macrolide antibiotic with anti-inflammatory and immunomodulatory properties. We tested the hypothesis that azithromycin would decrease the frequency of exacerbations, increase lung function, and improve health-related quality of life in patients with non-cystic fibrosis bronchiectasis.Methods We undertook a randomised, double-blind, placebo-controlled trial at three centres in New Zealand. Between Feb 12, 2008, and Oct 15, 2009, we enrolled patients who were 18 years or older, had had at least one pulmonary exacerbation requiring antibiotic treatment in the past year, and had a diagnosis of bronchiectasis defined by high-resolution CT scan. We randomly assigned patients to receive 500 mg azithromycin or placebo three times a week for 6 months in a 1:1 ratio, with a permuted block size of six and sequential assignment stratified by centre. Participants, research assistants, and investigators were masked to treatment allocation. The coprimary endpoints were rate of event-based exacerbations in the 6-month treatment period, change in forced expiratory volume in 1 s (FEV(1)) before bronchodilation, and change in total score on St George's respiratory questionnaire (SGRQ). Analyses were by intention to treat. This study is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12607000641493.Findings 71 patients were in the azithromycin group and 70 in the placebo group. The rate of event-based exacerbations was 0·59 per patient in the azithromycin group and 1·57 per patient in the placebo group in the 6-month treatment period (rate ratio 0·38, 95% CI 0·26-0·54; p<0·0001). Prebronchodilator FEV(1) did not change from baseline in the azithromycin group and decreased by 0·04 L in the placebo group, but the difference was not significant (0·04 L, 95% CI -0·03 to 0·12; p=0·251). Additionally, change in SGRQ total score did not differ between the azithromycin (-5·17 units) and placebo groups (-1·92 units; difference -3·25, 95% CI -7·21 to 0·72; p=0·108).Interpretation Azithromycin is a new option for prevention of exacerbations in patients with non-cystic fibrosis bronchiectasis with a history of at least one exacerbation in the past year.Funding Health Research Council of New Zealand and Auckland District Health Board Charitable Trust.

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Authors: Wong, C., Jayaram, L., Karalus, N., Eaton, T., Tong, C., Hockey, H., Milne, D., Fergusson, W., Tuffery, C., Sexton, P., Storey, L., & Ashton, T.
Affiliations: Middlemore Hospital (NZ)
Monash Medical Centre (AU)
Waikato Hospital (NZ)
Auckland City Hospital (NZ)
University of Auckland (NZ)
Corresponding author: Wong, Conroy
ORCID: Wong, Conroy
Jayaram, Lata
Hockey, Hans
Milne, David
Sexton, Paul
Ashton, Toni
Venue: The Lancet
Publisher: Elsevier BV
Published: 2012-08
Volume: 380
Issue: 9842
Pages: 660-667
ISSN: 0099-5355 (ISSN-L)
0140-6736
DOI: 10.1016/s0140-6736(12)60953-2
OpenAlex: W2169216429
Cited by: 600
References: 38
Citations by year: 2026: 33 · 2025: 22 · 2024: 29 · 2023: 21 · 2022: 33 · 2021: 36 · 2020: 37 · 2019: 48 · 2018: 56 · 2017: 59 · 2016: 45 · 2015: 52 · 2014: 67 · 2013: 55 · 2012: 6
FWCI: 46.39
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: The Lancet (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Cystic Fibrosis Research Advances
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Chronic Obstructive Pulmonary Disease (COPD) Research
Health Sciences › Medicine › Epidemiology › Mycobacterium research and diagnosis
Keywords: azithromycin, non-cystic fibrosis bronchiectasis, pulmonary exacerbations, macrolide antibiotics, anti-inflammatory therapy, lung function, health-related quality of life, St George's Respiratory Questionnaire, FEV1, EMBRACE trial, antibiotic prophylaxis, immunomodulation, adverse events
MeSH terms: Adult, Aged, Anti-Bacterial Agents, Bronchiectasis, Cystic Fibrosis, Double-Blind Method, Drug Administration Schedule, Female, Forced Expiratory Volume, Humans, Male, Middle Aged, Quality of Life, Vital Capacity, Treatment Outcome, Azithromycin, Secondary Prevention

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Azithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis (EMBRACE): a randomised, double-blind, placebo-controlled trial

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