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Title: | Azithromycin for prevention of exacerbations in non-cystic fi brosis bronchiectasis (EMBRACE): A randomised, double-blind, placebo-controlled trial. | Authors: | Storey L.;Ashton T.;Wong C.;Jayaram L.;Karalus N.;Eaton T.;Tong C.;Hockey H.;Milne D.;Fergusson W.;Tuffery C.;Sexton P. | Institution: | (Wong) Department of Respiratory Medicine, Middlemore Hospital, Counties Manukau District Health Board, Otahuhu, Auckland 2025, New Zealand (Tong, Storey) Centre for Clinical Research and Eff Ective Practice, New Zealand (Jayaram) Department of Microbiology, Auckland, New Zealand (Jayaram) Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand (Karalus) Department of Respiratory Medicine, Monash Medical Centre, Clayton, VIC, Australia (Tuffery) Department of Respiratory Medicine, Waikato Hospital, Waikato District Health Board, Hamilton, New Zealand (Eaton) 85 Totara Road, Whenuapai, Auckland, New Zealand (Hockey) Biometrics Matters Ltd, Hamilton, New Zealand (Milne) Department of Radiology, New Zealand (Fergusson, Sexton) Department of Respiratory Medicine, New Zealand (Ashton) Auckland City Hospital, Auckland District Health Board, Auckland, New Zealand (Ashton) 2School of Population Health, University of Auckland, Auckland, New Zealand | Issue Date: | 28-Aug-2012 | Copyright year: | 2012 | Publisher: | Elsevier B.V. Elsevier Limited (32 Jamestown Road, London NW1 7BY, United Kingdom) |
Place of publication: | United Kingdom | Publication information: | The Lancet. 380 (9842) (pp 660-667), 2012. Date of Publication: Augustus 2012. | Journal: | The Lancet | Abstract: | Background Azithromycin is a macrolide antibiotic with anti-infl ammatory 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 fi brosis 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 defi ned by highresolution 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 stratifi ed by centre. Participants, research assistants, and investigators were masked to treatment allocation. The coprimary endpoints were rate of eventbased exacerbations in the 6-month treatment period, change in forced expiratory volume in 1 s (FEV1) 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 059 per patient in the azithromycin group and 157 per patient in the placebo group in the 6-month treatment period (rate ratio 038, 95% CI 026-054; p<00001). Prebronchodilator FEV1 did not change from baseline in the azithromycin group and decreased by 004 L in the placebo group, but the diff erence was not signifi cant (004 L, 95% CI -003 to 012; p=0251). Additionally, change in SGRQ total score did not diff er between the azithromycin (-517 units) and placebo groups (-192 units; diff erence -325, 95% CI -721 to 072; p=0108). Interpretation Azithromycin is a new option for prevention of exacerbations in patients with non-cystic fi brosis 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. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1016/S0140-6736%2812%2960953-2 | PubMed URL: | 22901887 [http://www.ncbi.nlm.nih.gov/pubmed/?term=22901887] | ISSN: | 0140-6736 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/27320 | Type: | Article | Subjects: | male multicenter study nausea/si [Side Effect] New Zealand outcome assessment patient compliance priority journal quality of life questionnaire randomized controlled trial scoring system spirometry treatment duration treatment outcome treatment response vomiting/si [Side Effect] *azithromycin/ae [Adverse Drug Reaction] *azithromycin/ct [Clinical Trial] *azithromycin/cm [Drug Comparison] *azithromycin/dt [Drug Therapy] beta 2 adrenergic receptor stimulating agent/dt [Drug Therapy] cholinergic receptor blocking agent/dt [Drug Therapy] corticosteroid/cb [Drug Combination] corticosteroid/dt [Drug Therapy] corticosteroid/ih [Inhalational Drug Administration] corticosteroid/po [Oral Drug Administration] leukotriene receptor blocking agent/dt [Drug Therapy] mucolytic agent/dt [Drug Therapy] placebo unclassified drug *non cystic fibrosis bronchiectasis/di [Diagnosis] *non cystic fibrosis bronchiectasis/dt [Drug Therapy] *non cystic fibrosis bronchiectasis/ep [Epidemiology] St. George Respiratory Questionnaire long acting beta 2 adrenergic receptor stimulating agent/cb [Drug Combination] long acting beta 2 adrenergic receptor stimulating agent/dt [Drug Therapy] long acting beta 2 adrenergic receptor stimulating agent/ih [Inhalational Drug Administration] short acting beta 2 adrenergic receptor stimulating agent/dt [Drug Therapy] drug efficacy adult aged antibiotic therapy article *bronchiectasis/di [Diagnosis] *bronchiectasis/dt [Drug Therapy] *bronchiectasis/pc [Prevention] bronchodilatation constipation/si [Side Effect] controlled study corticosteroid therapy diarrhea/si [Side Effect] disease duration disease exacerbation double blind procedure drug safety drug withdrawal epigastric discomfort/si [Side Effect] female forced expiratory volume gastrointestinal symptom/si [Side Effect] high resolution computer tomography human lung function major clinical study bronchiectasis/dt [Drug Therapy] non cystic fibrosis bronchiectasis/dt [Drug Therapy] epigastric discomfort / side effect female forced expiratory volume gastrointestinal symptom / side effect high resolution computer tomography human lung function major clinical study male multicenter study nausea / side effect New Zealand outcome assessment patient compliance priority journal quality of life questionnaire randomized controlled trial scoring system controlled study treatment duration treatment outcome treatment response vomiting / side effect *bronchiectasis / *diagnosis / *drug therapy / *prevention article antibiotic therapy aged adult spirometry corticosteroid therapy diarrhea / side effect disease duration disease exacerbation double blind procedure drug efficacy drug safety drug withdrawal bronchiectasis / drug therapy non cystic fibrosis bronchiectasis / drug therapy bronchodilatation constipation / side effect |
Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Articles |
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