HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS REGISTER		Author Keyword(s) Vol Page [Advanced]

This Article Full Text Full Text (PDF) All Versions of this Article: thx.2005.057950v1 61/10/895    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this link to a friend Similar articles in this journal Similar articles in PubMed Add article to my folders Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Clement, A Articles by Jais, J-P Search for Related Content PubMed PubMed Citation Articles by Clement, A Articles by Jais, J-P Topic Collections Relevant Article

Long term effects of azithromycin in patients with cystic fibrosis: a double blind, placebo controlled trial

¹ AP-HP, Hôpital Trousseau, Pediatric Pulmonary Department, Paris; Inserm, U719, Paris; and Université Pierre et Marie Curie-Paris 6, Paris, France
² Cystic Fibrosis Association Vaincre la Mucoviscidose, Paris, France
³ AP-HP, Hôpital Necker, Biostatistic Department, Paris; and Université René Descartes-Paris 5, Paris, France

Correspondence to:
Correspondence to:
Dr B Fauroux
AP-HP, Hôpital Trousseau, Pediatric Pulmonary Department, Inserm, U719, Université Pierre et Marie Curie-Paris 6, 26 Avenue du Docteur Arnold Netter, 75571 Paris cedex 12, France; brigitte.fauroux{at}trs.aphp.fr

Background: Macrolides display immunomodulatory effects that may be beneficial in chronic inflammatory pulmonary diseases. The aim of the study was to document whether long term use of azithromycin may be associated with respiratory benefits in young patients with cystic fibrosis.

Methods: A multicentre, randomised, double blind, placebo controlled trial was conducted from October 2001 to June 2003. The criteria for enrolment were age older than 6 years and forced expiratory volume in 1 second (FEV₁) of 40% or more. The active group received either 250 mg or 500 mg (body weight < or 40 kg) of oral azithromycin three times a week for 12 months. The primary end point was change in FEV₁.

Results: Eighty two patients of mean (SD) age 11.0 (3.3) years and mean (SD) FEV₁ 85 (22)% predicted were randomised: 40 in the azithromycin group and 42 in the placebo group. Nineteen patients were infected with Pseudomonas aeruginosa. The relative change in FEV₁ at month 12 did not differ significantly between the two groups. The number of pulmonary exacerbations (count ratio 0.50 (95% CI 0.32 to 0.79), p<0.005), the time elapsed before the first pulmonary exacerbation (hazard ratio 0.37 (95% CI 0.22 to 0.63), p<0.0001), and the number of additional courses of oral antibiotics were significantly reduced in the azithromycin group regardless of the infectious status (count ratio 0.55 (95% CI 0.36 to 0.85), p<0.01). No severe adverse events were reported.

Conclusion: Long term use of low dose azithromycin in young patients with cystic fibrosis has a beneficial effect on lung disease expression, even before infection with Pseudomonas aeruginosa.

Abbreviations: CF, cystic fibrosis; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity

Keywords: children; cystic fibrosis; azithromycin; lung function; respiratory exacerbation

Relevant Article

Airwaves

Wisia Wedzicha
Thorax 2006 61: 831. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

				C. B Kirk IS THE FREQUENCY OF RECURRENT CHEST INFECTIONS, IN CHILDREN WITH CHRONIC NEUROLOGICAL PROBLEMS, REDUCED BY PROPHYLACTIC AZITHROMYCIN? Arch. Dis. Child., May 1, 2008; 93(5): 442 - 444. [Full Text] [PDF]

				L. B. Ware Clinical Year in Review III: Asthma, Lung Transplantation, Cystic Fibrosis, Acute Respiratory Distress Syndrome Proceedings of the ATS, September 15, 2007; 4(6): 489 - 493. [Full Text] [PDF]

				J. McCormack, S. Bell, S. Senini, K. Walmsley, K. Patel, C. Wainwright, D. Serisier, M. Harris, and S. Bowler Daily versus weekly azithromycin in cystic fibrosis patients Eur. Respir. J., September 1, 2007; 30(3): 487 - 495. [Abstract] [Full Text] [PDF]

				N. Mayer-Hamblett, B. W. Ramsey, and R. A. Kronmal Advancing Outcome Measures for the New Era of Drug Development in Cystic Fibrosis Proceedings of the ATS, August 1, 2007; 4(4): 370 - 377. [Abstract] [Full Text] [PDF]

				C. H. Goss and A. L. Quittner Patient-reported Outcomes in Cystic Fibrosis Proceedings of the ATS, August 1, 2007; 4(4): 378 - 386. [Abstract] [Full Text] [PDF]

				S. C Bell and P. J Robinson Exacerbations in cystic fibrosis: 2 {middle dot} Prevention Thorax, August 1, 2007; 62(8): 723 - 732. [Abstract] [Full Text] [PDF]

				F. J. Accurso Update in Cystic Fibrosis 2006 Am. J. Respir. Crit. Care Med., April 15, 2007; 175(8): 754 - 757. [Full Text] [PDF]

				B. Enderby and I. Doull Hypertonic saline inhalation in cystic fibrosis--salt in the wound, or sweet success? Arch. Dis. Child., March 1, 2007; 92(3): 195 - 196. [Full Text] [PDF]