title: Clarithromycin therapy for patients with cystic fibrosis: a randomized controlled trial.
abstract: The clinically significant actions of oral azithromycin in modifying progressive cystic fibrosis (CF) lung disease have been well documented. In vitro and clinical data suggests that clarithromycin has immunomodulatory properties similar to other 14-member macrolides, however two previously reported short term, open label trials of clairthromycin in small numbers of patients with CF failed to show significant benefits in modifying lung function or inflammation. We performed an international double blind, cross-over trial in which 63 subjects with CF were studied while receiving either placeo or 500 mg oral clarithromycin twice daily for 5 months, with a 1-month wash-out. The primary efficacy end point was the change in lung function (FEV(1) and FVC) during the clarithromycin treatment period compared to placebo treatment. Secondary efficacy end points included; quality of life, number of pulmonary exacerbations, height and weight, sputum inflammatory mediator content, sputum transportability and surface properties, bacterial flora, nasal potential difference, and breath condensate. No significant difference in either the primary efficacy end point or any secondary end point was seen during the period of clarithromycin treatment compared to those seen during placebo administration. We conclude that clarithromycin is not effective in treating CF lung disease.
authors.affiliation: Department of Respiratory Medicine, Royal Children's Hospital, Murdoch Children's Research Instutite, Australia. phil.robinson@rch.org.au
authors.forename: P
authors.initials: P
authors.lastname: Robinson
authors.forename: Michael S
authors.initials: MS
authors.lastname: Schechter
authors.forename: Peter D
authors.initials: PD
authors.lastname: Sly
authors.forename: Kaye
authors.initials: K
authors.lastname: Winfield
authors.forename: Julie
authors.initials: J
authors.lastname: Smith
authors.forename: Siobhain
authors.initials: S
authors.lastname: Brennan
authors.forename: Masaharu
authors.initials: M
authors.lastname: Shinkai
authors.forename: Markus O
authors.initials: MO
authors.lastname: Henke
authors.forename: Bruce K
authors.initials: BK
authors.lastname: Rubin
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D017291:Clarithromycin / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003550:Cystic Fibrosis / Q000188:drug therapy*; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D056747:Immunomodulation; D008297:Male; D011500:Protein Synthesis Inhibitors / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects
chemical_list: D011500:Protein Synthesis Inhibitors; D017291:Clarithromycin