title: Effects of six-week clarithromycin therapy in corticosteroid-dependent asthma: A randomized, double-blind, placebo-controlled pilot study.
abstract: BACKGROUND
  Although corticosteroids such as prednisone are efficacious for the treatment of severe asthma, chronic administration of oral corticosteroid therapy is associated with significant adverse effects. Previous studies have shown that clarithromycin is effective in reducing bronchial hyperresponsiveness and allergen-induced bronchoconstriction. However, the effect of long-term clarithromycin therapy in patients with prednisone-dependent asthma is uncertain.
  
  
  OBJECTIVE
  This study was conducted to determine the effects of oral clarithromycin on prednisone daily dosage, pulmonary function, quality of life (QOL), and asthmatic symptoms in patients with corticosteroid-dependent asthma.
  
  
  METHODS
  This 14-week, prospective, randomized, double-blind, placebo-controlled pilot study was conducted at Pulmonary Associates (Phoenix, Arizona) and the University of Illinois at Chicago Medical Center (Chicago, Illinois). Patients aged 18 to 75 years with an established diagnosis of asthma and who had been receiving ≥5 mg/d of prednisone for the preceding 6 months were enrolled. After a 4-week data-collection period, patients received clarithromycin 500 mg BID for 6 weeks, followed by a 4-week follow-up period. The effects of clarithromycin therapy on prednisone dosage requirements, pulmonary function (as assessed using spirometry), QOL, and asthmatic symptoms (nocturnal asthma, shortness of breath, chest discomfort, wheezing, and cough) were assessed.
  
  
  RESULTS
  Fourteen patients (9 men, 5 women; mean [SD] age, 62 [13] years) completed the study and were included in the final analysis. One patient withdrew from the study due to clarithromycin-related nausea. After 6 weeks of clarithromycin therapy, patients were able to tolerate a significant reduction in mean (SD) prednisone dosage from baseline (30% [18%]; P- 0.020). Pulmonary function, QOL, and asthmatic symptoms did not significantly worsen despite reduction in prednisone dose. All patients who completed the study tolerated clarithromycin therapy.
  
  
  CONCLUSIONS
  In this pilot study of patients with corticosteroid-dependent asthma, 6-week clarithromycin 500 mg BID was clinically effective in allowing a reduction in prednisone dosage, without worsening pulmonary function, QOL, or asthmatic symptoms. In addition, clarithromycin was well tolerated, with only 1 patient discontinuing therapy due to treatment-related nausea.
authors.affiliation: Pulmonary Associates, University of Arizona, Phoenix, Arizona, USA ; Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois , USA.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Gotfried
authors.affiliation: Department of Clinical Pharmacy, University of Colorado Health Science Center, Denver Colorado, USA.
authors.forename: Rose
authors.initials: R
authors.lastname: Jung
authors.affiliation: Veterans Affairs Cooperative Study Program, Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico, USA.
authors.forename: Chad R
authors.initials: CR
authors.lastname: Messick
authors.affiliation: Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois , USA.
authors.forename: Israel
authors.initials: I
authors.lastname: Rubinstein
authors.affiliation: Department of Clinical Sciences and Administration, University of Houston College of Pharmacy, Houston, Texas, USA.
authors.forename: Kevin W
authors.initials: KW
authors.lastname: Garey
authors.affiliation: Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois , USA.
authors.forename: Keith A
authors.initials: KA
authors.lastname: Rodvold
authors.affiliation: Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois , USA.
authors.forename: Larry H
authors.initials: LH
authors.lastname: Danziger
keywords: clarithromycin; corticosteroid-dependent asthma; prednisone; steroid-sparing effect