Mark H Gotfried1, Rose Jung2, Chad R Messick3, Israel Rubinstein4, Kevin W Garey5, Keith A Rodvold4, Larry H Danziger4. 1. Pulmonary Associates, University of Arizona, Phoenix, Arizona, USA ; Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois , USA. 2. Department of Clinical Pharmacy, University of Colorado Health Science Center, Denver Colorado, USA. 3. Veterans Affairs Cooperative Study Program, Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico, USA. 4. Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois , USA. 5. Department of Clinical Sciences and Administration, University of Houston College of Pharmacy, Houston, Texas, USA.
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-weekclarithromycin 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.
RCT Entities:
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: J D Spahn; D A Fost; R Covar; R J Martin; E E Brown; S J Szefler; D Y Leung Journal: Ann Allergy Asthma Immunol Date: 2001-12 Impact factor: 6.347