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Impact of inhaled salmeterol/fluticasone propionate combination product versus budesonide on the health-related quality of life of patients with asthma.

Author(s): Juniper EF, Jenkins C, Price MJ, James MH

Affiliation(s): Department of Clinical Epidemiology and Biostatistics, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada. juniper@qoltech.co.uk

Publication date & source: 2002, Am J Respir Med., 1(6):435-40.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

OBJECTIVE AND DESIGN: Measurement of health-related quality of life (HR-QOL) may show benefits of asthma treatments not revealed by objective monitoring and can complement clinical and physiological assessments of treatment outcome. HR-QOL was measured in four countries in a multicenter, double-blind, randomized comparison of salmeterol/fluticasone propionate combination and budesonide in patients aged > or =12 years with moderate-to-severe asthma uncontrolled by inhaled corticosteroids. METHODS: Patients received, twice daily, either salmeterol/fluticasone propionate 50/250 microg (Seretide/ Advair) via Diskus inhaler (n = 55) or budesonide 800 microg (Pulmicort) via Turbuhaler (n = 58). Patients completed the Asthma Quality of Life Questionnaire (AQLQ) at baseline and after 12 weeks treatment (or early withdrawal). The analysis included 113 patients. RESULTS: Mean improvement in AQLQ scores achieved clinical importance in all four domains in the salmeterol/fluticasone group (AQLQ change > or =0.5), but in only two domains in the budesonide group. Although the mean overall improvement in AQLQ scores observed in the salmeterol/fluticasone group was significantly greater than that observed in the budesonide group (difference of 0.45; p = 0.002), the difference was less than the minimal important difference (0.5). Nevertheless, further analysis showed that the number-needed-to-treat was only 3.4. This indicates that only 3.4 patients need to be treated with the salmeterol/fluticasone combination for one patient to experience a meaningful improvement in HR-QOL, relative to monotherapy with an increased dose of budesonide. CONCLUSION: Treatment of moderate-to-severe asthma with salmeterol/fluticasone propionate resulted in superior gains in HR-QOL relative to increasing the dose of inhaled corticosteroids.

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