American Journal of Respiratory Medicine

, Volume 1, Issue 6, pp 435–440

Impact of Inhaled Salmeterol/Fluticasone Propionate Combination Product versus Budesonide on the Health-Related Quality of Life of Patients with Asthma


    • Department of Clinical Epidemiology and BiostatisticsMcMaster University Faculty of Health Sciences
  • Christine Jenkins
    • Institute of Respiratory MedicineRoyal Prince Alfred Hospital
  • Martin J. Price
    • GlaxoSmithKline Research & Development Ltd
  • Mark H. James
    • GlaxoSmithKline Research & Development Ltd
Original Research Article

DOI: 10.1007/BF03257170

Cite this article as:
Juniper, E.F., Jenkins, C., Price, M.J. et al. Am J Respir Med (2002) 1: 435. doi:10.1007/BF03257170


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 ≥12 years with moderate-to-severe asthma uncontrolled by inhaled corticosteroids.

Methods: Patients received, twice daily, either salmeterol/fluticasone propionate 50/250μ,g (Seretide™/Advair™1) via Diskus™ inhaler (n = 55) or budesonide 800μg (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 ≥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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© Adis International Limited 2002