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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

  • Original Research Article
  • Published:
American Journal of Respiratory Medicine

Abstract

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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Acknowledgements

This study was sponsored by GlaxoSmithKline [protocol reference SAS40006 (SERL04)]. Seretide™, Advair™, Diskus™and Accuhaler™are trademarks of the GlaxoSmithKline group. Pulmicort™and Turbuhaler™are trademarks of AstraZeneca.

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Authors and Affiliations

  1. Department of Clinical Epidemiology and Biostatistics, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada

    Elizabeth F. Juniper

  2. Institute of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

    Christine Jenkins

  3. GlaxoSmithKline Research & Development Ltd, Greenford, UK

    Martin J. Price & Mark H. James

Authors
  1. Elizabeth F. Juniper
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  2. Christine Jenkins
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  3. Martin J. Price
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  4. Mark H. James
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Correspondence to Elizabeth F. Juniper.

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Juniper, E.F., Jenkins, C., Price, M.J. et al. Impact of Inhaled Salmeterol/Fluticasone Propionate Combination Product versus Budesonide on the Health-Related Quality of Life of Patients with Asthma. Am J Respir Med 1, 435–440 (2002). https://doi.org/10.1007/BF03257170

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