Impact of inhaled salmeterol/fluticasone propionate combination product versus budesonide on the health-related quality of life of patients with asthma. American journal of respiratory medicine : drugs, devices, and other interventions. [Am J Respir Med] Journal article | | Title | 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 | | Institution | Department of Clinical Epidemiology and Biostatistics, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada. juniper@qoltech.co.uk | | Source | Am J Respir Med 2002; 1(6):435-40. | | MeSH | Administration, Inhalation
Adolescent
Adult
Aged
Albuterol
Androstadienes
Asthma
Bronchodilator Agents
Budesonide
Comparative Study
Double-Blind Method
Drug Combinations
Female
Humans
Male
Middle Aged
Quality of Life
Questionnaires
| | 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 > 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. | | Language | eng | | Pub Type(s) | Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
| | PubMed ID | 14720030 |
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