| Autor: |
Bousquet, Jean, Menten, Joris, Tozzi, Carol A., Polos, Peter G. |
| Předmět: |
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| Zdroj: |
Journal of Applied Research; 2005, Vol. 5 Issue 3, p402-414, 13p, 1 Diagram, 2 Charts, 2 Graphs |
| Abstrakt: |
Objective: Asthma consensus guidelines recommend the use of a controller agent to control asthma symptoms and reduce inflammation in patients with mild asthma. The objective of this study was to compare montelukast to inhaled fluticasone on the percentage of asthma-free days in patients with mild persistent asthma during 48 weeks of active treatment. Methods: This was a randomized, multicenter study with a 3-week single-blind run-in period, followed by a 12-week double-blind active treatment period, and a 36-week open-label active treatment period. Patients (aged 15 to 80 years) with mild persistent asthma as established by the Global Initiative for Asthma (GINA) guidelines were randomized to receive oral montelukast 10 mg (n=325) or fluticasone UK) pg (n=320) twice daily by metered-dose inhaler. An analysis of covariance model was used to analyze the primary endpoint of asthma-free days. Montelukast would be considered at least as effective as fluticasone if the treatment difference (average percentage of asthma-free days on fluticasone minus average percentage of asthma-free days on montelukast) was below 10% (3 days/ month). Secondary endpoints were "as-needed" β-agonist use, days with symptoms, rescue-free days, asthma-specific quality of life, forced expiratory volume in 1 second (FEV1), morning peak expiratory flow, asthma attacks, nocturnal awakenings, patient global assessment of asthma, blood eosinophil count, and safety and tolerability. Results: Patients taking fluticasone had 6.44% (9-5% confidence interval [CI] 2.24. 10.64) more asthma-free days than did patients taking montelukast (<2 days/month/patient).The CI included the non-inferiority boundary of 10%. Both montelukast and fluticasone showed an improvement in asthma-related efficacy endpoints, except FEV1, which was improved only for patients taking fluticasone. Both montelukast and fluticasone were well tolerated. Conclusions: Both agents demonstrated efficacy for most of the primary and secondary endpoints. Results for most endpoints were essentially equivalent: however, patients taking fluticasone had more asthma-free days and improved FEV1 than did patients taking montelukast. [ABSTRACT FROM AUTHOR] |
| Databáze: |
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