The safety and effectiveness of once daily administration of fluticasone propionate/salmeterol 250/50μg - 25/08/11
Abstract |
Rationale |
To evaluate the safety and efficacy of fluticasone propionate/salmeterol 250/50μg once daily in the evening (FSC QD) versus fluticasone propionate 250μg once daily in the evening (FP QD) versus placebo (PLA) in asthma patients who were symptomatic on short-acting beta2-agonists. All treatments were administered via the Diskus®.
Methods |
At baseline, patients had a mean FEV1 of 2.52 L/min and a mean % predicted PM PEF of 77%. Patients were randomized to FSC QD (n=210), FP QD (n=212) or PLA (n=212) for 12-weeks.
Results |
Treatment with FSC QD resulted in significant improvements (p<0.001) in the primary efficacy measure, % predicted PM PEF over Weeks 1-12, compared with FP QD, and treatment with FP QD resulted in significant improvements in % predicted PM PEF (p=0.006) compared with PLA. Also, there were significantly greater improvements in all secondary efficacy measures (% predicted AM PEF, 2-hour post-dose PEF on Day 1, 24-hour albuterol use, and 24-hour asthma symptoms), for FSC versus FP (p≤0.041) except for symptom scores (p=0.076). Likewise, there were significantly greater improvements in all secondary efficacy measures for FP versus PLA (p≤0.001) except, as expected, for 2-hour post-dose PEF. Drug-related adverse events were low (range 4-9%) and similar across treatment groups. Twenty-four hour urinary cortisol excretion was also similar across treatment groups.
Conclusion |
Treatment with FSC was effective as a QD regimen and FSC QD was superior to FP QD in improving overall asthma control. Likewise, FP QD was superior to PLA in improving overall asthma control. (SAS30022)
Le texte complet de cet article est disponible en PDF.![]() | Funding: GlaxoSmithKline |
Vol 113 - N° 2S
P. S117 - février 2004 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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