A comparison of multiple doses of fluticasone propionate and beclomethasone dipropionate in subjects with persistent asthma☆,☆☆,★
Section snippets
Subjects
Three hundred ninety-nine subjects were enrolled in this study. Eligible subjects were nonsmoking males and females aged 12 years or older with an established diagnosis of chronic asthma requiring daily inhaled corticosteroid therapy for at least 6 months before the study. Only subjects using 8 to 12 puffs/day of either beclomethasone dipropionate or triamcinolone acetonide for at least 1 month before the study were eligible for enrollment. In addition, subjects were required to have an FEV1
Disposition and demographics
There were no statistically significant differences between treatments groups at baseline (Table I).Empty Cell FP 88μg FP 220μg BDP 168μg BDP 336μg No. of subjects 99 104 101 95 Mean age, y (±SEM) 38.4 (±1.4) 37.8 (±1.3) 41.5 (±1.5) 39.8 (±1.7) Range 13-70 13-72 13-83 12-72 Sex, n (%) M 46 (46%) 50 (48%) 32 (3%) 39 (41%) F 53 (54%) 54 (52%) 69 (68%) 56 (59%) Ethnic origin, n (%) White 91 (92%) 99 (95%) 91 (90%) 91 (96%) Black 6 (6%) 4 (4%) 6 (6%) 3 Other 2 (2%) 1 (<1%) 4 (4%) 1 (1%) Mean, % predicted FEV1 (±SEM)
DISCUSSION
Comparative efficacy studies of inhaled corticosteroids need to be carefully designed with respect to dose, patient population, and clinical endpoints. It has been suggested that meaningful comparisons of inhaled corticosteroids should be based on low, clinically comparable doses using meaningful endpoints (eg, improved asthma control) in subjects treated for an appropriate period of time.23 When beclomethasone dipropionate and triamcinolone acetonide were compared as suggested above, there was
Acknowledgements
We thank Michael Wisniewski, PhD, for his statistical analyses and the FLTA4015 Clinical Study Group.
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