A comparison of multiple doses of fluticasone propionate and beclomethasone dipropionate in subjects with persistent asthma,☆☆,

Portions of this manuscript were presented at the American Academy of Allergy, Asthma and Immunology, Washington, DC, March 1998.
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Abstract

Background: Inhaled corticosteroids are recommended for the treatment of persistent asthma. Comparative clinical studies evaluating 2 or more doses of these agents are few. Objective: We sought to compare the efficacy and safety of 2 doses of fluticasone propionate (88 μg twice daily and 220 μg twice daily) with 2 doses of beclomethasone dipropionate (168 μg twice daily and 336 μg twice daily) in subjects with persistent asthma. Methods: Three hundred ninety-nine subjects participated in this randomized, double-blind, parallel-group clinical trial. Eligible subjects were using daily inhaled corticosteroids and had an FEV1 of 45% to 80% of predicted value. Clinic visits, including spirometry, were conducted every 1 to 2 weeks. Subjects recorded symptoms, use of albuterol, and peak expiratory flows on daily diary cards. Results: Fluticasone propionate treatment resulted in significantly (P ≤ .034) greater improvements in objective pulmonary function parameters than did beclomethasone dipropionate treatment and significantly greater reductions in daily albuterol use (P ≤ .010) and asthma symptoms (P ≤ .027). Both low-dose (88 μg twice daily) and medium-dose (220 μg twice daily) fluticasone propionate significantly increased FEV1 compared with higher doses of beclomethasone dipropionate (P = .006). Low-dose and medium-dose fluticasone propionate improved FEV1 by 0.31 L (14%) and 0.36 L (15%), respectively, compared with improvements of 0.18 L (8%) and 0.21 L (9%) with low-dose and medium-dose beclomethasone dipropionate. The adverse event profiles were similar for both medications. Conclusion: Fluticasone propionate provides greater asthma control at roughly half the dose of beclomethasone dipropionate, with a comparable adverse event profile. (J Allergy Clin Immunol 1999;103:796-803.)

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).

. Subject demographics and asthma history

Empty CellFP 88μgFP 220μgBDP 168μgBDP 336μg
No. of subjects9910410195
Mean age, y (±SEM)38.4 (±1.4)37.8 (±1.3)41.5 (±1.5)39.8 (±1.7)
 Range13-7013-7213-8312-72
Sex, n (%)
 M46 (46%)50 (48%)32 (3%)39 (41%)
 F53 (54%)54 (52%)69 (68%)56 (59%)
Ethnic origin, n (%)
 White91 (92%)99 (95%)91 (90%)91 (96%)
 Black6 (6%)4 (4%)6 (6%)3
 Other2 (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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