Gd. Raphael et al., A comparison of multiple doses of fluticasone propionate and beclomethasone dipropionate in subjects with persistent asthma, J ALLERG CL, 103(5), 1999, pp. 796-803
Background: Inhaled corticosteroids are recommended for the treatment of pe
rsistent 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 fluti
casone propionate (88 mu g twice daily and 220 mu g twice daily) with 2 dos
es of beclomethasone dipropionate (168 mu g twice daily and 336 mu g 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 v
alue. Clinic visits, including spirometry; were conducted every 1 to 2 week
s. Subjects recorded symptoms, use of albuterol, and peak expiratory Bows o
n daily diary cards.
Results: Fluticasone propionate treatment resulted in significantly (P less
than or equal to .034) greater improvements in objective pulmonary functio
n parameters than did beclomethasone dipropionate; treatment and significan
tly greater reductions in daily albuterol use (P less than or equal to .010
) and asthma symptoms (P less than or equal to .027). Both low-dose (88 mu
g twice daily) and medium-dose (220 mu g twice daily) fluticasone propionat
e significantly increased FEV1 compared with higher doses of beclomethasone
dipropionate (P = .006), Low-dose and medium-dose fluticasone propionate i
mproved 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 b
eclomethasone dipropionate. The adverse event profiles were similar for bot
h medications.
Conclusion: Fluticasone propionate provides greater asthma control at rough
ly half the dose of beclomethasone dipropignate, with a comparable adverse
event profile.