Fluticasone propionate powder and lack of clinically significant effects on hypothalamic-pituitary-adrenal axis and bone mineral density over 2 years in adults with mild asthma☆,☆☆,★
Section snippets
Patients
Male (18 to 50 years) and female (18 to 40 years) patients, diagnosed with asthma according to the American Thoracic Society definition,14 were enrolled in the study if they had a medical history of asthma for at least 6 months before enrollment, an FEV1 of at least 60% of predicted value, and limited previous corticosteroid therapy (ie, none during the month before the study, ≤4 weeks of cumulative oral therapy, and ≤1 year of cumulative total therapy from any route). Historical medical
Study population
Demography and pulmonary function of the 64 randomized patients were similar across treatment groups (Table I).Empty Cell Placebo FP 500 μg BID No. of patients 32 32 Sex, M/F (%) 81/19 91/9 Age, y (mean ± SEM) 31.1 ± 1.3 28.0 ± 1.2 Range 18-49 18-41 Height, in (mean ± SEM) 69.2 ± 0.7 69.7 ± 0.5 Range 62-76 65-80 Weight, lbs (mean ± SEM) 187 ± 4.9 177 ± 5.7 Range 126-261 125-238 No. completed 17 (53%) 21 (66%) No. withdrawn 15 (47%) 11 (34%) Reasons for withdrawal
DISCUSSION
Few studies have prospectively evaluated the effects of long-term administration of high doses of inhaled corticosteroids on the HPA axis. Prior use of systemic corticosteroids has been a confounding issue in many studies. This trial was designed to evaluate the effect of treatment over 2 years with 1000 μg of fluticasone propionate on adrenal function (at baseline and after stimulation with exogenous adrenocorticotrophic hormone) in patients with minimal prior use of systemic corticosteroids.
Acknowledgements
We thank the following for their contributions to the study: J. Kemp, MD, San Diego, Calif; M. Mass, MD, FACP, Jacksonville, Fla; and J. Pinnas, MD. We would also like to thank Shehnaz Gangjee for writing this manuscript.
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