Chest
Clinical Investigations: AsthmaA Dose-Ranging Study of Fluticasone Propionate Administered Once Daily via Multidose Powder Inhaler to Patients With Moderate Asthma
Section snippets
Patients
Male and female patients (≥ 12 years old) were enrolled in the study if they had at least a 6-month history of chronic asthma, as defined by the American Thoracic Society,13 which required daily pharmacotherapy over the 6 months immediately prior to the study. Patients were required to have a baseline FEV1 of 45 to 75% of the values predicted by Polgar and Promadhat14 (patient ages 12 to 17 years) and Crapo et al15 (patient age, ≥ 18 years) with an adjustment for a 12% reduction in predicted
Results
A total of 330 patients who met entry criteria were enrolled in the study at 21 clinical sites. A slightly higher percentage of patients received inhaled corticosteroid therapy (55%) thanβ 2-agonists alone (45%). Across treatment groups, concurrent salmeterol use ranged from 27 to 33% of patients, while theophylline use ranged from 19 to 29% of patients. Demography, asthma history, and baseline pulmonary function test results were not significantly different between treatment groups (Table 1).
Discussion
This study demonstrated that once-daily treatment with fluticasone propionate, 100, 200, or 500 μg, via a multidose powder inhaler was effective in patients with moderate asthma, and resulted in improvements in measures of clinical efficacy such as FEV1, morning and evening PEF, duration of study participation, asthma symptoms, nighttime awakenings, and albuterol use. Fluticasone propionate was well tolerated, with no dose-related increases in drug-related adverse events or HPA-axis suppression.
ACKNOWLEDGMENTS
We would like to thank the following for their contributions to this study: D. Chardon, MD; R. Cohen, MD; W.T. Ellison, MD; C.F. LaForce, MD; S.P. Galant, MD; G. Greenwald, MD; W. Howland, MD; H.B. Kaiser, MD; J.P. Karpel, MD; J. Kemp, MD; E.M. Kerwin, MD; W. Lumry, MD; M.J. Noonan, MD; E.J. Schenkel, MD; W.E. Stricker, MD, J.H. VanBavel, MD; and S.A. Wool, MD. We would also like to thank Shehnaz Gangjee, PhD, for assistance in writing this manuscript.
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This study was supported by a grant from Glaxo Wellcome Inc.
Portions of this manuscript were presented in May 1997 at the Annual Meeting of the American Thoracic Society in San Francisco, CA.