Administration of budesonide once daily by means of Turbuhaler to subjects with stable asthma☆,☆☆,★
Section snippets
Subjects
Adult male and female subjects, 18 to 70 years of age, with a diagnosis of asthma as defined by the American Thoracic Society of at least 6 months’ duration, were recruited at 20 centers. All participants had reversible airway obstruction, as demonstrated by an increase in FEV 1 of greater than 15% after the administration of 2 to 4 puffs of albuterol. Subjects who were using inhaled GCSs at study entry (GCS group) were included and consisted of individuals who took inhaled beclomethasone
Subjects
A total of 309 subjects was randomized to study treatment: 104 to the placebo group and 103 and 102 to the budesonide 200 μg and 400/200 μg groups, respectively. Clinical and demographic characteristics at enrollment (screen) are shown in Table I . Four subjects (2 in each of the placebo and 200 μg budesonide groups) discontinued before any double-blind measurements could be obtained and were not included in efficacy analyses. There were no significant differences among the groups in sex, age,
DISCUSSION
This study was undertaken to determine whether single daily administration of inhaled budesonide in 200 and 400 μg doses could provide safe and effective treatment in a large population of subjects with stable asthma. Significant improvements in pulmonary function, reduction of symptoms, decreased use of β-agonists, and improvements in health-related quality of life occurred with both doses of budesonide and were maintained throughout the study. The results with the 2 budesonide schedules were
Acknowledgements
Additional Investigators who participated in this study as members of the Pulmicort Turbuhaler Once Daily Study Group are as follows: Paul Chervinsky, MD, The New England Research Center, Inc (North Dartmouth, Mass); Ben Carasso, MD, Chicago Center for Clinical Research (Chicago, Ill); Joseph D. Diaz, MD, Allergy and Asthma Research Center (San Antonio, Tex); Sidney Friedlaender, MD, Clinical Investigative Site (Gainesville, Fla); David Graft, MD, Park Nicollett Medical Center (Minneapolis,
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Supported by a grant from Astra Draco AB, Lund, Sweden.
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Reprint requests: E. R. McFadden, MD, University Hospitals of Cleveland, 11100 Euclid Ave, Cleveland, OH 44106.
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