Administration of budesonide once daily by means of Turbuhaler to subjects with stable asthma,☆☆,

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Abstract

Background: Optimal management of chronic, mild-to-moderate asthma with inhaled steroids may include use of the lowest possible doses, as recommended in guidelines, and a reduction in the frequency of daily administration for greater convenience. Lower doses and once daily treatment with inhaled steroids must be rigorously evaluated in controlled clinical trials. Objectives: The objective of this study was to assess the efficacy and safety of once daily treatment with budesonide in subjects with stable asthma. Methods: Once daily budesonide was assessed in 309 adult subjects, including those who were and were not using an inhaled steroid at baseline. The subjects were stratified by inhaled steroid use and randomly assigned to one of 3 treatments: 200 μg budesonide, 400 μg budesonide, or placebo administered by means of Turbuhaler once daily in the morning for 6 weeks. Beyond this point, treatment was continued unchanged for another 12 weeks (maintenance) in those receiving 200 μg budesonide once daily and placebo. In those who received 400 μg budesonide once daily, the dose was reduced to 200 μg once daily at week 6 and held constant for the remaining 12 weeks (400/200 μg group). Primary efficacy endpoints were mean change from baseline in FEV 1 and morning peak expiratory flow. Results: Once daily budesonide was well tolerated and resulted in significant improvements in all efficacy endpoints, even though baselines were well stabilized. Baseline lung function was elevated with little room for improvement; however, mean increases in FEV 1 during the maintenance period were 0.10 L and 0.11 L in the 200 μg and 400/200 μg groups, respectively, versus a decrease of –0.09 L in the placebo arm ( P < .001). Results for peak expiratory flow were similar. Significant improvements in secondary endpoints, including symptoms, β-agonist use, and quality of life, also developed with budesonide 200 and 400 μg once daily. Conclusion: Inhaled budesonide, in doses as low as 200 μg, may be an appropriate introductory or maintenance dose in subjects with stable, mild-to-moderate asthma. (J Allergy Clin Immunol 1999;104:46-52.)

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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