Dose-related efficacy of budesonide administered via a dry powder inhaler in the treatment of children with moderate to severe persistent asthma☆,☆☆,★,★★,♢
Section snippets
Subjects
Pediatric subjects with a minimum history of 6 months of inhaled GCS-dependent asthma with perennial symptoms were enrolled into the study at 25 centers in the United States. To be eligible for inclusion, patients had to be aged 6 to 18 years and to have had reversible airway obstruction at the screening visit, defined by a 15% increase in forced expiratory volume in 1 second after inhalation of 180 or 360 μg of the β2-agonist albuterol (Proventil). In addition, an FEV1 of 50% or greater, and
Subjects
Children (314 boys and 90 girls) were randomly selected, and 305 of the 404 subjects completed the double-blind period. Baseline screening characteristics were comparable between the four treatment groups (Table I).
Subjects in all four groups had a comparable range of mean percentage of predicted FEV1 (75%), and of morning PEF values at baseline, as well as comparable use of β2-agonists (Tables I and II).
Empty Cell Empty Cell Budesonide (μg bid) Characteristic Placebo 100 200 400
DISCUSSION
The data presented in this report are relevant to the ongoing development of optimal guidelines for asthma management.3, 13 These and other guidelines have identified the need for an increased level of asthma control. The more aggressive goals for treatment of asthma have also resulted in an increased use of inhaled GCS in mild to moderate persistent asthma in children. However, there are few data in children to support the recommended use of individual dose-titration when inhaled GCS is used.
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Cited by (0)
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From the Carolina Allergy and Asthma Consultants, Raleigh, North Carolina; the Pediatric Allergy Association, West Hartford, Connecticut; Colorado Asthma and Allergy, Aurora, Colorado; the Allergy and Asthma Rochester Resource Center, Fairport, New York; and the National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado.
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Supported by a grant from Astra, USA. All authors have had research funded through grants from Astra, USA, and have had consultant roles with Astra, USA.
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Reprint requests: Gail Shapiro, MD, 4540 Sand Point Way, NE, Suite 200, Seattle, WA 98105.
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*See Appendix.
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