AI Article Synopsis
- The redesign of the dry powder inhaler (DPI) for budesonide aimed to enhance dosing consistency and introduced new dosage options, with DPI-B offering lower doses compared to the earlier DPI-A model.
- Two separate clinical studies evaluated the effectiveness and safety of these inhalers in treating mild-to-moderate asthma in adults and mild asthma in children, measuring outcomes such as lung function and asthma-related symptoms.
- Results indicated that most doses of budesonide significantly improved lung function and reduced asthma symptoms compared to placebo, with no major differences in adverse effects between the active treatment and placebo groups.
Article Abstract
Background: The dry powder inhaler (DPI) device for budesonide inhalation powder 200 microg (DPI-A) was redesigned to improve dosing consistency and provide new features (budesonide inhalation powder 90 microg and 180 microg; DPI-B).
Objective: Two multicenter, parallel-group, double-blind, randomized, 12-week studies compared the efficacy and safety of budesonide delivered via each DPI versus placebo, and the systemic exposure of budesonide from each device.
Methods: Asthmatic adults with mild-to-moderate asthma (N = 621) and patients 6-17 years with mild asthma (N = 516) received budesonide DPI-B 360 microg or DPI-A 400 microg twice-daily (total daily dose 720 microg or 800 microg), budesonide DPI-B 180 microg or DPI-A 200 microg once daily (total daily dose 180 microg or 200 microg), or matching placebo. Change in forced expiratory volume in 1 second (FEV(1)) and secondary variables (asthma symptoms, beta(2)-adrenergic agonist use, peak expiratory flow [PEF], and withdrawals due to worsening asthma) versus placebo were measured.
Results: In both studies, FEV(1) significantly (p < 0.05) improved for all active treatments versus placebo except once-daily budesonide DPI-B 180 mug in adults. In the adult study, significantly (p < 0.05) greater improvements in all secondary variables occurred with all active treatments versus placebo. In the pediatric/adolescent study, improvements in AM/PM PEF were significantly (p
Conclusions: The efficacy and safety of budesonide DPI-A and DPI-B versus placebo were demonstrated across the low to medium inhaled corticosteroid dose range in children >or= 6 years with very mild asthma and adolescents and adults with mild-to-moderate asthma. The study is limited by the evaluation of only two doses for each product in both studies. Additionally, the studies were not designed to test equivalence or noninferiority between the active products. Pharmacokinetic characterization was limited because of the small sample sizes.
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| http://dx.doi.org/10.1185/030079908x297240 | DOI Listing |
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