Abstract | BACKGROUND:
Budesonide inhalation powder administered via Turbuhaler ( budesonide Turbuhaler, AstraZeneca LP, Wilmington, DE) is proven efficacious and safe in the treatment of mild to severe asthma. OBJECTIVE: To evaluate the effect of once-daily budesonide Turbuhaler on health-related quality of life (HRQL) in adults with mild to moderate asthma. METHODS: In this double-blind, parallel-group study, 309 asthmatic patients between 18 and 70 years of age were randomized to receive once-daily treatment with budesonide 200 or 400 microg or placebo for 6 weeks. Patients initially receiving 400 microg budesonide had their dose reduced to 200 microg (400/200-microg group), and patients receiving 200 microg (200/200-microg group) or placebo continued to receive their assigned doses for a 12-week maintenance phase. HRQL was evaluated using the Asthma Quality of Life Questionnaire at randomization, week 6, and week 18. RESULTS: Compared with placebo, patients initially receiving 400 and 200 microg budesonide Turbuhaler demonstrated significantly greater HRQL scores at week 6 (P < or = 0.001 and P < or = 0.010, respectively) that were maintained at week 18 (P < or = 0.001). Clinically important (> or = 0.5 unit) improvement in Asthma Quality of Life Questionnaire overall at week 18 was demonstrated by 55% and 43% of patients in the 400/200-microg and 200/200-microg budesonide Turbuhaler groups, respectively. CONCLUSIONS: In patients with mild to moderate asthma, once-daily budesonide Turbuhaler 200 and 400 microg demonstrates statistically significant and clinically important improvements in HRQL that can be maintained with a low dose of 200 microg.
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Authors | Thomas B Casale, Harold S Nelson, James Kemp, Bhash Parasuraman, Thomas Uryniak, Bengt Liljas |
Journal | Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology
(Ann Allergy Asthma Immunol)
Vol. 90
Issue 3
Pg. 323-30
(Mar 2003)
ISSN: 1081-1206 [Print] United States |
PMID | 12669896
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Asthmatic Agents
- Budesonide
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Topics |
- Administration, Inhalation
- Adolescent
- Adult
- Aged
- Anti-Asthmatic Agents
(administration & dosage, adverse effects, therapeutic use)
- Asthma
(diagnosis, drug therapy)
- Budesonide
(administration & dosage, adverse effects, therapeutic use)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Male
- Middle Aged
- Nebulizers and Vaporizers
- Quality of Life
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