Abstract |
We conducted this study to compare the efficacy and safety of once-daily mometasone furoate (MF) administered by dry powder inhaler (DPI) with once-daily budesonide (BUD)-DPI and placebo in patients with moderate persistent asthma previously using twice-daily inhaled corticosteroids. A total of 262 patients (> or = 12 years of age) with moderate persistent asthma were randomised to once-daily morning treatment with MF-DPI 440 microg (metered dose), BUD-DPI 400 microg (metered dose), or placebo in an eight-week, multicentre, placebo-controlled, double-blind, double-dummy study. The primary efficacy variable was percent change in FEV1 from baseline to endpoint (last evaluable visit). At endpoint, the percent change in FEV1 was significantly greater (p < 0.01) following treatment with MF-DPI 440 microg (8.9%) than with both BUD-DPI 400 microg (2.1%) and placebo (-3.9%). Secondary efficacy variables, including morning and evening peak expiratory flow rates, albuterol use, percentage of asthma symptom-free days, and physician-evaluated response to therapy were also significantly improved at endpoint in the MF-DPI group compared with both the placebo and BUD-DPI groups (p < 0.05). Both active treatments were well tolerated. In conclusion, once-daily treatment in the morning with MF-DPI 440 microg significantly improved pulmonary function and asthma control compared with morning administration of BUD-DPI 400 microg and placebo.
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Authors | J Corren, R Berkowitz, J J Murray, B Prenner |
Journal | International journal of clinical practice
(Int J Clin Pract)
Vol. 57
Issue 7
Pg. 567-72
(Sep 2003)
ISSN: 1368-5031 [Print] India |
PMID | 14529054
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Asthmatic Agents
- Anti-Inflammatory Agents
- Pregnadienediols
- Mometasone Furoate
- Budesonide
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Anti-Asthmatic Agents
(administration & dosage)
- Anti-Inflammatory Agents
(administration & dosage)
- Asthma
(drug therapy)
- Budesonide
(administration & dosage)
- Double-Blind Method
- Drug Administration Schedule
- Forced Expiratory Volume
(drug effects)
- Humans
- Middle Aged
- Mometasone Furoate
- Pregnadienediols
(administration & dosage)
- Respiratory Function Tests
- Treatment Outcome
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