Abstract | BACKGROUND: Despite current recommendations, many patients with persistent asthma are still treated with bronchodilators alone. OBJECTIVE: The safety and efficacy of two once daily dosing regimens (200 microg and 400 microg) of mometasone furoate (MF) administered in the morning by using a dry-powder inhaler (DPI) were compared with those of a twice daily dosing regimen (200 microg administered twice daily) in patients with mild-to-moderate persistent asthma previously taking only inhaled beta(2)-adrenergic agonists. METHODS: All patients (306 patients; age range, 12-70 years) were given a diagnosis of asthma for at least 6 months before enrollment in this 12-week, placebo-controlled, double-blind, randomized study. The primary efficacy variable was change in FEV(1) from baseline to endpoint (last evaluable visit). RESULTS: At endpoint, FEV(1) was significantly improved (P < or =.02) after MF-DPI 400 microg once daily morning treatment and MF-DPI 200 microg twice daily treatment (16.0% and 16.1%, respectively) compared with placebo (5.5%). The improvement seen with MF-DPI 200 microg once daily morning treatment (10.4%) was not significantly different from that with placebo. Secondary efficacy variables also showed significant improvement for the MF-DPI 400 microg once daily morning treatment group and the MF-DPI 200 microg twice daily treatment group compared with the placebo group. All doses of MF administered by means of a DPI were well tolerated. CONCLUSION: This is the first study to demonstrate that a total daily dose of 400 microg of MF administered by means of a DPI is an effective treatment for patients with mild-to-moderate persistent asthma previously taking only inhaled beta(2)-adrenergic agonists. This treatment was equally effective when administered either as a once daily or twice daily regimen.
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Authors | J P Kemp, R B Berkowitz, S D Miller, J J Murray, K Nolop, J E Harrison |
Journal | The Journal of allergy and clinical immunology
(J Allergy Clin Immunol)
Vol. 106
Issue 3
Pg. 485-92
(Sep 2000)
ISSN: 0091-6749 [Print] United States |
PMID | 10984368
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Anti-Inflammatory Agents
- Pregnadienediols
- Mometasone Furoate
- Albuterol
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Topics |
- Adolescent
- Adult
- Aged
- Albuterol
(administration & dosage, adverse effects)
- Anti-Inflammatory Agents
(administration & dosage, adverse effects)
- Asthma
(drug therapy)
- Circadian Rhythm
- Drug Administration Schedule
- Female
- Humans
- Male
- Middle Aged
- Mometasone Furoate
- Pregnadienediols
(administration & dosage, adverse effects)
- Respiratory Function Tests
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