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Mometasone furoate dry powder inhaler (MF-DPI) improves FEV1, symptoms, and quality of life and reduces exacerbations in patients with COPD

University of Wisconsin, Madison, WI

PURPOSE: To compare the efficacy and safety of MF-DPI 800 mcg once daily in the evening (qd PM), MF-DPI 400 mcg bid, and placebo in subjects with COPD not previously treated with inhaled corticosteroids (ICSs).

METHODS: Subjects (N = 911) >=40 years of age and history of COPD were randomized to 52 weeks of double-blind treatment with MF-DPI 800 mcg qd PM, MF-DPI 400 mcg bid, or placebo. All subjects had >=10 pack-years smoking history, and low bronchodilator reversibility. The primary efficacy variables were changes from baseline in post-bronchodilator FEV1 and total COPD symptom scores, and percentage of subjects with >=1 COPD exacerbation. Secondary efficacy variables included response to therapy evaluations and quality of life assessments. Safety variables were also assessed.

RESULTS: In subjects using MF-DPI 800 mcg qd PM and MF-DPI 400 mcg bid, post-bronchodilator FEV1 increased from baseline by 50 mL, compared with a 19 mL decrease in the placebo group (P<.001). Subjects using MF-DPI 400 mcg bid had significant 19% reductions in COPD symptom scores (P<.001 vs placebo). For the pooled MF-DPI subjects, the percentage with COPD exacerbations was significantly reduced; the time to first exacerbation was significantly prolonged (P .043 vs placebo); and significant (P .03 vs placebo) quality of life improvements as measured by the St. George’s Respiratory Questionnaire (SGRQ) were observed. The percentage of subjects with COPD exacerbations was significantly (p = .043) reduced, the time to first exacerbation was significantly (p<.02) prolonged, and exacerbation rates were reduced. MF-DPI was well tolerated, with no unusual or unexpected adverse events.

CONCLUSION: MF-DPI is effective in the treatment of COPD in patients not previously treated with ICSs. Similar effects on lung function and exacerbations are achieved with MF-DPI administered as 800 mcg qd PM and 400 mcg bid. Symptom reduction with 400 mcg bid was not significantly different from that with 800 mcg qd.

CLINICAL IMPLICATIONS: MF-DPI, administered once daily in the evening, is a useful adjunct in the treatment of COPD.

DISCLOSURE: W.W. Busse, Schering-Plough Research Institute