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1: Respir Res. 2008 Nov 13;9(1):73. [Epub ahead of print]
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One-Year treatment with mometasone furoate in chronic obstructive pulmonary disease.

Calverley PM, Rennard S, Nelson HS, Karpel JP, Abbate EH, Stryszak P, Staudinger H.

ABSTRACT: Many patients with chronic obstructive pulmonary disease (COPD) are treated with twice daily (BID) inhaled corticosteroids (ICS). This study evaluated whether daily PM mometasone furoate administered via a dry powder inhaler (MF-DPI) was equally effective compared to twice daily dosing. In a 52-week, randomized, double-blind, placebo-controlled study, 911 subjects with moderate-to-severe COPD managed without ICS received MF-DPI 800 mcg QD PM, MF-DPI 400 mcg BID, or placebo. The change from baseline in postbronchodilator forced expiratory volume in 1 second (FEV1), total COPD symptom scores, and health status as well as the percentage of subjects with a COPD exacerbation were assessed. Adverse events were recorded. Mometasone furoate administered via a dry powder inhaler 800 mcg QD PM and 400 mcg BID significantly increased postbronchodilator FEV1 from baseline (50 mL and 53 mL, respectively, versus a 19-mL decrease for placebo; P<0.001). The percentage of subjects exacerbating was significantly lower in the pooled MF-DPI groups than in the placebo group (P=0.043). Subjects receiving MF-DPI 400 mcg BID reported a statistically significant (19%) reduction in COPD symptom scores compared with placebo (P<0.001). Health status as measured with St. George's Respiratory Questionnaire (SGRQ) improved significantly in all domains (Total, Activity, Impacts, and Symptoms) in the pooled MF-DPI groups versus placebo (P[less than or equal to]0.031). MF-DPI treatment was well tolerated. Once-daily MF-DPI improved lung function and health status in subjects with moderate-to-severe COPD and was comparable to BID MF-DPI.

PMID: 19014549 [PubMed - as supplied by publisher]