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Randomized Controlled Trial
. 2008 Nov 13;9(1):73.
doi: 10.1186/1465-9921-9-73.

One-year treatment with mometasone furoate in chronic obstructive pulmonary disease

Peter M A Calverley  1 , Stephen Rennard, Harold S Nelson, Jill P Karpel, Eduardo H Abbate, Paul Stryszak, Heribert Staudinger
Affiliations
Randomized Controlled Trial

One-year treatment with mometasone furoate in chronic obstructive pulmonary disease

Peter M A Calverley et al. Respir Res. .

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 microg QD PM, MF-DPI 400 microg 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 microg QD PM and 400 microg 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 microg 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 < or = 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.

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Figures

Figure 1
Figure 1
Disposition of study subjects.
Figure 2
Figure 2
Changes from baseline in postbronchodilator FEV1. BID = twice daily; FEV1 = forced expiratory volume in 1 second; LA = longitudinal average; MF-DPI = mometasone furoate delivered via a dry powder inhaler; QD PM = once-daily in the evening. *P ≤ 0.001 vs placebo; †P ≤ 0.006 vs placebo.
See this image and copyright information in PMC

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