Research

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

Peter MA Calverley¹ , Stephen Rennard² , Harold S Nelson³ , Jill P Karpel⁴ , Eduardo H Abbate⁵ , Paul Stryszak⁶ and Heribert Staudinger⁶

¹  Department of Medicine, University Hospital Aintree, Liverpool, UK

²  University of Nebraska Medical Center, Omaha, NE, USA

³  Department of Medicine, National Jewish Medical and Research Center, Denver, CO, USA

⁴  North Shore University Hospital, New Hyde Park, NY, USA

⁵  Asociacion Argentina de Medicina Respiratoria, Buenos Aires, Argentina

⁶  Schering-Plough Research Institute, Kenilworth, NJ, USA

author email corresponding author email

Respiratory Research 2008, 9:73doi:10.1186/1465-9921-9-73

Published:	13 November 2008

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 μg QD PM, MF-DPI 400 μg 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 μg QD PM and 400 μg 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 μg 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 ≤ 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.