title: One-year treatment with mometasone furoate in chronic obstructive pulmonary disease.
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.
authors.affiliation: Department of Medicine, University Hospital Aintree, Liverpool, UK. pmacal@liverpool.ac.uk
authors.forename: Peter M A
authors.initials: PM
authors.lastname: Calverley
authors.forename: Stephen
authors.initials: S
authors.lastname: Rennard
authors.forename: Harold S
authors.initials: HS
authors.lastname: Nelson
authors.forename: Jill P
authors.initials: JP
authors.lastname: Karpel
authors.forename: Eduardo H
authors.initials: EH
authors.lastname: Abbate
authors.forename: Paul
authors.initials: P
authors.lastname: Stryszak
authors.forename: Heribert
authors.initials: H
authors.lastname: Staudinger
mesh_terms: D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D038622:Internationality; D008137:Longitudinal Studies; D008297:Male; D000068656:Mometasone Furoate; D011244:Pregnadienediols / Q000008:administration & dosage*; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis* / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D011244:Pregnadienediols; D000068656:Mometasone Furoate