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).
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.
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.
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.
MF-DPI, administered once daily in the evening, is a useful adjunct in the treatment of COPD.
W.W. Busse, Schering-Plough Research Institute