NVA237 is a novel, once daily inhaled long-acting muscarinic antagonist administered via a dry powder inhaler. This study aimed to assess the 24-h bronchodilatory effect following 14 days of treatment with inhaled NVA237 in patients with mild, moderate or severe COPD.
This was a randomized, double-blind, placebo-controlled, two-period, crossover, multicenter study. A total of 33 patients (≥40 years; smoking history of ≥10 pack-years) were randomized to receive NVA237 50 μg once daily followed by placebo or placebo followed by NVA237 50 μg for 14 days. Treatment periods were separated by a 7–14 day washout period. The primary variable was the mean forced expiratory volume in 1 s (FEV1) derived from the area under the curve (AUC) between 0 and 24 h post-dose on Day 14.
The 24-h FEV1 profiles showed a consistent bronchodilator effect for NVA237 versus placebo on Day 14. Least square (LS) mean difference in FEV1 AUC0–24 h values between NVA237 and placebo was 163 mL (P < 0.001). There were significant increases in mean FEV1 AUC0–12 h (LS mean difference 165 mL, P = 0.001) and FEV1 AUC12–24 h (161 mL, P < 0.001) versus placebo. NVA237 significantly improved peak FEV1 (by 208 mL, P < 0.001) and trough FEV1 (by 154 mL, P = 0.003) versus placebo on Day 14. NVA237 was well tolerated; all adverse events were mild or moderate in intensity and not related to study drug.
NVA237 50 μg once daily was well tolerated and showed significant and sustained 24-h bronchodilation in patients with COPD.
