A randomized, double-blind, placebo-controlled, 4 period incomplete block cross-over, multi-center, multiple dose (7 days) dose-ranging study to assess the efficacy and safety of 4 doses of NVA237 in ...

Update Il y a 3 ans
Reference: EUCTR2007-000642-13

A randomized, double-blind, placebo-controlled, 4 period incomplete block cross-over, multi-center, multiple dose (7 days) dose-ranging study to assess the efficacy and safety of 4 doses of NVA237 in patients with stable Chronic Obstructive Pulmonary Disease (COPD), compared to seven days treatment with tiotropium (18µg once daily, open label) as an active control

Woman and Man

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Extract

To evaluate the bronchodilatory efficacy of NVA237 in patients with stable COPD in terms of through FEV1 (mean of 23h 15 min & 23h 45 min post dose) following 7 days of treatment, by comparing four doses of NVA237 (12.5, 25, 50 &100 micrograms o.d.) with placebo delivered by the single Dose Dry Powder Inhaler (SDDPI).


Inclusion criteria

  • Chronic Obstructive Pulmonary Disease (COPD)