Efficacy, safety, and tolerability of NVA237 compared to tiotropium in patients with chronic obstructive pulmonary disease (COPD)

Update Il y a 4 ans
Reference: EUCTR2011-000960-93

Woman and Man

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Extract

To demonstrate non-inferiority of NVA237 50 μg o.d. versus tiotropium 18 μg o.d. with respect to trough Forced Expiratory Volume in one second (trough FEV1) after 12 weeks (84 days) of treatment in patients with moderate to severe COPD (GOLD, 2010). Trough refers to the mean of FEV1 at 23h 15 mins and 23h 45 mins after the morning dose of study drug.


Inclusion criteria

  • Chronic Obstructive Pulmonary Disease (COPD)