A 12 week treatment, multi-center, randomized, parallel group, double blind, double dummy study to assess the superiority of indacaterol (150 μg o.d.) via a SDDPI in patients with moderate to severe C...

Update Il y a 4 ans
Reference: EUCTR2008-005146-23

A 12 week treatment, multi-center, randomized, parallel group, double blind, double dummy study to assess the superiority of indacaterol (150 μg o.d.) via a SDDPI in patients with moderate to severe COPD, using salmeterol (50 μg b.i.d.) as an active comparator delivered via a DISKUS inhaler

Woman and Man

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Extract

To demonstrate the superiority of indacaterol (150 μg o.d.) versus salmeterol (50 μg b.i.d.) with respect to standardized area under the curve (AUC) for forced expiratory volume in one second (FEV1) between 5 min and 11 h 45 min after the morning dose on day 84 of treatment in patients with moderate to severe COPD.


Inclusion criteria

  • COPD (Chronic Obstructive Pulmonary Disease)