Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A 12-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Parallel-group Study to Assess the Efficacy of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 μg b.i.d.) as an Active Control
The study will be a 12 week treatment (84 days), parallel group, randomized, double blind,
double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol
(12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (FEV1).
Patients will be enrolled after giving informed consent and then begin a screening/run-in
period for 14 days. Patients will be randomized to one of two treatment groups using an
allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to
formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period
of 12 weeks.
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