A 26-week Extension to a 26-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess Safety, Tolerability and Efficacy of Two Doses of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease
A 26-week Extension to a 26-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess Safety, Tolerability and Efficacy of Two Doses of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease
This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients
Inclusion Criteria:
Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).
In addition the following inclusion/exclusion criteria specified below must be met.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Metaire, Louisiana 70002, United States
Steinfurt-Borghorst, Germany
Hyderabaad, India
Gladakano, Spain
Jerez de Frontera, Spain
Las Palmas de Gran Canarias, Spain
Kartal/Istanbul, Turkey (Türkiye)
Yenisehir/Izmir, Turkey (Türkiye)