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Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 & 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
Indacaterol 75µg o.d, indacaterol 150 µg o.d., indacaterol 300 µg o.d., indacaterol 600 µg o.d., Formoterol (12 µg b.i.d), Tiotropium (18 µg o.d.), placebo
Pinnacle Research Group, LLC
Published on BioPortfolio: 2014-08-27T03:38:57-0400
This study is designed to assess the efficacy and long-term safety data for the 300 and 600 µg doses of indacaterol when delivered via a single dose dry powder inhaler (SDDPI) in patients...
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