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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...
The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of treatment...
This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.
The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with persistent asthma. All patients will receive 1 day...
This study is designed to provide pivotal confirmation of efficacy and safety data of two doses of indacaterol (150 and 300 µg once daily; o.d.) in patients with moderate to severe COPD. ...
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COPD (chronic obstructive pulmonary disease)
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