Study:
A 26-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Two Doses of Indacaterol (Selected From 75, 150, 300 & 600 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease Using Blinded Formoterol (12 µg b.i.d.) and Open Label Tiotropium (18 µg o.d.) as Active Controls
Rationale:
n/a
Purpose:
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
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Pulmonary Disease, Chronic Obstructive
COPD
Lung Diseases, Obstructive |
Drug: Indacaterol
Drug: Formoterol (12 µg b.i.d.)
Drug: Tiotropium (18 µg o.d.)
Drug: Placebo to Indacaterol
Drug: Placebo to Formoterol |
Phase 2/Phase 3 |
Verified by
Novartis
July, 2011
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov identifier: NCT00463567
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cleveland Clinic
Cleveland, Ohio 44195
United States
Novartis Pharmaceuticals., Study Chair