Effect of Indacaterol on Inspiratory Capacity (IC)
NCT01012765 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 173
Last updated 2016-02-17
Summary
This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In particular, spirometric timepoints are included to elucidate the peak-IC in a period of approximately 4 hour post inhalation
Conditions
Interventions
- DRUG
-
Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
- DRUG
-
Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
- DRUG
-
Placebo to indacaterol o.d. delivered via SDDPI
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-11-30
- Primary Completion
- 2011-01-31
Countries
- Germany
Study Locations
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