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Indacaterol in COPD with destroyed lung by tuberculosis
NCT01778062Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2013
- Primary completion
- Sep 2014
- Countries
- 1
- Sponsor
- Novartis
- Modality
- Small Molecules
- Drugs
- indacaterol
- Conditions
- chronic obstructive pulmonary disease (COPD)
01
Overview
Phase 3, randomised, double-blind trial in chronic obstructive pulmonary disease (COPD) comparing Indacaterol with Placebo (2 arms). Primary endpoint: Trough Forced Expiratory Volume in One Second Change at 8 weeks. Started Feb 2013; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Indacaterol
Indacaterol 150 µg once daily
Placebo
Placebo once daily
03
Endpoints
Primary
Trough Forced Expiratory Volume in One Second Change
Secondary
St. George Respiratory Questionnaire for COPD Change
Transition Dyspnea Index Change
Incidence of COPD Exacerbation
04
Results
Primary endpoints met
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