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FLIGHT 2: QVA149 in Moderate to Severe COPD
NCT01712516Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2012
- Primary completion
- Feb 2014
- Countries
- 9
- Sponsor
- Novartis
- Modality
- Small Molecules
- Conditions
- chronic obstructive pulmonary disease (COPD)
01
Overview
Phase 3, randomised, double-blind trial of indacaterol + glycopyrronium in chronic obstructive pulmonary disease (COPD) (4 arms), sponsored by Novartis. Primary endpoint: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours) at 12 weeks. Started Dec 2012; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
QVA149
Indacaterol 27.5 mcg / Glycopyrronium 12.5 mcg b.i.d.
QAB149
Indacaterol 27.5 mcg b.i.d.
NVA237
Glycopyrronium 12.5 mcg b.i.d.
Placebo
Placebo b.i.d.
03
Who it enrols
Patients with moderate to severe COPD, >= 40 years old, smoking history >= 10 pack years.
04
Endpoints
Primary
Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours)
Secondary
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score
Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score
Change From Baseline in Trough FEV1
Transitional Dyspnea Index (TDI) Focal Score
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication
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