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Am J Respir Crit Care Med. 2015 Nov 1;192(9):1068-79. doi: 10.1164/rccm.201505-1048OC.

FLIGHT1 and FLIGHT2: Efficacy and Safety of QVA149 (Indacaterol/Glycopyrrolate) versus Its Monocomponents and Placebo in Patients with Chronic Obstructive Pulmonary Disease.

Author information

1
1 Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.
2
2 Valley Regional Hospital, Claremont, New Hampshire.
3
3 Clinical Research Institute of Southern Oregon, Medford, Oregon.
4
4 Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
5
5 Novartis Healthcare Pvt. Ltd., Hyderabad, India; and.
6
6 Novartis Pharma AG, Basel, Switzerland.

Abstract

RATIONALE:

Current Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy recommends the combination of two long-acting bronchodilators of different pharmacologic classes for the management of chronic obstructive pulmonary disease (COPD) if symptoms are not adequately controlled by a single bronchodilator.

OBJECTIVES:

The FLIGHT1 and FLIGHT2 studies evaluated the efficacy and safety of QVA149 (indacaterol/glycopyrrolate), a fixed-dose combination of a long-acting β2-agonist (indacaterol) and a long-acting muscarinic antagonist (glycopyrrolate), compared with its monocomponents and placebo in patients with moderate-to-severe COPD.

METHODS:

FLIGHT1 and FLIGHT2 were 12-week, identical, multicenter, randomized, double-blind, parallel-group, placebo- and active-controlled studies. Patients were randomized (1:1:1:1) to indacaterol/glycopyrrolate (27.5/15.6 μg twice daily), indacaterol (27.5 μg twice daily), glycopyrrolate (15.6 μg twice daily), or placebo, all delivered via the Neohaler device. The primary objective was to demonstrate the superiority of indacaterol/glycopyrrolate versus its monocomponents for standardized area under the curve from 0-12 hours for FEV1 at Week 12. Secondary objectives included St. George's Respiratory Questionnaire total score and transition dyspnea index total score and reduction in daily rescue medication use with indacaterol/glycopyrrolate versus placebo.

MEASUREMENTS AND MAIN RESULTS:

In total, 2,038 patients were included in the pooled analysis. Indacaterol/glycopyrrolate was statistically superior in terms of FEV1 area under the curve from 0-12 hours compared with its monocomponents (P < 0.001). Statistically and clinically meaningful improvements in St. George's Respiratory Questionnaire total score, transition dyspnea index total score, and reduction in rescue medication use were observed with indacaterol/glycopyrrolate compared with placebo (P < 0.001). The safety profile was comparable across the treatment groups.

CONCLUSIONS:

Indacaterol/glycopyrrolate twice daily can be an alternative treatment option for the management of symptomatic patients with moderate-to-severe COPD. Clinical trial registered with www.clinicaltrials.gov (NCT 01727141 and NCT 0171251).

KEYWORDS:

COPD; clinical trial; fixed-dose combination; long-acting muscarinic antagonist; long-acting β2-agonists

PMID:
26177074
DOI:
10.1164/rccm.201505-1048OC
[Indexed for MEDLINE]

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