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- Title
FLIGHT1 and FLIGHT2: Efficacy and Safety of QVA149 (Indacaterol/Glycopyrrolate) versus Its Monocomponents and Placebo in Patients with Chronic Obstructive Pulmonary Disease.
- Authors
Mahler, Donald A.; Kerwin, Edward; Ayers, Tim; Taylor, Angel Fowler; Maitra, Samopriyo; Thach, Chau; Lloyd, Mark; Patalano, Francesco; Banerji, Donald; FowlerTaylor, Angel
- Abstract
<bold>Rationale: </bold>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.<bold>Objectives: </bold>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.<bold>Methods: </bold>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.<bold>Measurements and Main Results: </bold>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.<bold>Conclusions: </bold>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).
- Subjects
HYDROCARBONS; BRONCHODILATOR agents; MUSCARINIC antagonists; QUINOLONE antibacterial agents; COMBINATION drug therapy; COMPARATIVE studies; OBSTRUCTIVE lung diseases; RESEARCH methodology; MEDICAL cooperation; QUESTIONNAIRES; RESEARCH; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; BLIND experiment; SEVERITY of illness index; GLYCOPYRROLATE; THERAPEUTICS
- Publication
American Journal of Respiratory & Critical Care Medicine, 2015, Vol 192, Issue 9, p1068
- ISSN
1073-449X
- Publication type
journal article
- DOI
10.1164/rccm.201505-1048OC