FLIGHT1 and FLIGHT2 : Efficacy and Safety of QVA149 (Indacaterol/Glycopyrrolate) versus Its Monocomponents and Placebo in Patients with Chronic Obstructive Pulmonary Disease
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).
| Errataetall: |
CommentIn: Am J Respir Crit Care Med. 2015 Nov 1;192(9):1028-30. - PMID 26517413 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2015 |
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| Erschienen: |
2015 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:192 |
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| Enthalten in: |
American journal of respiratory and critical care medicine - 192(2015), 9 vom: 01. Nov., Seite 1068-79 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Mahler, Donald A [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 02.05.2016 Date Revised 09.04.2022 published: Print ClinicalTrials.gov: NCT01727141 CommentIn: Am J Respir Crit Care Med. 2015 Nov 1;192(9):1028-30. - PMID 26517413 Citation Status MEDLINE |
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| doi: |
10.1164/rccm.201505-1048OC |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM250905825 |
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| 100 | 1 | |a Mahler, Donald A |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a FLIGHT1 and FLIGHT2 |b Efficacy and Safety of QVA149 (Indacaterol/Glycopyrrolate) versus Its Monocomponents and Placebo in Patients with Chronic Obstructive Pulmonary Disease |
| 264 | 1 | |c 2015 | |
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| 500 | |a Date Completed 02.05.2016 | ||
| 500 | |a Date Revised 09.04.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT01727141 | ||
| 500 | |a CommentIn: Am J Respir Crit Care Med. 2015 Nov 1;192(9):1028-30. - PMID 26517413 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Ayers, Tim |e verfasserin |4 aut | |
| 700 | 1 | |a FowlerTaylor, Angel |e verfasserin |4 aut | |
| 700 | 1 | |a Maitra, Samopriyo |e verfasserin |4 aut | |
| 700 | 1 | |a Thach, Chau |e verfasserin |4 aut | |
| 700 | 1 | |a Lloyd, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a Patalano, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a Banerji, Donald |e verfasserin |4 aut | |
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