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. 2016 Aug 18;3(4):716-728.
doi: 10.15326/jcopdf.3.4.2016.0131.

Long-Term Maintenance Bronchodilation With Indacaterol/Glycopyrrolate Versus Indacaterol in Moderate-to-Severe COPD Patients: The FLIGHT 3 Study

Gary T Ferguson  1 , Angel Fowler Taylor  2 , Chau Thach  2 , Qian Wang  3 , Agnes A Schubert-Tennigkeit  4 , Francesco Patalano  4 , Donald Banerji  2
Affiliations

Long-Term Maintenance Bronchodilation With Indacaterol/Glycopyrrolate Versus Indacaterol in Moderate-to-Severe COPD Patients: The FLIGHT 3 Study

Gary T Ferguson et al. Chronic Obstr Pulm Dis. .

Abstract

Background: The objective of the FLIGHT3 study was to evaluate the long-term safety and efficacy of indacaterol/glycopyrrolate* (IND/GLY) versus an active comparator, IND, in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) over 52 weeks. Method: FLIGHT3 was a multicenter, randomized, double-blind, parallel-group, 52-week study. Patients were randomized (1:1:1) to IND/GLY (27.5/15.6 or 27.5/31.2 µg twice daily [b.i.d.]) or IND (75 µg once daily [o.d.]), delivered via the Neohaler® device. The primary objective was to evaluate the long-term safety and tolerability of IND/GLY versus IND in terms of adverse event (AE)-reporting rates in patients with moderate-to-severe COPD over 52 weeks. The secondary objective was to evaluate the long-term efficacy of IND/GLY versus IND in terms of pre-dose trough forced expiratory volume in 1 second (FEV1) and post-dose 1-h FEV1 over 52 weeks. Results: A total of 85.2% patients completed the study treatment. The overall incidence of AEs (and SAEs) was similar between treatments. Major adverse cardiovascular events (MACE) and/or cardiovascular (CV) events were comparable between treatment groups. The rate of discontinuation of the study treatment due to AEs was lower for IND/GLY than IND. Improvements in pre-dose trough FEV1 and post-dose 1-h FEV1 were consistently superior with IND/GLY than with IND over 52 weeks, demonstrating long-term maintenance of lung function. Conclusions: IND/GLY demonstrated a favorable long-term safety and tolerability profile and provided effective bronchodilation, with maintenance of lung function over 52 weeks in patients with moderate-to-severe COPD. These data support the safety and efficacy of IND/GLY as a treatment option for COPD. Trial registration: ClinTrials.gov identifier NCT01682863 *Glycopyrrolate 15.6 µg (excluding the bromide salt) is equivalent to 12.5 µg glycopyrronium.

Keywords: chronic obstructive pulmonary disease; clinical trials; copd; long-acting beta2-agonists; long-acting muscarinic antagonist.

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Conflict of interest statement

GF is supported in part by multiple pharmaceutical clinical research projects, including grants from Novartis Pharmaceuticals, Corp. AFT, AST, FP and DB are employees of Novartis Pharmaceuticals Corp.

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