Long-Term Maintenance Bronchodilation With Indacaterol/Glycopyrrolate Versus Indacaterol in Moderate-to-Severe COPD...

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.