SESSION TITLE: COPD Posters V
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: Dyspnea is a critical symptom of COPD and a major cause of the disease-associated disability. Dual bronchodilation therapy is recommended by the GOLD 2015 strategy, if symptoms are not adequately managed by a single bronchodilator. QVA149 (110/50 µg) is an inhaled fixed-dose combination of indacaterol (IND) and glycopyrronium (GLY), approved in over 50 countries including EU, Japan, Canada, Mexico, Australia and Switzerland for the maintenance treatment of COPD. Here, we report the effect of QVA149 (IND/GLY) on dyspnea versus its monocomponents and placebo from the pooled analysis of the FLIGHT1 and FLIGHT2 studies.
METHODS: FLIGHT1 and FLIGHT2 were replicate, 12-week, multicenter, double-blind studies that randomized (1:1:1:1) patients with moderate-to-severe COPD to IND/GLY (27.5/12.5 µg b.i.d.), IND (27.5 µg b.i.d.), GLY (12.5 µg b.i.d.) and placebo. Data on Transition Dyspnea Index (TDI) total score at Week 12 were pooled from these studies. The percentage of patients that achieved minimal clinically important difference (MCID) in TDI total score was also reported.
RESULTS: Data from 1873 patients were pooled and analyzed (IND/GLY, n=479; IND, n=468; GLY, n=478 and placebo, n=448). IND/GLY demonstrated statistically significant and clinically meaningful (MCID ≥1 unit) improvement in TDI total score compared with placebo at Week 12 (least squares mean treatment difference [LSMTD]: 1.64; p<0.001). Improvement in TDI total score was also significantly greater with IND/GLY versus IND (LSMTD: 0.78; p<0.001) and GLY (LSMTD: 0.73; p<0.001). The percentage of patients that achieved MCID in TDI total score was higher with IND/GLY (64.9%) versus placebo (42.2%; odds-ratio [OR]: 2.80; p<0.001), IND (58.3%; OR: 1.51; p=0.003) and GLY (52.9%; OR: 1.58; p=0.001).
CONCLUSIONS: In this pooled analysis, IND/GLY provided statistically significant improvement in dyspnea, as measured by TDI total score versus placebo and its monocomponents in patients with moderate-to-severe COPD. Also, the proportion of patients achieving MCID was significantly higher with IND/GLY compared with placebo and monocomponents.
CLINICAL IMPLICATIONS: These findings support the use of IND/GLY in relieving dyspnea in patients with moderate‑to‑severe COPD.
DISCLOSURE: Donald Mahler: Consultant fee, speaker bureau, advisory committee, etc.: Advisory Boards: BI; GSK;Novartis; Sunovion. Royalties: CRC press-Dyspnea 3rd edition; MAPI-use of BDI/TDI; Speaker's bureau:GSK Michael Larbig: Employee: Employee of the study sponsor, Novartis and no other conflicts Samopriyo Maitra: Employee: Employee of the study sponsor, Novartis and no other conflicts Francesco Patalano: Employee: Employee of the study sponsor, Novartis and no other conflicts Donald Banerji: Employee: Employee of the study sponsor, Novartis and no other conflicts
No Product/Research Disclosure Information