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Obstructive Lung Diseases |

QVA149, Twice Daily, Is Well Tolerated in Patients With Moderate-to-Severe COPD and Has a Safety Profile Similar to Placebo: FLIGHT1 and FLIGHT2 Pooled Analysis in the Subgroup of Patients From the USA

Tim Ayers, MD; Robert Fogel, MD; Donald Banerji, MD; Samopriyo Maitra; Agnes Annette Schubert-Tennigkeit
Author and Funding Information

Novartis Pharmaceuticals Corporation, East Hanover, NJ; Medical Communications, Novartis Healthcare Pvt Ltd, Hyderabad, New Jersey, India; Novartis Pharma AG, Basel, Switzerland


Chest. 2015;148(4_MeetingAbstracts):725A. doi:10.1378/chest.2279524
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Abstract

SESSION TITLE: COPD Posters V

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM

PURPOSE: Current guidelines recommend the addition of a second bronchodilator class to the existing bronchodilator regimen for the effective management of symptoms in moderate-to-severe chronic obstructive pulmonary disease (COPD). QVA149 (IND/GLY) is a dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist, indacaterol (IND), and the long-acting muscarinic antagonist, glycopyrronium (GLY), for the management of symptoms in COPD patients. FLIGHT1 and FLIGHT2 studies assessed the efficacy and safety of IND/GLY 27.5 μg/12.5 μg twice daily in patients with moderate-to-severe COPD.

METHODS: FLIGHT1 and FLIGHT2 were replicate, 12-week, multicenter, randomized, double-blind, parallel-group, placebo- and active-controlled studies, designed to assess the efficacy, safety, and tolerability of twice-daily IND/GLY 27.5 μg/12.5 μg versus its monocomponents, IND 27.5 μg and GLY 12.5 μg, and placebo in patients with moderate-to-severe COPD. Here, we report the safety outcomes such as incidence of adverse events (AEs), serious adverse events (SAEs), major adverse cardiac events (MACE) and deaths, with IND/GLY compared with placebo and the monocomponents, IND and GLY, in the subgroup of patients from the USA.

RESULTS: A total of 810 patients enrolled in the USA study centers were included in this pooled analysis (IND/GLY, n=275; IND, n=256; placebo, n=279). The incidence of AEs with IND/GLY (50.18%) was similar to that of placebo (49.82%). The most frequently reported AE in all treatment groups was worsening of COPD symptoms, and its incidence was lowest with IND/GLY (11.64%) compared to IND (13.28%) and placebo (19.00%). The incidence of SAEs (IND/GLY, 4.73%; IND, 3.52%; placebo, 3.58%) and incidence of adjudicated MACE (IND/GLY, 0.73%, IND, 0.39%, placebo, 0.36%) was similar between the treatments. There were two cardiovascular deaths during these studies, one in the IND treatment arm and the other in the placebo arm and neither was suspected to be related to the study treatment.

CONCLUSIONS: IND/GLY 27.5 μg/12.5 μg, twice daily, is well tolerated in patients with moderate-to-severe COPD and has a safety profile that is similar to placebo and indacaterol 27.5 μg.

CLINICAL IMPLICATIONS: IND/GLY, twice daily, is a safe maintenance treatment option for management of symptoms in patients with moderate-to-severe COPD.

DISCLOSURE: Tim Ayers: Employee: Employee of the study sponsor, Novartis, and no other conflicts. Samopriyo Maitra: Employee: Employee of the study sponsor, Novartis, and no other conflicts Agnes Annette Schubert-Tennigkeit: Employee: Employee of the study sponsor, Novartis, and no other conflicts. Robert Fogel: 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


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