Efficacy of Indacaterol/Glycopyrrolate in Patients with COPD by Airway Reversibility at Baseline: A Pooled Analysis of the FLIGHT1 and FLIGHT2 12-Week Studies

Abstract

Bronchodilator reversibility occurs in patients with COPD. Pooled analysis of two 12-week, placebo-controlled randomised studies (FLIGHT1 [NCT01727141]; FLIGHT2 [NCT01712516]) assessed the effect of bronchodilator reversibility on lung function, patient-reported outcomes, and safety in 2,043 patients with moderate-to-severe COPD treated with indacaterol/glycopyrrolate (IND/GLY) 27.5/15.6 µg twice daily. Reversibility was defined as post-bronchodilator increase in forced expiratory volume in one second (FEV₁) of ≥12% and ≥0.200 L. Overall, mean reversibility (mean post-bronchodilator FEV₁ increase) was 22.8%, and 54.5% of patients met reversibility criteria. IND/GLY resulted in significant (p < 0.05) placebo-adjusted improvements from baseline at Week 12 in reversible and non-reversible patients in FEV₁ area under the curve from 0 to 12 hours (0.308 L and 0.170 L, respectively), trough FEV₁ (0.260 L and 0.174 L), St. George’s Respiratory Questionnaire total score (−6.3 and –3.5), COPD Assessment Test total score (−2.3 and –1.2), daily rescue medication use (−1.52 and −0.79), and daily total symptom score (−0.86 and –0.63); Transition Dyspnoea Index focal score also showed improvements (1.93 and 1.29) at Week 12, irrespective of reversibility status. Improvements in lung function and rescue medication use were significantly (p < 0.05) greater in IND/GLY patients in the reversible subgroup compared with the non-reversible subgroup. The safety profile was similar across treatment groups and reversibility subgroups. Overall, treatment with IND/GLY led to significant improvements in lung function and PROs in patients with moderate-to-severe COPD, regardless of reversibility status, with greater improvements in the reversible subgroup. Safety profile was not affected by reversibility status.

Keywords:

• Bronchodilator
• COPD
• indacaterol/glycopyrrolate
• reversibility

Acknowledgments

Medical writing support in the preparation of this article was provided by Linda Townsend, PhD, of FireKite, an Ashfield company, part of UDG Healthcare plc, and was funded by Sunovion Pharmaceuticals Inc.

Declaration of interest

JAO has served on advisory boards for Sunovion Pharmaceuticals Inc., AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Mylan, and Theravance.

S Sharma, TG, AB, BP, AO-G, and S Sanjar are employees of Sunovion Pharmaceuticals Inc.

Data sharing statement

Sunovion Pharmaceuticals Inc. is part of a clinical trial data sharing consortium that facilitates access for qualified researchers to selected anonymized clinical trial data. For up-to-date information on data availability please visit https://www.clinicalstudydatarequest.com/Study-Sponsors.aspx and click on ‘Sunovion’.

Additional information

Funding

This post-hoc analysis was funded by Sunovion Pharmaceuticals Inc. The FLIGHT1 and FLIGHT2 studies were sponsored by Novartis Pharma AG.