Sunovion announced that new Phase 3 study data showed Utibron Neohaler(indacaterol/glycopyrrolate) inhalation powder improved lung function, health-related quality of life (HRQL), dyspnea, and nighttime symptoms vs. placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). Findings from the FLIGHT1, FLIGHT2, and FLIGHT3 studies were presented at the 2017 American Thoracic Society International Conference (ATS 2017). 

A pooled analysis of FLIGHT1 and FLIGHT2 showed that Utibron Neohaler use led to significant and sustained improvement in lung function vs. placebo, as measured by FEV1. Treatment differences ranged from 0.159–0.179L on Day 1 and 0.223–0.281L at Week 12 (all P<0.001). 

Findings from a pooled analysis of HRQL data from FLIGHT1 and FLIGHT2 showed that Utibron Neohaler use in moderate-to-severe COPD led to statistically and clinically significant improvements in disease specific HRQL, as measured by SGRQ  as well as dyspnea, as measured by TDI vs. placebo after 12 weeks of treatment. The clinical improvements were seen for all patients regardless of age, sex, disease severity, smoking status or baseline use of drugs.  

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Two additional pooled analyses of FLIGHT1 and FLIGHT2 showed that treatment with Utibron Neohaler led to significant reduction in total nighttime COPD symptoms score vs. placebo over 12 weeks. Also, there was a significant reduction in the use of rescue medications at night (treatment difference –0.50; P<0.001) and a significant increase in the number of nights with no awakenings (treatment difference 7.7; P<0.001), when compared to placebo after 12 weeks.

Thomas H. Goodin, PhD, Senior Director, Clinical Development at Sunovion, added, “The data presented at ATS indicate that Utibron Neohaler was associated with statistically significant and clinically important improvements in lung function as well as a reduction in the number of sleep disturbances and in the use of rescue medication, which may have a positive impact on patients’ quality of life.”

Utibron Neohaler combines indacaterol, a long-acting beta-2 agonist (LABA), and glycopyrrolate, a long-acting muscarinic antagonist (LAMA). It is available as 27.5mcg/15.6mcg strength powder in 6- and 60-count blister packs for use with a Neohaler device.

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