UK pharma major GlaxoSmithKline (LSE: GSK) has announced positive data comparing its Incruse Ellipta (umeclidinium) to two available bronchodilator treatments, tiotropium and glycopyrronium in chronic obstructive pulmonary disease (COPD).
Study 201316 looked at umeclidinium 62.5mcg administered once daily versus tiotropium 18mcg in terms of trough forced expiratory volume in one second at 12 weeks. The difference in treatment effect observed was 59 ml for umeclidinium compared to tiotropium based on a per protocol analysis. In the intent to treat population, the difference observed was 53 ml, also statistically significant. The most commonly reported adverse events were headache, which occurred in 6% of umeclidinium and 6% of tiotropium patients. Overall, the incidence of on-treatment adverse events was 32% in the umeclidinium group and 30% in the tiotropium group. Serious adverse events occurred in 3% of patients.
Study 201315 showed non-inferiority in umeclidinium 62.5mcg daily compared to glycopyrronium 44 mcg administered once daily. The difference in treatment effect observed was 24 ml for umeclidinium compared to glycopyrronium, and among the intent to treat population, the difference observed was 33 ml.
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