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news.GlaxoSmithKline announced positive results from two head-to-head studies directly comparing the efficacy and safety of Incruse Ellipta (umeclidinium) to two available bronchodilator treatments, tiotropium (study 201316) or glycopyrronium (study 201315), when used by patients with COPD.
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Results from the randomised, blinded study 201316 showed that umeclidinium 62.5mcg once daily achieved a statistically significant improvement in lung function measured by trough forced expiratory volume in one second (FEV1) at 12 weeks (P<0.001), compared to tiotropium 18mcg administered once daily.
The difference in treatment effect observed was 59ml (95% CI: 29, 88) for umeclidinium compared to tiotropium based on a per protocol analysis. For the intention to treat population, the difference observed was 53ml (95% CI: 25, 81), which was also statistically significant (P<0.001).
Results from the randomised, open-label study 201315 showed thatumeclidinium 62.5mcg once daily was non-inferior to glycopyrronium 44mcg administered once daily, also measured by trough FEV1 at 12 weeks.
The difference in treatment effect observed was 24ml (95% CI: -5, 54) for umeclidinium compared to glycopyrronium based on a per protocol analysis. For the intention to treat population, the difference observed was 33ml (95% CI: 5, 61).
In study 201316, the most commonly reported on-treatment adverse events for both umeclidinium and tiotropium were headache (6% umeclidinium; 6% tiotropium) and nasopharyngitis (5% umeclidinium; 5% tiotropium).
The overall incidence of on-treatment adverse events was 32% in the umeclidinium group and 30% in the tiotropium group. The incidence of any on-treatment serious adverse event in both treatment arms was 3%.
In study 201315, the most commonly reported on-treatment adverse events for both umeclidinium and glycopyrronium were headache (8% umeclidinium; 10% glycopyrronium) and nasopharyngitis (8% umeclidinium; 8% glycopyrronium).
The overall incidence of on-treatment adverse events was 37% in the umeclidinium group and 36% in the glycopyrronium group. The incidence of any on-treatment serious adverse event in both treatment arms was 3%.