Tiotropium-to-Anoro Ellipta Switch Studied in COPD Trial

Approval was based on a 12-week, multi-center, randomized, blinded study
Approval was based on a 12-week, multi-center, randomized, blinded study

GlaxoSmithKline and Innovia announced new data at the American Thoracic Society (ATS) 2016 International Conference regarding the safety and efficacy of Anoro Ellipta (umeclidinium/vilanterol) in patients with moderate chronic obstructive pulmonary disease (COPD) who continued to have symptoms while on tiotropium monotherapy.

DB2116960 was a 12-week, multi-center, randomized, blinded study (n=494) that compared Anoro Ellipta with tiotropium in patients with moderate COPD who continued to experience symptoms on tiotropium. Patients were randomized 1:1 to Anoro Ellipta or tiotropium and received at least 1 dose of study medication.

Study patients who were switched from tiotropium 18mcg to Anoro Ellipta 62.5/25mcg had a statistically significant improvement of 88mL (95% CI: 45, 131; P<0.001) in lung function as measured by trough FEV1 (primary endpoint) at Week 12 vs. patients who remained on tiotropium for the study duration. 

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Also, a statistically significant improvement in lung function of 73mL (95% CI: 24, 122; P=0.004) in FEV1 at 3 hours post-dose (secondary endpoint) was seen at Week 12 for patients who were switched to Anoro Ellipta vs. patients who remained on tiotropium 18mcg for the study duration. The most commonly reported adverse events for both tiotropium and Anoro Ellipta were nasopharyngitis and headache.

Anoro Ellipta combines umeclidinium, a long-acting muscarinic antagonist (LAMA), and vilanterol, a long-acting beta-2 adrenergic agonist (LABA). It is available as a 62.5/25mcg dry powder for oral inhalation in 30-dose inhalers.

For more information call (888) 825-5249 or visit Anoro.com.

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