Date: 2014-10-17
Type of information: Results
phase:
Announcement: results
Company: GSK (UK) Theravance (USA - CA)
Product: Anoro® Ellipta® (umeclidinium /vilanterol)
Action
mechanism: Anoro® Ellipta® is a combination long-acting muscarinic antagonist (LAMA) (also known as an anticholinergic) / long-acting beta2-adrenergic agonist (LABA). In the US, Anoro Ellipta is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma. The FDA-approved strength is umeclidinium/vilanterol 62.5/25mcg. In Europe, Anoro is indicated as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). The approved strength in Europe is UMEC/VI 55mcg/22 mcg (delivered dose, equivalent to 62.5mcg/25mcg pre-dispensed dose).
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial
details: This study was a 24-week, blinded, parallel group, multicenter study to assess the efficacy and safety of UMEC/VI 62.5/25mcg inhalation powder administered once-daily in the dry powder inhaler, Ellipta®, compared to tiotropium 18mcg administered once-daily in the HandiHaler® inhaler. A total of 905 patients with COPD were randomized 1:1 to UMEC/VI 62.5/25mcg inhalation powder or tiotropium 18mcg.
Latest
news: * On October 17, 2014, Theravance has published positive results from a third lung function study comparing the efficacy and safety of Anoro® Ellipta® (umeclidinium /vilanterol, \'UMEC/VI\'), the combination long-acting muscarinic antagonist (LAMA) / long-acting beta2-adrenergic agonist (LABA), with the LAMA tiotropium, administered in the HandiHaler® inhaler, in patients with chronic obstructive pulmonary disease (COPD).
In this study UMEC/VI 62.5/25 mcg showed a statistically significant improvement of 112mL compared with tiotropium 18mcg (95% confidence interval (CI) 81, 144, p < 0.001) for the primary endpoint measurement of lung function using trough forced expiratory volume in one second (FEV1) at the end of the treatment period (day 169).
For the secondary endpoint measurement of lung function using weighted mean FEV1 0 - 6 hour, at the end of the treatment period (day 168) UMEC/VI 62.5/25mcg showed a statistically significant improvement of 105mL, (95% confidence interval (CI) 71, 140, p < 0.001) compared to tiotropium 18 mcg.
The most commonly reported side effects for both UMEC/VI and tiotropium included headache (9% UMEC/VI; 7% tiotropium), nasopharyngitis (6% UMEC/VI; 7% tiotropium), cough (3% UMEC/VI; 3% tiotropium) and back pain (2% UMEC/VI; 3% tiotropium). The overall incidence of on-treatment adverse events was 44% in the UMEC/VI group and 42% in the tiotropium group. The incidence of any on-treatment serious adverse event in both treatment arms was 4%.
UMEC/VI previously demonstrated statistically significant improvements in trough FEV1 compared with tiotropium in an earlier six-month active-comparator study (DB2113360), and numerically greater (although not statistically significant) improvements from tiotropium in another (DB2113374). These data were previously announced in July 2012.
