Results from a third lung function study comparing the efficacy and safety of Umeclidinium and Vilanterol ( Anoro Ellipta; UMEC/VI ), a 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 ) have been published in the Respiratory Medicine.
In this study Umeclidinium and Vilanterol 62.5/25 mcg showed a statistically significant improvement of 112mL compared with Tiotropium 18mcg ( 95% confidence interval [ C ] 81, 144, p less than 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 ) Umeclidinium and Vilanterol 62.5/25mcg showed a statistically significant improvement of 105mL, ( 95% confidence interval [ CI ] 71, 140, p less than 0.001 ) compared to Tiotropium 18 mcg.
The most commonly reported side effects for both Umeclidinium and Vilanterol and Tiotropium included headache ( 9% Umeclidinium / Vilanterol; 7% Tiotropium ), nasopharyngitis ( 6% vs 7% ), cough ( 3% vs 3% ) and back pain ( 2% vs 3% ).
The overall incidence of on-treatment adverse events was 44% in the Umeclidinium and Vilanterol group and 42% in the Tiotropium group.
The incidence of any on-treatment serious adverse event in both treatment arms was 4%.
Umeclidinium and Vilanterol 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 ).
This study was a 24-week, blinded, parallel group, multicenter study to assess the efficacy and safety of Umeclidinium and Vilanterol 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 Umeclidinium and Vilanterol 62.5/25mcg inhalation powder or Tiotropium 18mcg.
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.
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 ). ( Xagena )
Source: GSK, 2014