Date: 2014-03-14
Type of information:
phase: 3
Announcement: results
Company: GSK (UK) Theravance (USA)
Product: Anoro® Ellipta®
Action mechanism: Anoro® Ellipta® is the first once-daily anticholinergic/ LABA combination product approved in the US for the long-term once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma. Anoro contains 62.5 mcg umeclidinium, an anticholinergic, and 25 mcg vilanterol, a LABA , in a single inhaler, the Ellipta.
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial details: All three studies (116134, 114930 and 114951) were 12-week multicentre, randomised, double-blind, double-dummy, parallel group studies. Approximately 2100 patients across the three studies, with post-salbutamol FEV1 of ? 30% and ? 70% and no history of moderate to severe COPD exacerbations in the last 12 months, were enrolled into the studies. Eligible patients were randomised to receive either UMEC /VI (62.5/25mcg) administered as a once-daily inhalation and placebo administered twice-daily, or FSC (500/50 mcg in study 116134 and 250/50mcg in studies 114930 and 114951) administered as a twice-daily inhalation and placebo administered once-daily. UMEC /VI was administered in the dry powder inhaler (DPI), Ellipta and FSC in the multi-dose powdered inhaler, Diskus .
Latest
news: * On March 14, 2014, GSK and Theravance have announced positive results from three phase III studies. Two studies comparing the efficacy and safety of the combination anticholinergic / long-acting beta2-adrenergic agonist, Anoro™ Ellipta™ (umeclidinium/vilanterol, \' UMEC /VI\') with inhaled corticosteroid / long-acting beta2-adrenergic agonist combination, Advair® Diskus ® (fluticasone propionate/salmeterol \'FSC 250/50\') and the third comparing the efficacy and safety of Anoro Ellipta with Seretide® Diskus® \'FSC 500/50\' in patients with chronic obstructive pulmonary disease (COPD) and no history of moderate to severe COPD exacerbations in the last year. In each of the studies UMEC /VI achieved a statistically significant improvement in lung function, measured as weighted mean forced expiratory volume in one second (wm FEV1) over 0-24 hours at the end of the 12 week study (day 84), compared to either dose of FSC.
Studies results:
116134: For the pre-specified primary endpoint of 0-24 h wm FEV1 at the end of the treatment period (day 84), UMEC /VI 62.5/25mcg showed a statistically significant improvement of 80mL compared with FSC 500/50mcg (95% CI 46, 113; p < 0.001). In this study the most frequently reported (greater than or equal to 3% in any treatment group) adverse events were headache (9% UMEC /VI and 7% FSC), nasopharyngitis (3% UMEC /VI and 3% FSC), back pain (2% UMEC /VI and 3% FSC) and dysphonia ( < 1% UMEC /VI and 3% FSC). The incidence of any cardiovascular adverse events of special interest was similar in the two treatment groups (2% UMEC /VI and < 1 % FSC). There was no incidence of pneumonia in the UMEC /VI group and < 1% in the FSC group. The incidence of lower respiratory tract infections excluding pneumonia was < 1% in the UMEC /VI group and none in the FSC group. The incidence of on-treatment non-fatal serious adverse events (SAEs) was similar across the treatment groups (2% in the UMEC /VI group and < 1% in the FSC group). There was one patient with an on-treatment fatal SAE in the UMEC /VI treatment group and none in the FSC group.
114930: For the pre-specified primary endpoint of 0-24 h wm FEV1 at the end of the treatment period (day 84), UMEC /VI 62.5/25mcg showed a statistically significant improvement of 74mL compared with FSC 250/50mcg (95% CI 38, 110; p < 0.001). In this study the most frequently reported (greater than or equal to 3% in any treatment group) adverse events were headache (7% UMEC /VI and 5% FSC) and nasopharyngitis (5% UMEC /VI and 2% FSC). The incidence of any cardiovascular adverse events of special interest was similar across the treatment groups (1% UMEC /VI and 2% FSC). The incidence of pneumonia was similar across both treatment groups ( < 1% UMEC /VI and 1% FSC). The incidence of lower respiratory tract infections excluding pneumonia was none in the UMEC /VI group and < 1% FSC group. The incidence of on-treatment non-fatal serious adverse events (SAEs) was 2% in the UMEC /VI group and 3% in the FSC group. There was one patient with an on-treatment fatal SAE in the FSC group and none in the UMEC /VI group.
114951: For the pre-specified primary endpoint of 0-24 h wm FEV1 at the end of the treatment period (day 84), UMEC /VI 62.5/25mcg showed a statistically significant improvement of 101mL compared with FSC 250/50mcg (95% CI 63, 139; p < 0.001). In this study, the most frequently reported (greater than or equal to 3% in any treatment group) adverse events were headache (7% UMEC /VI and 7% FSC) and nasopharyngitis (4% UMEC /VI and 2% FSC). The incidence of any cardiovascular events of special interest was 3% UMEC /VI and 2% FSC. The incidence of pneumonia was < 1% UMEC /VI and 1% FSC. The incidence of lower respiratory tract infections excluding pneumonia was < 1% UMEC /VI and < 1% FSC. The incidence of on-treatment non-fatal serious adverse events (SAEs) was 3% UMEC /VI group and 3% FSC group. There were 2 patients with on treatment fatal SAEs in the UMEC /VI group and 3 patients with on treatment fatal SAEs in the FSC group.The full results of these studies will be posted onto clinicaltrials.gov and presented at a future scientific meeting.
Umeclidinium/vilanterol is only approved for use in the US and Canada . It is not approved anywhere else in the world.
