Respiratory Medicine 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 per cent 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 per cent 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 per cent UMEC/VI; 7 per cent tiotropium), nasopharyngitis (6 per cent UMEC/VI; 7 per cent tiotropium), cough (3 per cent UMEC/VI; 3 per cent tiotropium) and back pain (2 per cent UMEC/VI; 3 per cent tiotropium). The overall incidence of on-treatment adverse events was 44 per cent in the UMEC/VI group and 42 per cent in the tiotropium group.  The incidence of any on-treatment serious adverse event in both treatment arms was 4 per cent.

Darrell Baker, SVP and Head, Global Respiratory Franchise, GSK said: “We are pleased to announce the publication of these important data comparing Anoro Ellipta with tiotropium. These results support the lung function benefit of Anoro Ellipta in the treatment of appropriate patients with COPD. We hope the publication will inform physicians as they consider which treatment option is best to meet their individual patient’s needs.”

Michael W. Aguiar, president and chief executive officer of Theravance, said: “We believe the results from this positive study will provide physicians with additional useful data regarding the potential benefits of Anoro Ellipta as a treatment option for appropriate patients with COPD.”

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.

This study was a 24-week, blinded, parallel group, multicentre 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 randomised 1:1 to UMEC/VI 62.5/25mcg inhalation powder or tiotropium 18mcg.

COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing. COPD is thought to affect 4-10 per cent of the adult population in Europe.

Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.

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).