Theravance reports positive data from Anoro Ellipta’s third lung function trial in COPD

20th October 2014 (Last Updated October 20th, 2014 18:30)

Theravance has reported positive results from a third lung function trial of Anoro Ellipta (umeclidinium /vilanterol, UMEC/VI) with the LAMA tiotropium, administered in the HandiHaler inhaler, in patients with chronic obstructive pulmonary disease (COPD).

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Theravance has reported positive results from a third lung function trial of Anoro Ellipta (umeclidinium /vilanterol, UMEC/VI) with the LAMA tiotropium, administered in the HandiHaler inhaler, in patients with chronic obstructive pulmonary disease (COPD).

Anoro Ellipta is the combination long-acting muscarinic antagonist (LAMA) / long-acting beta2-adrenergic agonist (LABA).

The 24-week, blinded, parallel group, multicentre trial evaluated 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 in the trial.

At the end of the treatment period in the trial, UMEC/VI 62.5/25mcg showed a statistically significant improvement of 112mL compared with tiotropium 18mcg.

"A total of 905 patients with COPD were randomised 1:1 to UMEC/VI 62.5/25mcg inhalation powder or tiotropium 18mcg in the trial."

The most commonly reported side effects for both UMEC/VI and tiotropium included headache, nasopharyngitis, cough and back pain.

GSK Global Respiratory Franchise senior vice-president and head Darrell Baker 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."

Theravance president and chief executive officer Michael Aguiar 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."

Previously, UMEC/VI showed 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).


Image: A chest X-ray demonstrating severe COPD. Photo: courtesy of James Heilman, MD.