GlaxoSmithKline (GSK) and Theravance have initiated a Phase III trial of a combination treatment of the inhaled corticosteroid (ICS), fluticasone furoate and long-acting beta2agonist (LABA), vilanterol (FF/VI) in patients with chronic obstructive pulmonary disease (COPD).
The trial is designed to assess the contribution of the ICS component on lung function, in COPD patients.
According to the company, positive results from the Phase III trial will support a potential filing of FF/VI for the treatment of patients with COPD in Japan.
The 12 week, multicentre, randomised, double-blind, parallel-group trial will evaluate the efficacy and safety of FF/VI 100/25mcg once daily compared with VI 25mcg once daily, administered via the Ellipta inhaler.
A total of 1,580 patients are expected to be enrolled in the trial from across 250 centres worldwide, including around 350 patients from centres in Japan.
All patients enrolled in the trial will have a history of COPD with at least one exacerbation in the year prior to screening.
The FF/VI Phase III clinical development programme in COPD patients included data from six trials carried out in over 6,000 COPD patients.
According to GSK, specific Japanese patient efficacy data was only available from two six-month efficacy trials, when the contribution of FF 100mcg to the combination, on lung function, did not achieve statistical significance.
The company chose to withdraw the COPD file in Japan while designing an additional study, as there was insufficient data to support the efficacy of the combination and its components in this specific patient group.
In September 2013, FF/VI strengths of 100/25mcg and 200/25mcg were licensed by the Japanese Ministry of Health Labour and Welfare for the treatment of asthma under the trade name Relvar Ellipta.
FF/VI is not currently licensed in Japan for the treatment of patients with COPD.
The combination drug is contraindicated in patients with hypersensitivity to fluticasone furoate, vilanterol, or any of the excipients and in patients with infections or deep mycosis against which there is no effective anti-bacterial agent.
In three global Phase III clinical trials, adverse reactions including laboratory abnormalities were reported in 100 of a total of 1,407 patients (including 61 Japanese patients) treated with FF/VI.
In these trials, the common adverse reactions were dysphonia and oral candidiasis reported in 19 (1.4%) and 12 (0.9%) patients, respectively.
Out of 61 Japanese patients, adverse reactions including laboratory abnormalities were reported in seven.
Image: Lung bulla as seen on CXR in a person with severe COPD associated with anti 1 antitrypsin deficiency. Photo: courtesy of James Heilman, MD.