GSK’s Triple-COPD Trial a Success
By Tamer Abouras
From Digital Look, some exciting — and relieving news — for GlaxoSmithKline.
European and U.S. regulatory submissions are likely to be completed the end of 2016 based on the data from this Phase III clinical test by GSK and its regular respiratory project partner, Innoviva.
The study showed the combination of three COPD medicines delivered meaningful improvements in lung function and health-related quality of life compared to the dual therapy of budesonide/formoterol.
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Glaxo and Innoviva were testing their once-daily “closed” triple combination therapy of fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta agonist to treat patients with COPD in the 24-week “FULFIL” trial, standing for “lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy.”
The study met its two co-primary endpoints, demonstrating statistically significant improvements compared with a twice-daily dose from a Symbicort Turbohaler in both lung function as measured by the “trough FEV1” measure of lung capability and health-related quality of life as measured by the St. George's Respiratory Questionnaire at the end of the study period.
Safety of the treatment was at the end of the trial and the 52-week extension was consistent with the individual medicines and their combinations, with the most common adverse events being nasopharyngitis, headache and COPD worsening.
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"Triple combination therapy is already a reality for many patients with COPD and is dispensed in multiple inhalers," said GSK's head of respiratory R&D, Dave Allen. "By combining three medicines in a single inhaler we can offer a convenient, once-daily dosing option to patients while improving their symptoms."
NYSE-listed Innoviva has partnered with GSK on combination respiratory products including Relvar/Breo, Ellipta and Anoro Ellipta.