GlaxoSmithKline and Theravance have announced the beginning of the FULFIL (Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy) Phase 3 study of a fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI in patients with COPD. The randomized double-blind study is expected to enroll approximately 1,800 patients. An earlier Phase 3 study of the triple combination, called IMPACT, began in July 2014.
The FULFIL study will compare FF/UMEC/VI (100mcg/62.5mcg/25mcg) delivered by the Ellipta inhaler to budesonide/formoterol delivered by the Turbuhaler DPI (Symbicort). The primary endpoints are quality of life and lung function after 24 weeks. The study will also evaluate the inhaler’s effect on the rate of exacerbations and its safety, particularly the risk of pneumonia and cardiovascular effects.
Head of GSK Respiratory Therapy Area Unit, R&D Dave Allen said, “Triple combination therapy is already a reality for one in three patients with COPD and is often dispensed in different inhalers with differing doses. By providing all three medicine components in a single inhaler we hope to offer more convenient dosing to patients, reduce the risk of exacerbation compared to dual therapy and, as a result, contribute to the improved management of their disease.
Theravance CEO Michael W. Aguiar commented, “With FULFIL, we hope to demonstrate that a once-daily triple combination can reduce exacerbations in patients with COPD and deliver meaningful improvements in lung function and health related quality of life. If successful, a once-daily triple combination would be an important addition to our portfolio of combination respiratory products partnered with GSK including Relvar/Breo Ellipta and Anoro Ellipta.”
Read the GSK/Theravance press release.
