LONDON (Alliance News) - GlaxoSmithKline PLC and US biotechnology company Theravance Inc said Wednesday that it has commenced the global phase III study, IMPACT, into the efficacy and safety of a combination of treatments for patients with chronic obstructive pulmonary disease.
The companies said that IMPACT will evaluate the efficacy and safety of a once-daily 'closed' triple combination of fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist, and vilanterol, a long-acting beta2-adrenergic agonist, known as FF/UMEC/VI, in patients with the disease.
Chronic obstructive pulmonary disease 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.
The study on approximately 10,000 patients will assess whether a combination of the treatments, delivered through Glaxo's Ellipta inhaler, can reduce the annual rate of moderate and severe exacerbations compared with two approved once daily chronic obstructive pulmonary disease treatments, Relvar/Breo Ellipta (FF/VI), which is an ICS/LABA combination, and Anoro Ellipta (UMEC/VI), which is a LAMA/LABA combination.
Glaxo said the IMPACT - InforMing the PAthway of COPD Treatment - study is a double-blind, three-arm, parallel group study enrolling a total of 10,000 patients across 38 countries. Eligible patients will be randomised to receive either FF/UMEC/VI 100/62.5/25mcg, FF/VI 100/25mcg or UMEC/VI 62.5/25mcg once-daily for a period of 52 weeks.
"We know from the scientific literature and prescribing data that there are already COPD patients who receive three medicines in different inhalers, for whom a once-daily treatment in a single 'closed' device could be valuable. The IMPACT study will be important in advancing our understanding of how the combination of FF/UMEC/VI could be used in this setting when compared to dual combination therapy options," said Head of GSK's Respiratory Therapy Area Unit, R&D, Dave Allen.
Shares in GSK were trading 0.75% higher at 1,555.00 pence per share shortly after the market open Wednesday.
By Alice Attwood; aliceattwood@alliancenews.com; @AliceAtAlliance
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