GSK starts asthma treatment study

GlaxoSmithKline and Innoviva have announced the start of a phase III study investigating the effects of once-daily closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) when compared to therapy with the once-daily dual combination therapy, Relvar/Breo (FF/VI), as a treatment for patients with asthma.

The closed triple combination therapy comprises three medicines: fluticasone furoate, an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist (LAMA) and vilanterol, a long-acting beta2-adrenergic agonist (LABA), delivered once-daily in GSK’s Ellipta dry powder inhaler. In the phase III study, termed CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler), the primary endpoint is the change from baseline in trough Forced Expiratory volume in 1 second (FEV1) at 24 weeks of treatment and the key secondary endpoint is the annualised rate of moderate/severe asthma exacerbations. Other secondary endpoints are assessing health-related quality of life and symptom control.

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