Conditions: Asthma
Keywords: respiratory adult asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4233
Healthy volunteers: no

Brief summary:
This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma. This is a Phase III multi-centre, randomised open label study. Subjects who meet the eligibility criteria are randomised and will enter a 12 month treatment period.

Detailed description:
This is a Phase III multi-centre, randomised open label study performed in subjects followed in primary care who have a diagnosis of and receive regular treatment for asthma in a localised geographical region of the UK

Arms:
arm 1: fluticasone furoate (FF) + vilanterol (VI) once daily via a Novel Dry Powder Inhaler arm 2: inhaled corticosteroid (ICS) alone or in combination with a long acting beta2-agonist (LABA)

Interventions: intervention 1: fluticasone furoate + vilanterol intervention 2: inhaled corticosteroid with or without a long acting beta2-agonist
Intervention descriptions: intervention 1: once daily via a Novel Dry Powder Inhaler intervention 2: ICS alone or in combination with a long acting bronchodilator

Protocol document: