Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Exacerbation Adult COPD Respiratory
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2802
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)) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing COPD maintenance therapy over twelve months in subjects diagnosed with COPD. 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 COPD in a localised geographical region of the UK

Arms:
arm 1: once daily via a Novel Dry Powder Inhaler arm 2: Existing Maintenance Therapy:

* Long acting bronchodilator therapy alone
* ICS alone or in combination with a long acting bronchodilator
* Triple maintenance therapy

Interventions: intervention 1: FF/VI intervention 2: Existing Maintenance Therapy
Intervention descriptions: intervention 1: FF/VI intervention 2: Existing Maintenance Therapy:

* Long acting bronchodilator therapy alone
* ICS alone or in combination with a long acting bronchodilator
* Triple maintenance therapy

Protocol document: