Conditions: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2488
Healthy volunteers: no

Brief summary:
This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.

Detailed description:

Arms:
arm 1: fluticasone priopionate high dose and tiotropium inhalation and salmeterol xinafoate arm 2: fluticasone priopionate medium and high doses; and tiotropium inhalation; and salmeterol xinafoate; and placebo matched to fluticasone priopionate

Interventions: intervention 1: tiotropium inhalation intervention 2: salmeterol xinafoate intervention 3: fluticasone propionate intervention 4: placebo matched for fluticasone propionate
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: