Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea

A Randomized, Open Label, Multicenter, Phase 4 Study for the Comparison of Efficacy of Tiotropium Plus Salmeterol/ Fluticasone Propionate Compared With Tiotropium Alone in COPD Patients

Study title

• A randomized, open label, multicenter, phase 4 study for the comparison of efficacy of tiotropium plus salmeterol/ fluticasone propionate compared with tiotropium alone in COPD patients

Study objectives

• To investigate clinical outcomes of combining tiotropium with fluticasone propionate/salmeterol (FSC) 250/50μg bid compared with tiotropium alone in patients with moderate or severe COPD in Korea

Study Design

• Randomized, open-label, multicenter, parallel-group, two group study

Study assessment

• FEV1
• Inspiratory capacity (IC)
• History of COPD exacerbation
• History of hospitalization for COPD exacerbation and all causes
• QoL (SGRQ-C)

Inclusion Criteria:

• Subjects Aged 40 to 80 years.
• Subjects diagnosed with COPD.
• Tobacco smoking 10 pack-years or more.
• Subjects with post-bronchodilator FEV1/FVC < 0.7 and FEV1 < 65% predicted.

Exclusion Criteria:

• Subjects with a history of physician-diagnosed asthma or a respiratory disorder other than COPD which is clinically significant such as diffuse bilateral bronchiectasis.
• Subjects suffering from serious diseases likely to interfere with the study such as chronic congestive heart failure.
• Subjects who used systemic corticosteroids within 4 weeks prior to study entry.
• Subjects with any malignant disease.
• Subjects with a history of severe glaucoma, urinary tract obstruction.
• Previous lung volume reduction surgery.
• Subjects who are pregnant or breastfeeding.
• Subjects with a known hypersensitivity or intolerance to tiotropium or fluticasone-salmeterol.