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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Korean Academy of Tuberculosis and Respiratory Diseases
• Collaborator: GlaxoSmithKline
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate; Tiotropium Bromide; Xhance

Criteria

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.