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

The Korean Academy of Tuberculosis and Respiratory Diseases32 sites in 1 country509 target enrollmentMarch 2009

Overview

Phase: Phase 4
Intervention: tiotropium with fluticasone propionate/salmeterol (FSC)
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: The Korean Academy of Tuberculosis and Respiratory Diseases
Enrollment: 509
Locations: 32
Primary Endpoint: Changes in pre-dose FEV1 from baseline at 24 weeks after treatment
Status: Completed
Last Updated: 16 years ago

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

Study assessment

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

March 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

The Korean Academy of Tuberculosis and Respiratory Diseases

•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.