MedTrace Logo

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

NCT00864812 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 509

Last updated 2010-03-31

No results posted yet for this study

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)

Conditions

Interventions

DRUG

tiotropium with fluticasone propionate/salmeterol (FSC)

COPD patients treated with tiotropium with fluticasone propionate/salmeterol (FSC)

DRUG

tiotropium

COPD patients treated with tiotropium

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • The Korean Academy of Tuberculosis and Respiratory Diseases

    lead OTHER

Principal Investigators

  • Jee-Hong Yoo, Professor · East West Neo Medical Center

  • Sang-Do Lee, Professor · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00864812 on ClinicalTrials.gov