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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00864812

Enrollment

509

Registered

2009-03-19

Start date

2009-03-31

Completion date

2010-03-31

Last updated

2010-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Brief 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)

Interventions

DRUGtiotropium with fluticasone propionate/salmeterol (FSC)

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

DRUGtiotropium

COPD patients treated with tiotropium

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Changes in pre-dose FEV1 from baseline at 24 weeks after treatment	24 weeks

Secondary

Measure	Time frame
Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety	24 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026