Trial | NCT00864812  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    509
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)
Study Started
Mar 31
2009
Primary Completion
Mar 31
2010
Study Completion
Mar 31
2010
Last Update
Mar 31
2010
Estimate

Drug tiotropium with fluticasone propionate/salmeterol (FSC)

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

  • Other names: tiotropium]:Spiriva, fluticasone propionate/salmeterol (FSC): Seretide

Drug tiotropium

COPD patients treated with tiotropium

  • Other names: tiotropium: Spiriva

1 Experimental

tiotropium with fluticasone propionate/salmeterol (FSC)

2 Active Comparator

tiotropium

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.
No Results Posted