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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
The Korean Academy of Tuberculosis and Respiratory Diseases
ClinicalTrials.gov Identifier:
NCT00864812
First received: March 17, 2009
Last updated: March 29, 2010
Last verified: March 2010
History of Changes

March 17, 2009
March 29, 2010
March 2009
March 2010   (final data collection date for primary outcome measure)
Changes in pre-dose FEV1 from baseline at 24 weeks after treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00864812 on ClinicalTrials.gov Archive Site
Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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)
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • 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 Name: tiotropium: Spiriva
  • Experimental: 1
    tiotropium with fluticasone propionate/salmeterol (FSC)
    Intervention: Drug: tiotropium with fluticasone propionate/salmeterol (FSC)
  • Active Comparator: 2
    tiotropium
    Intervention: Drug: tiotropium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
509
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00864812
112942
No
Sung-Koo, Han /Chairman, The Korean Academy of Tuberculosis and Respiratory Diseases
The Korean Academy of Tuberculosis and Respiratory Diseases
GlaxoSmithKline
Principal Investigator: Jee-Hong Yoo, Professor East West Neo Medical Center
Principal Investigator: Sang-Do Lee, Professor Asan Medical Center
The Korean Academy of Tuberculosis and Respiratory Diseases
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP