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OpenTrials
Completed

NCT Number: NCT00864812

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

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)

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soonchunhyang University Bucheon Hospital, Bucheon-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tiotropium with fluticasone propionate/salmeterol (FSC)

Drug

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

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

Tiotropium

Drug

COPD patients treated with tiotropium

Other names: tiotropium: Spiriva

Primary outcomes

  1. Changes in pre-dose FEV1 from baseline at 24 weeks after treatment

    Time frame: 24 weeks

Secondary outcomes

  1. Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

The Korean Academy of Tuberculosis and Respiratory Diseases

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 19, 2009
Registry last updated
Mar 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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