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

COMPLETEDPHASE4

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

NCT00864812•The Korean Academy of Tuberculosis and Respiratory Diseases

View on ClinicalTrials.gov

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)

Eligibility

Age

40 - 80 years

Sex

ALL

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.

Locations (32)

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Inje university Pusan Paik hospital

Busan, South Korea

Chonbuk national university hospital

Chunbuk, South Korea

Keimyung university dongsan medical center

Daegu, South Korea

Kyungpook national university hospital

Daegu, South Korea

Yeungnam University Hospital

Daegu, South Korea

Hallym University scared heart hospital

Gyeonggi-do, South Korea

Gachon University Gil Hospital

Inchon, South Korea

Incheon St. Mary's Hospital

Inchon, South Korea

Inha university Hospital

Inchon, South Korea

Key Dates

Start Date

March 1, 2009

Primary Completion Date

March 1, 2010

Completion Date

March 1, 2010

Last Updated

March 31, 2010

Enrollment

509

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

tiotropium with fluticasone propionate/salmeterol (FSC)

DRUG

tiotropium

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

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RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 31, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Probiotics in Pulmonaty Rehabilitation for COPD

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