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)

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: tiotropium with fluticasone propionate/salmeterol (FSC); Drug: tiotropium

• Study Type: Interventional
• Enrollment (Actual): 509
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Soonchunhyang University Bucheon Hospital
  • Busan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • Chunbuk, Korea, Republic of
    • Chonbuk National University Hospital
  • Chungbuk, Korea, Republic of
    • Chungbuk National University Hospital
  • Chungnam, Korea, Republic of
    • Chungnam National University Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital
  • Daegu, Korea, Republic of
    • Yeungnam University Hospital
  • Gyeonggi-do, Korea, Republic of
    • Hallym University scared heart hospital
  • Inchon, Korea, Republic of
    • Inha University Hospital
  • Inchon, Korea, Republic of
    • Gachon University Gil Hospital
  • Inchon, Korea, Republic of
    • Incheon St. Mary's Hospital
  • Jinju, Korea, Republic of
    • Gyeongsang National University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Kyunghee University Medical Center
  • Seoul, Korea, Republic of
    • Inje University Seoul Paik Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Soonchunhyang University Hospital
  • Seoul, Korea, Republic of
    • Boramae Medical Center
  • Seoul, Korea, Republic of
    • Hanyang University Hospital
  • Seoul, Korea, Republic of
    • Konkuk University Hospital
  • Seoul, Korea, Republic of
    • St. Paul's Hospital
  • Seoul, Korea, Republic of
    • KangNam St. Mary's Hospital
  • Seoul, Korea, Republic of, 134-727
    • Kyunghee university east-west neo medical center
  • Seoul, Korea, Republic of
    • Kangdong Scared heart Hospital
  • Suwon, Korea, Republic of
    • Ajou University Hospital
  • Uijeongbu, Korea, Republic of
    • Uijeongbu St. Mary's Hospital
  • Wonju, Korea, Republic of
    • Wonju Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; tiotropium with fluticasone propionate/salmeterol (FSC)	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
Active Comparator: 2; tiotropium	Drug: tiotropium; COPD patients treated with tiotropium; Other Names: tiotropium: Spiriva

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Korean Academy of Tuberculosis and Respiratory Diseases
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Jee-Hong Yoo, Professor, East West Neo Medical Center; Principal Investigator: Sang-Do Lee, Professor, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: March 17, 2009
• First Submitted That Met QC Criteria: March 18, 2009
• First Posted (Estimate): March 19, 2009

Study Record Updates

• Last Update Posted (Estimate): March 31, 2010
• Last Update Submitted That Met QC Criteria: March 29, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Sympathomimetics; Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Tiotropium Bromide
• Other Study ID Numbers: 112942