Chronic Obstructive Pulmonary DiseasePhase 4NCT00864812

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

A Phase 4 study testing tiotropium with fluticasone propionate/salmeterol (FSC) and tiotropium in people with Chronic Obstructive Pulmonary Disease, run by The Korean Academy of Tuberculosis and Respiratory Diseases at 32 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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)… Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: tiotropium with fluticasone propionate/salmeterol (FSC) and tiotropium
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 509 participants
Where: 32 sitesSouth Korea
Study dates: Mar 2009to Mar 2010
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

South Korea32 sites

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

Other trials in South Korea

About this study

Official 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 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)

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: tiotropium with fluticasone propionate/salmeterol (FSC), tiotropium
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tiotropium with fluticasone propionate/salmeterol (FSC)Drug
Also called tiotropium]:Spiriva, fluticasone propionate/salmeterol (FSC): Seretide
COPD patients treated with tiotropium with fluticasone propionate/salmeterol (FSC)
tiotropiumDrug
Also called tiotropium: Spiriva
COPD patients treated with tiotropium

Study groups in NCT00864812
Study group	Role	What they receive
1	Experimental	tiotropium with fluticasone propionate/salmeterol (FSC) Receives: Drug: tiotropium with fluticasone propionate/salmeterol (FSC)
2	Active comparator	tiotropium Receives: Drug: tiotropium

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in pre-dose FEV1 from baseline at 24 weeks after treatment
Measured: 24 weeks

Secondary outcomes (1)

Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Mar 2010

First posted19 Mar 2009 (estimated)
Study startMar 2009
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 509 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00864812
Sponsor's protocol ID: 112942
Status last verified: Mar 2010
First submitted: 17 Mar 2009
Last updated: 31 Mar 2010
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT00864812
Acronym / sponsor ID: 112942
Conditions: Chronic Obstructive Pulmonary Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 509 participants (actual)
Lead sponsor: The Korean Academy of Tuberculosis and Respiratory DiseasesUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: Mar 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 19 Mar 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: tiotropium with fluticasone propionate/salmeterol (FSC)tiotropium with fluticasone propionate/salmeterol (FSC)
2	Active comparator	Drug: tiotropiumtiotropium

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tiotropium with fluticasone propionate/salmeterol (FSC)Also: tiotropium]:Spiriva, fluticasone propionate/salmeterol (FSC): SeretideCOPD patients treated with tiotropium with fluticasone propionate/salmeterol (FSC)	Drug	1
tiotropiumAlso: tiotropium: SpirivaCOPD patients treated with tiotropium	Drug	2

Primary outcome

Changes in pre-dose FEV1 from baseline at 24 weeks after treatment
Time frame: 24 weeks

1 secondary outcome

Changes in pre-dose FEV1 from baseline and IC from baseline, COPD exacerbation, QoL and safety
Time frame: 24 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2010.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jee-Hong Yoo, Professor principal investigator

East West Neo Medical Center

Sang-Do Lee, Professor principal investigator

Asan Medical Center

32 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in pre-dose FEV1 from baseline at 24 weeks after treatment (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00864812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2010.