NCT00269087

Brief Summary

This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2006

Completed
12.3 years until next milestone

Results Posted

Study results publicly available

February 1, 2019

Completed
Last Updated

February 1, 2019

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

December 21, 2005

Results QC Date

June 30, 2017

Last Update Submit

August 30, 2018

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic BronchitisCOPDEmphysema

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)

    AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

    Up to Week 56

Secondary Outcomes (24)

  • Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters

    Up to Week 56

  • Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters

    Up to Week 56

  • Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters

    Up to Week 56

  • Mean Change From Baseline in Level of Plasma Cortisol 1

    Baseline and Week 24 and 52

  • Mean Level of Plasma Cortisol 2

    Up to Week 56

  • +19 more secondary outcomes

Interventions

fluticasone propionate/salmeterol combination DISKUSDRUG

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of COPD.

You may not qualify if:

  • Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

GSK Investigational Site

Kodaira, 187-0002, Japan

Location

GSK Investigational Site

Kyoto, 612-0026, Japan

Location

GSK Investigational Site

Osaka, 596-8501, Japan

Location

GSK Investigational Site

Tokyo, 164-0012, Japan

Location

GSK Investigational Site

Location

Related Publications (1)

  • This study has not been published in the scientific literature.

    BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, ChronicEmphysema

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 23, 2005

Study Start

January 28, 2005

Primary Completion

October 1, 2006

Study Completion

October 25, 2006

Last Updated

February 1, 2019

Results First Posted

February 1, 2019

Record last verified: 2018-08

Locations

JP(4)