NCT00269126

Brief Summary

This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 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
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
5 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
Last Updated

April 15, 2013

Status Verified

May 1, 2012

Enrollment Period

6 months

First QC Date

December 21, 2005

Last Update Submit

April 11, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPDChronic BronchitisEmphysema

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg

Secondary Outcomes (4)

  • Change in morning PEF

  • Changes in pre-dose FVC, V50, V25

  • Use of rescue medication

  • Changes in symptom scores

Interventions

fluticasone propionate/salmeterol combination DISKUSDRUG
salmeterol xinafoateDRUG
Also known as: fluticasone propionate/salmeterol combination DISKUS

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 (2)

GSK Investigational Site

Kyoto, 602-8026, Japan

Location

GSK Investigational Site

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, ChronicEmphysema

Interventions

FluticasoneSalmeterol Xinafoate

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 CompoundsAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 23, 2005

Study Start

February 1, 2005

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

April 15, 2013

Record last verified: 2012-05

Locations

JP(1)