NCT00358358

Brief Summary

This study will last for approximately 14 weeks and will involve 5 visits. The study is being carried out to look at different ways of measuring the effect of drug treatment on COPD. COPD is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient. The effects of drug treatment are usually measured by conducting lung function tests (breathing tests) using a machine called a spirometer but this does not always provide a complete picture of how well your COPD is responding. In this study we therefore want to look at new and more sensitive ways of measuring COPD. The results of this research will help in the assessment of new drugs for COPD in the future.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_4

Geographic Reach
4 countries

11 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

March 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

July 27, 2006

Last Update Submit

January 19, 2017

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPDImpulse Oscillometry SystemComputerized Tomography

Outcome Measures

Primary Outcomes (1)

  • Peripheral airway resistance measured by IOS

Secondary Outcomes (1)

  • Airway wall thickness measured by CT scans

Interventions

Fluticasone Propionate/Salmeterol 500/50mcg combinationDRUG
Fluticasone Propionate 500mcgDRUG
Salmeterol 50mcgDRUG
Also known as: Fluticasone Propionate/Salmeterol 500/50mcg combination, Fluticasone Propionate 500mcg

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of COPD
  • Current or ex-smoker at least 10 pack- years

You may not qualify if:

  • Diagnosis of asthma
  • Active respiratory disorder other than COPD
  • Evidence of clinically significant uncontrolled non-pulmonary disease
  • Carcinoma not in complete remission for last 5 years
  • Lung volume reduction surgery in previous 12 months
  • Nocturnal positive pressure for sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

GSK Investigational Site

Absecon, New Jersey, 8201, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29406-7108, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Valparaíso, Región de Valparaíso, 2341131, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7500691, Chile

Location

GSK Investigational Site

Tartu, 51014, Estonia

Location

GSK Investigational Site

Barnaul, 656 045, Russia

Location

GSK Investigational Site

Moscow, 105 077, Russia

Location

GSK Investigational Site

Moscow, 105 229, Russia

Location

GSK Investigational Site

Nizhnekamsk, 423570, Russia

Location

Related Publications (1)

  • Kreindler JL, Watkins ML, Lettis S, Tal-Singer R, Locantore N. Effect of inhaled corticosteroids on blood eosinophil count in steroid-naive patients with COPD. BMJ Open Respir Res. 2016 Sep 8;3(1):e000151. doi: 10.1136/bmjresp-2016-000151. eCollection 2016.

    PMID: 27651909DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

FluticasoneSalmeterol Xinafoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2006

First Posted

July 31, 2006

Study Start

March 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

January 20, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Available IPD Datasets

Clinical Study Report (SCO104925)Access
Informed Consent Form (SCO104925)Access
Individual Participant Data Set (SCO104925)Access
Statistical Analysis Plan (SCO104925)Access
Dataset Specification (SCO104925)Access
Study Protocol (SCO104925)Access
Annotated Case Report Form (SCO104925)Access

Locations

US(4)ES(1)CL(2)RU(4)