NCT00549146

Brief Summary

Relatively little information is available about the effects of salmeterol/fluticasone combination and fluticasone alone in COPD patients with a partial reversible pulmonary obstruction. The purpose of this study is to compare the effects of salmeterol/fluticasone combination with fluticasone alone delivered via Diskus/ACCUHALER inhaler in subjects with COPD on lung function over a 1 year period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

17 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

November 1, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

2.4 years

First QC Date

October 24, 2007

Last Update Submit

January 19, 2017

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

reversibilityCOPDlung function

Outcome Measures

Primary Outcomes (1)

  • Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted.

Secondary Outcomes (1)

  • Reversibility of lung function with salbutamol and on Forced Vital capacity (FVC), TLC, FRC, FVC, Inspiration capacity(IC), Forced Inspiratory Volume in 1 second (FIV1) and Maximum mid-Expiratory Flow (MEF50).

Interventions

fluticasone propionate/salmeterol 250/50 DISKUS combination productDRUG
fluticasone propionate DISKUS 500mcgDRUG
Also known as: fluticasone propionate/salmeterol 250/50 DISKUS combination product

Eligibility Criteria

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

You may qualify if:

  • Established history of chronic obstructive pulmonary disease (COPD).
  • Lung function parameters: FEV1/FVC ratio \< 70%, FEV1 between 80% and 30% predicted, a reversibility of airway obstruction of 12% of the initial value with a minimum of 200 mL.
  • Signed and dated informed consent.

You may not qualify if:

  • History of asthma or allergy.
  • Unstable COPD in the 3 months before the study.
  • Interference of non-pulmonary medication or diseases with COPD outcome parameters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

GSK Investigational Site

Alkmaar, 1815 JD, Netherlands

Location

GSK Investigational Site

Almelo, 7609 PP, Netherlands

Location

GSK Investigational Site

Amsterdam, 1034 CS, Netherlands

Location

GSK Investigational Site

Amsterdam, 1058 NR, Netherlands

Location

GSK Investigational Site

Amsterdam, 1091 AC, Netherlands

Location

GSK Investigational Site

Drachten, 9202 NN, Netherlands

Location

GSK Investigational Site

Haarlem, 2012 CE, Netherlands

Location

GSK Investigational Site

Harderwijk, 3844 DG, Netherlands

Location

GSK Investigational Site

Hengelo, 7555 DL, Netherlands

Location

GSK Investigational Site

Hoorn, 1624 NP, Netherlands

Location

GSK Investigational Site

Leeuwarden, 8934 AD, Netherlands

Location

GSK Investigational Site

Meppel, 7943 KA, Netherlands

Location

GSK Investigational Site

Nijmegen, 6532 SZ, Netherlands

Location

GSK Investigational Site

Rotterdam, 3045 PM, Netherlands

Location

GSK Investigational Site

Sneek, 8601 ZK, Netherlands

Location

GSK Investigational Site

Utrecht, 2584 CX, Netherlands

Location

GSK Investigational Site

Voerendaal, 6367 ED, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

November 1, 2003

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

January 20, 2017

Record last verified: 2017-01

Locations

NL(17)