NCT00175565

Brief Summary

Systemic inflammation is present in chronic obstructive pulmonary disease (COPD), which has been linked to cardiovascular morbidity and mortality. We determined the effects of oral and inhaled corticosteroids on serum markers of inflammation in patients with stable COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2002

Geographic Reach
1 country

2 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 1, 2002

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

July 28, 2010

Status Verified

July 1, 2010

First QC Date

September 11, 2005

Last Update Submit

July 26, 2010

Conditions

Chronic Obstructive Pulmonary DiseaseEmphysemaChronic Bronchitis

Keywords

inflammationtrialfluticasone

Outcome Measures

Primary Outcomes (1)

  • Change in serum C-reactive protein (CRP) levels

Secondary Outcomes (1)

  • Change in serum interleukin-6 and monocyte chemoattractant protein-1 levels

Interventions

inhaled fluticasone 500 mcg b.i.d.DRUG

Eligibility Criteria

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

You may qualify if:

  • stable symptoms of COPD in the previous 3 months before study entry; forced expiratory volume in one second (FEV1) after bronchodilation with 400 mcg salbutamol that was 25 to 90% of predicted, a change of less than 20% of predicted FEV1, 30 minutes following bronchodilation, and a FEV1/forced vital capacity (FVC) of less than 75%; history of at least 10 pack-years of smoking or prolonged exposure (\>10 years) to noxious gases (e.g. diesel fumes).

You may not qualify if:

  • active malignancy; unable to follow instructions; patients taking any anti-inflammatory medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G 2R7, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6Z 1Y7, Canada

Location

Related Publications (2)

  • Sin DD, Lacy P, York E, Man SF. Effects of fluticasone on systemic markers of inflammation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Oct 1;170(7):760-5. doi: 10.1164/rccm.200404-543OC. Epub 2004 Jun 30.

    PMID: 15229100RESULT

  • Man SF, Sin DD. Effects of corticosteroids on systemic inflammation in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2005;2(1):78-82. doi: 10.1513/pats.200406-034MS.

    PMID: 16113473RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysemaBronchitis, ChronicInflammation

Condition Hierarchy (Ancestors)

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

Study Officials

  • Paul Man, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 15, 2005

Study Start

January 1, 2002

Study Completion

July 1, 2003

Last Updated

July 28, 2010

Record last verified: 2010-07

Locations

CA(2)