NCT00452764

Brief Summary

Lymphoid follicles, consisting of T-and B cells, are involved in the chronic inflammatory response in COPD. Foxp3 positive regulatory T cells (Tregs) are present in these follicles and may be involved in the suppression of this chronic inflammatory response. We hypothesise that a dysfunction of Tregs underlies the development of the inflammatory response in COPD. This could be either due to a decreased presence of Tregs in COPD, or to an altered function of Tregs possibly caused by a decreased HO-1 expression and/or an altered TGFβ regulation.

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 all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 8, 2007

Status Verified

November 1, 2007

First QC Date

March 26, 2007

Last Update Submit

November 7, 2007

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDHealthyRegulatory T cellHeme oxygenase-1peripheral blood

Interventions

Withdrawal of medicationBEHAVIORAL

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD patients
  • Clinical diagnosed COPD
  • No allergies
  • Post-bronchodilator FEV1 \< 80% predicted, and post-bronchodilator FEV1/FVC \< 70%
  • No use of (inhaled) corticosteroids in the 6 weeks preceding the study
  • Age \> 40
  • Smokers and ex- smokers \> 10 pack years
  • Ex-smokers have to have quitted smoking for at least one year
  • No other major current health problems
  • Informed consent Healthy controls
  • No signs of pulmonary disease
  • No allergies or hyperreactivity
  • No other major current health problems
  • FEV1 \> 90 % predicted, FEV1/FVC \> 70%
  • Age \> 40
  • +4 more criteria

You may not qualify if:

  • Use of (inhaled) corticosteroids in the 6 weeks preceding the study
  • Addiction to alcohol or drugs
  • COPD exacerbation in the 6 weeks preceding the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Huib AM Kerstjens, MD, PhD

    UMCG, department of pulmonary diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2007

First Posted

March 27, 2007

Study Start

January 1, 2007

Study Completion

November 1, 2007

Last Updated

November 8, 2007

Record last verified: 2007-11

Locations

NL(1)