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Regulatory T Cells in COPD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00452764
First Posted: March 27, 2007
Last Update Posted: November 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Groningen Research Institute for Asthma and COPD
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease Behavioral: Withdrawal of medication

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Phenotype and Number of Regulatory T Cells Present in Peripheral Blood of COPD Patients Versus Healthy Controls

Further study details as provided by Groningen Research Institute for Asthma and COPD:

Estimated Enrollment: 50
Study Start Date: January 2007
Study Completion Date: November 2007
Detailed Description:

COPD is a leading cause of death worldwide and its morbidity and mortality are still rising.So far, no effective treatment is available To find better treatment methods more insight is needed in the nature/origin of the chronic inflammation that underlies the development of COPD.

The important role of neutrophils, macrophages and cytotoxic T cells is well established in this respect, yet the role of CD4 T cells and B cells has only recently (re)attracted attention. We detected the presence of lymphoid follicles in lung tissue of COPD patients, consisting of B cells surrounded by T cells. Recently, we have found the presence of Foxp3 positive T cells as a component of these lymphoid follicles in COPD. Since Foxp3 is a distinctive marker of regulatory T cells (Tregs), this finding suggests that Tregs are involved in the inflammatory response in COPD.

Tregs are important in controlling immunological tolerance and preventing auto-immune responses by inhibiting T-cell responses. Dysfunction of Tregs can lead to auto-immune diseases, allergy and chronic inflammatory diseases. However, nothing is known so far about their contribution to the chronic inflammatory response in COPD. Recent studies show that, next to direct inhibition by cell-cell contact, the inhibitory effects of Tregs are mediated by heme oxygenase-1 (HO-1) expression and membrane bound TGFβ.

We hypothesise that a dysfunction of regulatory T cells underlies the development of the inflammatory response in COPD. This could be due to a decreased presence of Tregs in COPD, or to an altered function of Tregs. The latter may be due to a decreased HO-1 expression, as we have shown in macrophages of COPD patients compared to those in healthy controls, and/or an altered TGFβ regulation, a cytokine that plays a prime role in COPD.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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
  • Never smokers, i.e. no cigarettes last year, and maximal 5 pack years
  • Smokers and ex- smokers > 10 pack years
  • Ex-smokers have to have quitted smoking for at least one year
  • Informed consent

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452764


Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands
Sponsors and Collaborators
Groningen Research Institute for Asthma and COPD
Investigators
Principal Investigator: Huib AM Kerstjens, MD, PhD UMCG, department of pulmonary diseases
  More Information

ClinicalTrials.gov Identifier: NCT00452764     History of Changes
Other Study ID Numbers: METc2006-135
First Submitted: March 26, 2007
First Posted: March 27, 2007
Last Update Posted: November 8, 2007
Last Verified: November 2007

Keywords provided by Groningen Research Institute for Asthma and COPD:
COPD
Healthy
Regulatory T cell
Heme oxygenase-1
peripheral blood

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases