GR Defect in Peripheral Blood Mononuclear Cells in COPD

This study has been completed.

Sponsor:

Collaborator:

AstraZeneca

Information provided by:

Imperial College London

ClinicalTrials.gov Identifier:

NCT00159237

First received: September 8, 2005

Last updated: August 12, 2008

Last verified: August 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

August 12, 2008

Start Date ^ICMJE

February 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00159237 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

GR Defect in Peripheral Blood Mononuclear Cells in COPD

Official Title ^ICMJE

GR Defect in Peripheral Blood Mononuclear Cells in COPD

Brief Summary

T.to investigate a possible mechanism of the glucocorticosteroid receptors (GR) defect in patients with severe COPD by studying the effect of dexamethasone (Dex) on GR- binding, interleukin production (IL-6/IL-8) and MKP-1 expression in peripheral blood mononuclear cells blood (PBMC)

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease

Intervention ^ICMJE

Procedure: blood test

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with severe (stage III, Gold) to very severe (stage IV, GOLD) COPD or subjects who are healthy smokers or subjects who are non-smokers
Written informed consent

Exclusion Criteria:

Current upper respiratory tract infections
Any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study
Subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason

Gender

Both

Ages

35 Years to 85 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00159237

Other Study ID Numbers ^ICMJE

D5899N00007

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Imperial College London

Collaborators ^ICMJE

AstraZeneca

Investigators ^ICMJE

Principal Investigator:

Sergei A Kharitonov, MD PhD

Imperial College London

Information Provided By

Imperial College London

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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