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GR Defect in Sputum Cells in COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Terminated
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
Induced Sputum
Sponsored by
Imperial College London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: Patients with moderate (stage II, 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

Sites / Locations

  • Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
April 12, 2019
Sponsor
Imperial College London
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00159276
Brief Title
GR Defect in Sputum Cells in COPD
Official Title
GR Defect in Sputum Cells in COPD
Study Type
Observational

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
To investigate a possible mechanism of the GR defect in patients with severe COPD by studying the effect of dexamethasone (Dex) on GR-GRE binding, expression of inflammatory and anti-inflammatory factors such as IL-6, IL-8, MKP-1, GILZ, SLPI production in sputum cells

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Induced Sputum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Eligibility Criteria
Inclusion Criteria: Patients with moderate (stage II, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergei A Kharitonov, MD PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6LY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

GR Defect in Sputum Cells in COPD

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