Leukocyte Function in Chronic Obstructive Pulmonary Disease (COPD)
Leukocyte Migration and Differentiation in COPD Patients Compared to Healthy Smokers and Healthy Non-smoking Subjects.
1 other identifier
observational
100
1 country
1
Brief Summary
The aim of this study is to investigate the mechanisms whereby leukocytes are recruited to the lung in chronic obstructive pulmonary disease (COPD) and cause tissue destruction. The hypothesis is that in COPD more leukocytes enter the lung and it is these cells that are responsible for the degradation of lung tissue. We, the researchers at Imperial College London, will isolate leukocytes from the blood of patients with COPD, healthy smokers and normal subjects and measure the movement of the leukocytes to chemoattractants. We will examine further, which cell surface receptors are responsible for this trafficking of cells. Furthermore, the differentiation of these cells in vitro will be compared with cells from healthy smokers and normal subjects. Specifically, the expression of enzymes that are responsible for tissue destruction and the cell surface receptors on these cells will be investigated. The objective is to identify the mechanisms whereby leukocytes from COPD patients behave differently to cells from healthy smokers and normal subjects with a view to identify novel targets for drug therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2001
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedResults Posted
Study results publicly available
December 5, 2019
CompletedDecember 5, 2019
December 1, 2019
3.8 years
September 6, 2005
November 6, 2019
December 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Effective Concentration (EC 50) of GRO Alpha
Migration response of PBMC to Chemokine EC 50 represents the concentration of a drug that is required for 50% inhibition in vitro
2 hours
Effective Concentration of IL-8
Migration response of PBMC to Chemokine EC 50 represents the concentration of a drug that is required for 50% inhibition in vitro
2 hours
Effective Concentration of MCP-1
Migration response of PBMC to Chemokine
2 hours
Study Arms (3)
COPD
Patients with COPD - no intervention
Smokers without COPD
Smokers without COPD - no intervention
Non-smokers
Non-smokers with no history of respiratory disease - no intervention
Eligibility Criteria
Patients who had taken inhaled or oral steroids or who had suffered an exacerbation of their airway disease in the previous 6 weeks were excluded.
You may qualify if:
- Healthy Non-Smoking Subjects. All normal volunteers will meet the following criteria:
- Age 21-70 years.
- No history of respiratory or allergic disease.
- Normal baseline spirometry as predicted for age, sex and height.
- Non-smokers.
- No history of upper respiratory tract infection in the preceding six weeks.
- Not taking regular medication
- COPD Subjects. COPD is diagnosed according to American Thoracic Society, European Respiratory Society and British Thoracic Society guidelines. All COPD volunteers will meet the following criteria:
- Age between 40-75 years.
- A smoking history of at least 20 pack years. (1 pack year = 20 packs of cigarettes per day for 1 year)
- Forced expiratory volume at 1 second : Forced vital capacity (FEV1:FVC) ratio of \<0.7, post-bronchodilator FEV1 of \<85% predicted, reversibility with inhaled beta2-agonist of \<15% of predicted FEV1: all three criteria are required.
- Current smokers or smokers who had ceased smoking for at least 6 months.
- No history of exacerbation, oral steroid or antibiotic use within the preceding 6 weeks.
- Normal serum alpha-1 antitrypsin level.
- No history of other respiratory or allergic disease.
- +8 more criteria
You may not qualify if:
- Clinically significant findings in the medical history or on physical examination other than those of COPD in the COPD group.
- Pregnant women or mothers who are breastfeeding.
- Subjects who are unable to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Brompton Hospital/NHLI Imperial College London
London, SW3 6LY, United Kingdom
Related Publications (1)
Traves SL, Smith SJ, Barnes PJ, Donnelly LE. Specific CXC but not CC chemokines cause elevated monocyte migration in COPD: a role for CXCR2. J Leukoc Biol. 2004 Aug;76(2):441-50. doi: 10.1189/jlb.1003495. Epub 2004 May 20.
PMID: 15155777RESULT
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor Louise Donnelly
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Louise E Donnelly, PhD
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 7, 2005
Study Start
February 1, 2001
Primary Completion
December 1, 2004
Study Completion
April 1, 2007
Last Updated
December 5, 2019
Results First Posted
December 5, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share