Status:
COMPLETED
Regulation of Inflammatory Mediators in Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Gene Logic
Conditions:
COPD
Emphysema
Eligibility:
All Genders
21-70 years
Brief Summary
The aim of this study is to investigate the mechanisms whereby lung function is decreased in COPD. The hypothesis is that in diseases such as COPD, inflammatory cells including neutrophils, macrophage...
Detailed Description
This study involves a comparison of the inflammatory responses of leukocytes derived from 3 separate subject groups. The aim of the study is to compare the responses of leukocytes from patients with C...
Eligibility Criteria
Inclusion
- 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 by the doctors in Professor Barnes' COPD clinic.
- 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 cigarettes per day for 1 year)
- 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.
- No evidence of atopy on skin prick testing to common aeroallergens (grass pollen, cat hair, house dust mite or Aspergillus fumigatus These tests will have already been performed as part of routine assessment in Professor Barnes' COPD clinic and we will not need to repeat them for this study.
- Healthy Smokers
- All healthy smoking volunteers in trials will meet the following criteria:
- Age 21-70 years.
- Smoking history of at least 10 pack years. (1 pack year = 20 cigarettes per day for 1 year).
- No history of respiratory or allergic disease.
- Normal baseline spirometry as predicted for age, sex and height.
- No history of upper respiratory tract infection in the preceding six weeks.
- Not taking regular medication.
Exclusion
- Subjects will not included in this study if they meet any of the following exclusion criteria:
- 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.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00147095
Start Date
February 1 2003
End Date
February 1 2005
Last Update
November 14 2019
Active Locations (1)
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1
Royal Brompton Hospital/NHLI Imperial College London
London, United Kingdom, SW3 6LY