Status:
WITHDRAWN
Endotoxin and Inflammatory Markers in Healthy Non-Smokers and Current Smokers Including Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Imperial College London
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The primary aim of this study is to investigate the effects of inhaled lipopolysaccharide endotoxin (LPS) on bronchial and alveolar exhaled nitric oxide (NO) and NO metabolites and other inflammatory ...
Eligibility Criteria
Inclusion
- Healthy non-smokers: normal spirometry (forced expiratory volume in 1 second \[FEV1\] more than or equal to 90% predicted) and normal exhaled NO (between 8 and 24 ppb; flow 50 ml/s)
- 0: At risk (current or ex-smokers): normal spirometry, with or without chronic symptoms (cough, sputum production)
- I-II: Mild-moderate COPD
- FEV1 reversibility of \< 15% after inhaled beta2-agonists
- FEV1/forced vital capacity (FVC) \< 70% predicted
- FEV1 between greater than or equal to 50% and less than 80%
- With or without chronic symptoms (cough, sputum production)
- Able to comprehend and grant a written informed consent
Exclusion
- Concomitant use or pre-treatment within the last 4 weeks with oral steroids
- Respiratory infection within 4 weeks prior to entry into the trial
- Females who are pregnant or lactating
- History of current or past drug or alcohol abuse
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00159289
Start Date
June 1 2003
End Date
June 1 2003
Last Update
April 4 2024
Active Locations (1)
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1
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, United Kingdom, SW3 6LY