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NCT00159289 Clinical Trial

Endotoxin and Inflammatory Markers in Healthy Non-Smokers and Current Smokers Including Patients With Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
Effect of Endotoxin on Inflammatory Markers in Exhaled Breath, Sputum, Saliva and Nasal Lavage in Healthy Non-Smokers and Current Smokers Including Patients With COPD

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00159289
Other study ID # 2002AT032B
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 2003
Est. completion date June 2003

Study information
Verified date April 2024
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 markers and mediators in exhaled breath condensate, induced sputum, nasal lavage and mouthwash fluid in healthy non-smokers and current smokers, including patients with chronic obstructive pulmonary disease (COPD).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2003
Est. primary completion date June 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 75 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Inhalation of LPS

• Placebo

Locations
Country Name City State
United Kingdom Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital London

Sponsors (1)
Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary sputum induced
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