Endotoxin and Inflammatory Markers in Healthy Non-Smokers and Current Smokers Including Patients With Chronic Obstructive Pulmonary Disease (COPD)
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Details and patient eligibility
About
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).
Sex
Ages
Volunteers
Inclusion criteria
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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)
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0: At risk (current or ex-smokers): normal spirometry, with or without chronic symptoms (cough, sputum production)
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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)
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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