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Endotoxin and Inflammatory Markers in Healthy Non-Smokers and Current Smokers Including Patients With Chronic Obstructive Pulmonary Disease (COPD)
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
1 other identifier
interventional
N/A
1 country
1
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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2003
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
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedApril 4, 2024
April 1, 2024
Same day
September 8, 2005
April 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sputum induced
Study Arms (2)
1
EXPERIMENTALInhalation of LPS
2
PLACEBO COMPARATORPLacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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)
- : 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, SW3 6LY, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sergei A Kharitonov, MD, PhD
Imperial College London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
June 1, 2003
Primary Completion
June 1, 2003
Study Completion
June 1, 2003
Last Updated
April 4, 2024
Record last verified: 2024-04