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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00159289

Enrollment

Registered

2005-09-12

Start date

2003-06-30

Completion date

2003-06-30

Last updated

2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Mild to moderate Chronic Obstructive Pulmonary Disease (COPD), Volunteers (healthy non-smokers), Volunteers (current or ex-smokers)

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).

Interventions

PROCEDUREInhalation of LPS

PROCEDUREPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
sputum induced	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026