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

Not Applicable

Withdrawn

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Procedure: Placebo; Procedure: Inhalation of LPS

• Registration Number: NCT00159289
• Lead Sponsor: Imperial College London

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	PLacebo
1	Inhalation of LPS	Inhalation of LPS

Primary Outcome Measures

Name	Time	Method
sputum induced

Trial Locations

Locations (1)

Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital; 🇬🇧 London, United Kingdom