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

This study has been withdrawn prior to enrollment.
(No resources available)
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00159289
First received: September 8, 2005
Last updated: August 28, 2008
Last verified: August 2008
History of Changes
  Purpose

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).


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Procedure: Inhalation of LPS
Procedure: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • sputum induced

Estimated Enrollment: 36
Study Start Date: June 2003
Arms Assigned Interventions
Experimental: 1
Inhalation of LPS
 Procedure: Inhalation of LPS
Placebo Comparator: 2
PLacebo
 Procedure: Placebo

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159289

Locations
United Kingdom
Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Sergei A Kharitonov, MD, PhD Imperial College London
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00159289     History of Changes
Other Study ID Numbers: 2002AT032B
Study First Received: September 8, 2005
Last Updated: August 28, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Mild to moderate Chronic Obstructive Pulmonary Disease (COPD)
Volunteers (healthy non-smokers)
Volunteers (current or ex-smokers)

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013