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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00159289
Recruitment Status : Withdrawn (No resources available)
First Posted : September 12, 2005
Last Update Posted : June 4, 2015
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Procedure: Inhalation of LPS Procedure: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Inhalation of LPS
Procedure: Inhalation of LPS
Placebo Comparator: 2
Procedure: Placebo

Primary Outcome Measures :
  1. sputum induced

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00159289

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
Principal Investigator: Sergei A Kharitonov, MD, PhD Imperial College London Identifier: NCT00159289     History of Changes
Other Study ID Numbers: 2002AT032B
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: August 2008

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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases