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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00159289
First Posted: September 12, 2005
Last Update Posted: June 4, 2015
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.
Information provided by:
Imperial College London
  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 (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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • sputum induced

Enrollment: 0
Study Start Date: June 2003
Arms Assigned Interventions
Experimental: 1
Inhalation of LPS
Procedure: Inhalation of LPS
Placebo Comparator: 2
PLacebo
Procedure: Placebo

  Eligibility

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
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00159289     History of Changes
Other Study ID Numbers: 2002AT032B
First Submitted: September 8, 2005
First Posted: September 12, 2005
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