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Validation of Biomarkers of Exposure and Host Response

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 2, 2007
Last Update Posted: January 5, 2010
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.
Institute for Science and Health
Information provided by:
University of Nebraska

The proposed study will evaluate biomarkers measured in exhaled breath condensate (EBC) for the purpose of assessing clinical strategies of harm reduction. It will take advantage of a recently developed device that permits collection of exhaled breath condensate reproducibly, with minimal subject effort and with no oral contamination. The major goal of the trial is to provide evidence to validate biomarkers in EBC.

This will be accomplished by collecting samples from asymptomatic smokers before and after inducing a change in their smoking habit (cessation or reduction) with the aid of partial nicotine replacement.

Measures to be made in EBC include H2O2, the most widely explored biomarker in this "body" fluid. Methods that reliably can quantify levels in normal non-smokers and in asymptomatic smokers will be used. Two fold increases in smokers have been reported by in several reports and confirmed in preliminary data by the investigators. In addition, other biomarkers of oxidant stress: TBARs, 8-isoprostane and nitrotyrosine will be quantified using standard methods.

Biomarkers quantified in EBC will be assessed for reliability (i.e. reproducibility and for sensitivity) to change and for validity (by comparison to clinically defined endpoints and previously validated measures of exposure). Reproducibility will be assessed by making repeated measurements in the same subjects on different occasions. Sensitivity to change will be assessed by comparing values before and after changing smoking habit. Finally, the validity of the biomarkers will be assessed by comparing them to previous measures of smoke exposure (CO, NNAL and NNAL-glc) and to clinically defined endpoints: symptoms, the St. George's Respiratory Questionnaire and post bronchodilator lung function. With regard to the latter measures, preliminary data indicate that symptoms can be detected in "asymptomatic" smokers and that these can change with a harm reduction strategy.

Condition Intervention
Cigarette Smoker Drug: nicotine polacrilex Drug: nicotine transdermal system Drug: nicotine inhaler

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Biomarkers of Exposure and Host Response

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • exhaled breath hydrogen peroxide

Secondary Outcome Measures:
  • health status (SGRQ, CCQ, BCSS, LCQ)
  • lung function

Estimated Enrollment: 60
Study Start Date: December 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects must be 19 years of age or older
  • Have a stable smoking habit greater than three months
  • Have smoked for at least 5 pack years
  • Be willing to make a serious quit attempt and be willing to use nicotine replacement therapy
  • Be able to give informed consent

Exclusion Criteria:

  • regular use of anti-inflammatory medication; presence of any inflammatory *disease of the respiratory tract including moderate or worse COPD (FEV1 < 80% predicted and FEV1/FVC ratio < 0.7) or PFT criteria for asthma (improvement in FEV1>12% of predicted and >200ml).
  • Subjects with normal lung function who meet criteria for diagnosis of chronic bronchitis will be excluded.
  • Subjects with stable medical conditions, excluding inflammatory lung disease, will be permitted to participate, providing anti-inflammatory therapies are not used regularly and providing there has been no change in their clinical status in the two months prior to beginning the study.
  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): NCT00468234

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Institute for Science and Health
Principal Investigator: Stephen I Rennard, MD University of Nebraska
  More Information

ClinicalTrials.gov Identifier: NCT00468234     History of Changes
Other Study ID Numbers: 009-05
First Submitted: April 30, 2007
First Posted: May 2, 2007
Last Update Posted: January 5, 2010
Last Verified: December 2009

Keywords provided by University of Nebraska:
smoking cessation
harm reduction
exhaled breath condensate

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action