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Validation of Biomarkers of Exposure and Host Response

This study has been completed.
Sponsor:
Collaborator:
Institute for Science and Health
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00468234
First received: April 30, 2007
Last updated: December 31, 2009
Last verified: December 2009
  Purpose

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: Open Label
Primary Purpose: Diagnostic
Official Title: Validation of Biomarkers of Exposure and Host Response

Resource links provided by NLM:


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)
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468234

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

No publications provided

ClinicalTrials.gov Identifier: NCT00468234     History of Changes
Other Study ID Numbers: 009-05
Study First Received: April 30, 2007
Last Updated: December 31, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014