Analysis of Lipid Biomarkers of Exposure and Host Response

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: NCT00493831
Recruitment Status : Unknown
Verified June 2007 by University of Nebraska.
Recruitment status was:  Active, not recruiting
First Posted : June 28, 2007
Last Update Posted : June 28, 2007
Lorillard Tobacco Company
Information provided by:
University of Nebraska

Brief Summary:
The purpose of this prospective, open-label, clinical trial is to establish the feasibility and validity of exhaled breath condensate (EBC) biomarkers for use in studies designed to evaluate harm reduction strategies of smoking. This will be accomplished by measuring selected markers in EBC believed related to the pathogenesis of lung disease before and after a smoking cessation intervention.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Drug: nicotine polacrilex, transdermal system or inhaler Not Applicable

Detailed Description:

Twenty subjects will be accrued in three groups based on smoking habit: 10-20, 20-30 and >30 cigarettes/day. Eligibility criteria include male and female cigarette smokers ≥19 years of age, who are able to give informed consent, able to exhale into Eco Screen instrument for 15-20 minutes. All must be willing to make a serious quit attempt and be willing to use nicotine replacement therapy.

Subjects will be excluded if any of the following are present: 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). 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.

Upon entering into the study, subjects will establish a quit date and will be treated with nicotine replacement therapy (NRT) products based on individual preference and will receive smoking cessation counseling. They will then be seen at 12 visits over the course of 25 weeks.

Evaluations will include vital signs, interval smoking history, food frequency questionnaire, exhaled carbon monoxide, blood drawn for chemistry and CBC, peripheral blood harvested and serum aliquoted and saved for future biochemical analysis, urine sample for isoprostane, pregnancy test for females, and exhaled breath condensate. Some visits may also include spirometry with and with out bronchodilators, 24 hour urine collections for NNAL and NNAL-glc quantification, health status assessed using St. George’s Respiratory Questionnaire, the Functional Assessment of Chronic Illness Therapy – Fatigue, the Leicester Cough Questionnaire, the Clinical COPD Questionnaire and smoking related symptoms assessed using the Breathlessness, Cough, and Sputum Scale.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : May 2006
Estimated Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. lipid measures in EBC [ Time Frame: 12 weeks ]

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:   No

Inclusion Criteria:

  • Smoke at least 5 pack years
  • Have a stable smoking habit for 3 months
  • Be willing to make a serious quit attempt and
  • Be able to use nicotine replacement therapy

Exclusion Criteria:

  • Regular use of an anti-inflammatory medication
  • Presence of an inflammatory lung disease
  • Unstable medical condition

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): NCT00493831

Sponsors and Collaborators
University of Nebraska
Lorillard Tobacco Company
Principal Investigator: Stephen I Rennard, M.D. University of Nebraska Identifier: NCT00493831     History of Changes
Other Study ID Numbers: 265-05
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: June 28, 2007
Last Verified: June 2007

Keywords provided by University of Nebraska:
smoking reduction
harm reduction
lipid biomarkers

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