Analysis of Aldehyde Biomarkers of Exposure and Host Response

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by University of Nebraska.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
R.J. Reynolds Tobacco Company
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00482690
First received: June 1, 2007
Last updated: June 4, 2007
Last verified: June 2007

June 1, 2007
June 4, 2007
March 2006
Not Provided
Aldehyde biomarkers
Same as current
Complete list of historical versions of study NCT00482690 on ClinicalTrials.gov Archive Site
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Analysis of Aldehyde Biomarkers of Exposure and Host Response
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Analysis of aldeyde biomarkers of exposure and host response 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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Smoking Cessation
  • Drug: nicotine polacrilex
  • Drug: nicotine transdermal system
  • Drug: nicotine inhaler
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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July 2007
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Inclusion Criteria:

  • Smokers of at least 5 pack years;
  • Stable smoking habit for 3 months;
  • Willing to make a serious quit attempt;
  • Able to use nicotine replacement therapy

Exclusion Criteria:

  • Regular use of anti-inflammatory medication
  • Inflammatory lung disease
  • Unstable medical condition
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00482690
257-05
No
Not Provided
University of Nebraska
R.J. Reynolds Tobacco Company
Principal Investigator: Stephen I Rennard University of Nebraska
University of Nebraska
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP