Analysis of Lipid Biomarkers of Exposure and Host Response
Recruitment status was Active, not recruiting
|First Received Date ICMJE||June 5, 2007|
|Last Updated Date||June 27, 2007|
|Start Date ICMJE||May 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||lipid measures in EBC [ Time Frame: 12 weeks ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00493831 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Analysis of Lipid Biomarkers of Exposure and Host Response|
|Official Title ICMJE||Not Provided|
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Condition ICMJE||Cigarette Smoking|
|Intervention ICMJE||Drug: nicotine polacrilex, transdermal system or inhaler|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Completion Date||July 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||19 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00493831|
|Other Study ID Numbers ICMJE||265-05|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Nebraska|
|Collaborators ICMJE||Lorillard Tobacco Company|
|Information Provided By||University of Nebraska|
|Verification Date||June 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP