Analysis of Aldehyde Biomarkers of Exposure and Host Response

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Analysis of Aldehyde Biomarkers of Exposure and Host Response

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: nicotine polacrilex
* Drug: nicotine transdermal system
* Drug: nicotine inhaler


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine replacement therapy (NRT)<br>open label NRT self comparator design | Drug: nicotine polacrilex<br> <br> * Other names: Nicorette, gum, lozenge;Drug: nicotine transdermal system<br> <br> * Other names: patch;Drug: nicotine inhaler<br> <br> * Other names: Nicorette inhaler;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aldehyde Biomarkers | Aledhydes were assessed in exhaled breath condensate by mass spec and chemical assay. | Study was terminated at an interim analysis for futility | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, Biomarkers, Aldehydes, Exhaled breath, Harm Reduction, Cigarette smoking, cessation, reduction