Analysis of Aldehyde Biomarkers of Exposure and Host Response

Not Applicable

Terminated

Conditions: Smoking Cessation

Interventions: Drug: nicotine polacrilex
Drug: nicotine transdermal system
Drug: nicotine inhaler

Registration Number: NCT00482690

Lead Sponsor: University of Nebraska

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nicotine replacement therapy (NRT)	nicotine transdermal system	open label NRT self comparator design
Nicotine replacement therapy (NRT)	nicotine polacrilex	open label NRT self comparator design
Nicotine replacement therapy (NRT)	nicotine inhaler	open label NRT self comparator design

Primary Outcome Measures

Name	Time	Method
Aldehyde Biomarkers	Study was terminated at an interim analysis for futility	Aledhydes were assessed in exhaled breath condensate by mass spec and chemical assay.

Secondary Outcome Measures