Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482690
Status:
TERMINATED
Last Update Posted:
2023-09-07
First Post:
2007-06-01
Brief Title:
Analysis of Aldehyde Biomarkers of Exposure and Host Response
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Analysis of Aldehyde Biomarkers of Exposure and Host Response
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
primary analyses found unfeasible
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cigarettesday 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 FEV1FVC ratio 07 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 Georges 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
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 FEV1FVC ratio 07 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 Georges 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None