Status:
COMPLETED
Validation of Biomarkers of Exposure and Host Response
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
Institute for Science and Health
Conditions:
Cigarette Smoker
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
This study will evaluate biomarkers measured in exhaled breath condensate (EBC) to assess clinical strategies of harm reduction. It will take advantage of a recently developed device that permits coll...
Detailed Description
The proposed study will evaluate biomarkers measured in exhaled breath condensate (EBC) for the purpose of assessing clinical strategies of harm reduction. It will take advantage of a recently develop...
Eligibility Criteria
Inclusion
- Subjects must be 19 years of age or older
- Have a stable smoking habit greater than three months
- Have smoked for at least 5 pack years
- Be willing to make a serious quit attempt and be willing to use nicotine replacement therapy
- Be able to give informed consent
Exclusion
- 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) or PFT criteria for asthma (improvement in FEV1\>12% of predicted and \>200ml).
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00468234
Start Date
December 1 2005
End Date
September 1 2007
Last Update
August 31 2023
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198