Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00493831 |
| Other study ID # |
0256-05-FB |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 23, 2005 |
| Est. completion date |
September 9, 2007 |
Study information
| Verified date |
August 2023 |
| Source |
University of Nebraska |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
