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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00468234 |
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Date of registration:
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30/04/2007 |
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Primary sponsor: |
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Public title:
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Validation of Biomarkers of Exposure and Host Response
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Scientific title:
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Validation of Biomarkers of Exposure and Host Response |
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Date of first enrolment:
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December 2005 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00468234 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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United States
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Contacts
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Name:
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Stephen I Rennard, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Nebraska |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cigarette Smoker
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Intervention(s)
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Drug: nicotine inhaler
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Drug: nicotine polacrilex
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Drug: nicotine transdermal system
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Primary Outcome(s)
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exhaled breath hydrogen peroxide
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Secondary Outcome(s)
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health status (SGRQ, CCQ, BCSS, LCQ)
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lung function
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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