Analysis of Lipid Biomarkers of Exposure and Host Response

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by University of Nebraska.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Lorillard Tobacco Company
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00493831
First received: June 5, 2007
Last updated: June 27, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention
Cigarette Smoking
Drug: nicotine polacrilex, transdermal system or inhaler

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • lipid measures in EBC [ Time Frame: 12 weeks ]

Enrollment: 20
Study Start Date: May 2006
Estimated Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smoke at least 5 pack years
  • Have a stable smoking habit for 3 months
  • Be willing to make a serious quit attempt and
  • Be able to use nicotine replacement therapy

Exclusion Criteria:

  • Regular use of an anti-inflammatory medication
  • Presence of an inflammatory lung disease
  • Unstable medical condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493831

Sponsors and Collaborators
University of Nebraska
Lorillard Tobacco Company
Investigators
Principal Investigator: Stephen I Rennard, M.D. University of Nebraska
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00493831     History of Changes
Other Study ID Numbers: 265-05
Study First Received: June 5, 2007
Last Updated: June 27, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
smoking reduction
inflammation
harm reduction
lipid biomarkers

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014