Analysis of Lipid Biomarkers of Exposure and Host Response

NCT00493831 | Terminated Results

• 1 other identifier: 0256-05-FB
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cigarette Smoking

Keywords

smoking reduction; inflammation; harm reduction; lipid biomarkers

Outcome Measures

Primary Outcomes (1)

• Lipid Measures in EBC

  No data were collected

  12 weeks

Study Arms (1)

Nicotine replacement therapy (NRT)

EXPERIMENTAL

any form of nicotine replacement would be allowed at subject discretion

Drug: nicotine polacrilex, transdermal system or inhaler

Interventions

nicotine polacrilex, transdermal system or inhaler DRUG

on label use of Nicotine replacement therapy (NRT)

Also known as: Nicotine replacement therapy

Nicotine replacement therapy (NRT)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Regular use of an anti-inflammatory medication
• Presence of an inflammatory lung disease
• Unstable medical condition

Sponsors & Collaborators

• University of Nebraska: lead
• Lorillard Tobacco Company: collaborator

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Smoking Reduction; Inflammation; Harm Reduction

Interventions

Tobacco Use Cessation Devices; Transdermal Patch; Nebulizers and Vaporizers; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Equipment and Supplies; Drug Therapy

Limitations and Caveats

The exhaled breath condensates did not contain sufficient lipids to permit evaluation above limits of detectability

Results Point of Contact

• Title: Stephen Rennard
• Organization: University of Nebraska Medical Center

srennard@unmc.edu

402-559-7313

Study Officials

• Stephen I Rennard, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2007
• First Posted: June 28, 2007
• Study Start: August 23, 2005
• Primary Completion: September 9, 2007
• Study Completion: September 9, 2007
• Last Updated: September 7, 2023
• Results First Posted: February 10, 2023

Record last verified: 2023-08

Locations

US (1)