Analysis of Aldehyde Biomarkers of Exposure and Host Response

NCT00482690 | Terminated Results

• 1 other identifier: 0257-05-FB
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Analysis of aldeyde biomarkers of exposure and host response 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

Smoking Cessation

Keywords

Smoking cessation; Biomarkers; Aldehydes; Exhaled breath; Harm Reduction; Cigarette smoking; cessation; reduction

Outcome Measures

Primary Outcomes (1)

• Aldehyde Biomarkers

  Aledhydes were assessed in exhaled breath condensate by mass spec and chemical assay.

  Study was terminated at an interim analysis for futility

Study Arms (1)

Nicotine replacement therapy (NRT)

EXPERIMENTAL

open label NRT self comparator design

Drug: nicotine polacrilex; Drug: nicotine transdermal system; Drug: nicotine inhaler

Interventions

nicotine polacrilex DRUG

Also known as: Nicorette, gum, lozenge

Nicotine replacement therapy (NRT)

nicotine transdermal system DRUG

Also known as: patch

Nicotine replacement therapy (NRT)

nicotine inhaler DRUG

Also known as: Nicorette inhaler

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:

• Smokers of at least 5 pack years;
• Stable smoking habit for 3 months;
• Willing to make a serious quit attempt;
• Able to use nicotine replacement therapy

You may not qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead
• R.J. Reynolds Tobacco Company: collaborator

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Harm Reduction; Cigarette Smoking

Interventions

Tobacco Use Cessation Devices; Nicotine Chewing Gum; Chewing Gum; Transdermal Patch; Nicotine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Smoking; Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Exudates; Biological Products; Complex Mixtures; Equipment and Supplies; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

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: No
• 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 1, 2007
• First Posted: June 5, 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 2, 2023

Record last verified: 2023-08

Locations

US (1)