Validation of Biomarkers of Exposure and Host Response

NCT00468234 | Completed

• 1 other identifier: 009-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate biomarkers measured in exhaled breath condensate (EBC) to assess clinical strategies of harm reduction. It will take advantage of a recently developed device that permits collection of exhaled breath condensate reproducibly, with minimal subject effort and with no oral contamination. Samples from asymptomatic smokers before and after inducing a change in their smoking habit (cessation or reduction) with the aid of partial nicotine replacement.

Conditions

Cigarette Smoker

Keywords

smoking cessation; harm reduction; biomarker; exhaled breath condensate

Outcome Measures

Primary Outcomes (1)

• exhaled breath hydrogen peroxide

Secondary Outcomes (2)

• health status (SGRQ, CCQ, BCSS, LCQ)

• lung function

Interventions

nicotine polacrilex DRUG

Also known as: nicotine gum

nicotine transdermal system DRUG

Also known as: patch

nicotine inhaler DRUG

Also known as: nicotine oral inhaler

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• Institute for Science and Health: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Harm Reduction

Interventions

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

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Stephen I Rennard, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 30, 2007
• First Posted: May 2, 2007
• Study Start: December 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

US (1)