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CAP: Cough Sensitivity and Taste Preferences

Sponsor
Monell Chemical Senses Center (Other)
Overall Status
Completed
CT.gov ID
NCT01399060
Collaborator
Pennsylvania Department of Health (Other)
80
Enrollment
1
Location
8
Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This single-site, within-subject, experimental study is designed to test the hypothesis children who live in a household in which one or both of their parent smoke will exhibit a higher cough threshold and will prefer more intense sweet tastes than children who live in a household where neither parent smokes. Subjects will include at least 50 racially and ethnically diverse, healthy children aged 10 to 17 years (a critical time for experimenting with tobacco) and a parent. The sample will comprise two groups: Non-Environmental Tobacco Smoke (ETS) Exposed (neither the child nor parents has ever smoked or been exposed to environmental tobacco smoke (ETS) in the home), and ETS-Exposed (the parent has smoked at least 3 cigarettes per day for at least five years in the home, with the child living in the home continuously). Cough sensitivity will be measured using a standard single-inhalation challenge, a test of the minimum concentration of capsaicin (the spicy chemical in hot peppers) needed to elicit cough. Sweet taste preferences will be measured using a forced-choice paired comparison method of liquids which differ in sucrose content. Measures of breath carbon monoxide will validate the smoking status of parents and their adolescent children. The key comparison will be between Non-ETS Exposed and ETS-Exposed children, with the difference between smoking and non-smoking parents as a positive control. Because smoking and non-smoking families may differ in ways besides tobacco exposure, the investigators will obtain health histories (with a focus on respiratory illness), smoking histories, measures of body weight, diet, and responses to personality tests (including susceptibility to addiction). The investigators will also obtain genomic DNA from saliva samples. Genes for chemosensory receptors that are part of the cough reflex pathway and genotype may account for aspects of cough sensitivity.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Cough and Taste Preferences in Adolescents and Adults
    Study Start Date :
    Apr 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2011
    Actual Study Completion Date :
    Dec 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. cough threshold [90 minutes]

      Cough threshold (sensitivity) will be measured using a standard single-inhalation challenge, a test of the minimum concentration of capsaicin (the spicy chemical in hot peppers) needed to elicit cough

    Secondary Outcome Measures

    1. smoking history (of parents) [10 minutes]

      We will determine the smoking history of the parent via questionnaires to examine the relationship between cough threshold and smoking history of parent for both children and parent

    2. Genotype [One year]

      We will genotype saliva samples for genes for chemosensory receptors that are part of the cough reflex pathway and genotype to explore individual differences in cough sensitivity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy adults and children of both genders will be studied.

    • Ages of children will range from 10 to 17 years.

    Exclusion Criteria:

    • Subjects with a current respiratory illness of any type (including current infection or infection within the last month, asthma, chronic obstructive pulmonary disease, bronchitis of any type, or any other breathing issue).

    • Subjects who report that they have a history of asthma or other chronic respiratory condition.

    • Subjects who report unusual sensitivity to environmental odors (e.g., reactive airways, multiple chemical sensitivity).

    • Subjects who report that they have a history or allergic reactions to foods and/or chemicals.

    • Subject who report that they are diabetic, or on any medication, with exception of birth control pills (for mothers only).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Monell Chemical Senses Center Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Monell Chemical Senses Center
    • Pennsylvania Department of Health

    Investigators

    • Principal Investigator: Julie A. Mennella, PhD, Monell Chemical Senses Center
    • Principal Investigator: Paul Wise, PhD, Monell Chemical Senses Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Julie A. Mennella, Member, Monell Chemical Senses Center
    ClinicalTrials.gov Identifier:
    NCT01399060
    Other Study ID Numbers:
    • 812923
    • SAP No. 4100054860
    First Posted:
    Jul 21, 2011
    Last Update Posted:
    Oct 24, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Julie A. Mennella, Member, Monell Chemical Senses Center
    Cough
    tobacco smoke exposure
    Additional relevant MeSH terms:
    Cough

    Study Results

    No Results Posted as of Oct 24, 2013