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Cough Sensitivity and Taste Preferences

NCT ID: NCT01399060

Last Updated: 2013-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking

Keywords

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Cough tobacco smoke exposure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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).
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pennsylvania Department of Health

OTHER_GOV

Sponsor Role collaborator

Monell Chemical Senses Center

OTHER

Sponsor Role lead

Responsible Party

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Julie A. Mennella

Member

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie A. Mennella, PhD

Role: PRINCIPAL_INVESTIGATOR

Monell Chemical Senses Center

Paul Wise, PhD

Role: PRINCIPAL_INVESTIGATOR

Monell Chemical Senses Center

Locations

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Monell Chemical Senses Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Wise PM, Mennella JA, Finkbeiner S. Impaired cough sensitivity in children of smokers. Nicotine Tob Res. 2013 Feb;15(2):603-7. doi: 10.1093/ntr/nts198. Epub 2012 Aug 17.

Reference Type RESULT
PMID: 22904107 (View on PubMed)

Other Identifiers

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SAP No. 4100054860

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

812923

Identifier Type: -

Identifier Source: org_study_id