Cough Sensitivity and Taste Preferences

NCT01399060 | Completed

• 2 other identifiers: 812923SAP No. 4100054860
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

Cough; tobacco smoke exposure

Outcome Measures

Primary Outcomes (1)

• cough threshold

  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

  90 minutes

Secondary Outcomes (2)

• smoking history (of parents)

  10 minutes

• Genotype

  One year

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 50 parent-child dyads (N=100 subjects total) will be tested on two days separated by at least 2-3 days. The children will be between the ages of 10 and 17 years. Half of sample will be children whose mothers are current smokers and the other have will be children whose mothers and fathers never smoked in their lifetimes.

You may qualify if:

• Healthy adults and children of both genders will be studied.
• Ages of children will range from 10 to 17 years.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Monell Chemical Senses Center: lead
• Pennsylvania Department of Health: collaborator

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 22904107 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples will be obtained from the subjects, if consented. These saliva samples will be genotyped at the Monell Center for genes that may play a role in chemical irritation and flavor-perception. This testing is exploratory in nature.

MeSH Terms

Conditions

Smoking; Cough

Condition Hierarchy (Ancestors)

Behavior; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie A. Mennella, PhD

  Monell Chemical Senses Center

  PRINCIPAL INVESTIGATOR

• Paul Wise, PhD

  Monell Chemical Senses Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Member

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 21, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 24, 2013

Record last verified: 2013-10

Locations

US (1)