Cough Sensitivity and Taste Preferences (CAP)

This study has been completed.
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
Julie A. Mennella, Monell Chemical Senses Center
ClinicalTrials.gov Identifier:
NCT01399060
First received: July 19, 2011
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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
Smoking

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Cough and Taste Preferences in Adolescents and Adults

Resource links provided by NLM:


Further study details as provided by Monell Chemical Senses Center:

Primary Outcome Measures:
  • cough threshold [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    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:
  • smoking history (of parents) [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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

  • Genotype [ Time Frame: One year ] [ Designated as safety issue: No ]
    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


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.


Enrollment: 80
Study Start Date: April 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399060

Locations
United States, Pennsylvania
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
  More Information

Publications:
Responsible Party: Julie A. Mennella, Member, Monell Chemical Senses Center
ClinicalTrials.gov Identifier: NCT01399060     History of Changes
Other Study ID Numbers: 812923, SAP No. 4100054860
Study First Received: July 19, 2011
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Monell Chemical Senses Center:
Cough
tobacco smoke exposure

ClinicalTrials.gov processed this record on August 28, 2014