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

July 19, 2011
October 23, 2013
April 2011
December 2011   (final data collection date for primary outcome measure)
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
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 capsaisin (the spicy chemical in hot peppers) needed to elicit cough
Complete list of historical versions of study NCT01399060 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Cough Sensitivity and Taste Preferences
Cough and Taste Preferences in Adolescents and Adults

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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.

Smoking
Not Provided
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2011
December 2011   (final data collection date for primary outcome measure)

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).
Both
10 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01399060
812923, SAP No. 4100054860
No
Julie A. Mennella, Monell Chemical Senses Center
Monell Chemical Senses Center
Pennsylvania Department of Health
Principal Investigator: Julie A. Mennella, PhD Monell Chemical Senses Center
Principal Investigator: Paul Wise, PhD Monell Chemical Senses Center
Monell Chemical Senses Center
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP