Clinical trial NCT01399060: Cough Sensitivity and Taste Preferences
Official title: Cough and Taste Preferences in Adolescents and Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Keywords: Cough
tobacco smoke exposure
Lead sponsor: Monell Chemical Senses Center
Sponsor class: OTHER
Collaborators: name: Pennsylvania Department of Health
First posted: 2011-07-21
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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).

Primary outcomes:
measure: cough threshold
timeFrame: 90 minutes
Secondary outcomes:
measure: smoking history (of parents)
timeFrame: 10 minutes
measure: Genotype
timeFrame: One year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Monell Chemical Senses Center
state: Pennsylvania
Study officials:
affiliation: Monell Chemical Senses Center
name: Julie A. Mennella, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Monell Chemical Senses Center
name: Paul Wise, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.