Cough Sensitivity and Taste Preferences

Smoking Clinical Trial

— CAP  

Official title:

Cough and Taste Preferences in Adolescents and Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399060
• Other study ID #: 812923
• Secondary ID: SAP No. 41000548
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: October 23, 2013
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: October 2013
• Source: Monell Chemical Senses Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years and older

Eligibility

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).

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Smoking

Locations

Country	Name	City	State
United States	Monell Chemical Senses Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Monell Chemical Senses Center	Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	smoking history (of parents)	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	10 minutes	No
Secondary	Genotype	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	One year	No