SmokingCAPNCT01399060
Cough Sensitivity and Taste Preferences
An observational study of Smoking, run by Monell Chemical Senses Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Healthy adults and children of both genders will be studied.
- Ages of children will range from 10 to 17 years.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Monell Chemical Senses Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Conditions
- Smoking
- Keywords
- Cough, tobacco smoke exposure
- Medical subject headings
- Smoking, Cough
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 minutes
Secondary outcomes (2)
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
Measured: 10 minutes
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monell Chemical Senses Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Principal investigator, Julie A. Mennella, Monell Chemical Senses Center
- Investigators
- Julie A. Mennella, PhD, Principal investigator, Monell Chemical Senses CenterPaul Wise, PhD, Principal investigator, Monell Chemical Senses Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399060
- Sponsor's protocol ID
- 812923
- Other IDs
- SAP No. 4100054860
- Acronym
- CAP
- Status last verified
- Oct 2013
- First submitted
- 19 Jul 2011
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22904107
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cough and Taste Preferences in Adolescents and Adults
- ClinicalTrials.gov ID
- NCT01399060
- Acronym / sponsor ID
- CAP / 812923
- Conditions
- Smoking
- Keywords
- Cough, tobacco smoke exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Monell Chemical Senses CenterUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Healthy adults and children of both genders will be studied.
- Ages of children will range from 10 to 17 years.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cough threshold
Time frame: 90 minutes
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
2 secondary outcomes
smoking history (of parents)
Time frame: 10 minutes
Genotype
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2013.
- Results publication: PubMed 22904107Wise 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A. Mennella, PhD principal investigator
Monell Chemical Senses Center
Paul Wise, PhD principal investigator
Monell Chemical Senses Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by Monell Chemical Senses Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cough threshold (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01399060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2013.