Back to resultsA Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Loratadine (Claritin, BAY76-2211)
Sponsored by
About this trial
This is an interventional other trial for Allergic Rhinitis focused on measuring Allergy, Upper respiratory allergies
Eligibility Criteria
Inclusion Criteria:
- Female or male adults aged 18 to 65 years of age inclusive
- Were in good general health
- Previous self-reported sufferers of upper respiratory allergies who at the time of the study are either asymptomatic, symptomatic but not treating and agree to use study medication or symptomatic and treating with an allergy medicine that is not an antihistamine
- Agreed to not use antihistamine products 24 hours before and after the treatment
- Willing to avoid eating food or candy (other than crackers consumed during testing), drinking any liquid other than water, gum chewing and teeth brushing one hour prior to testing
Exclusion Criteria:
- Individuals who had used oral/systemic medications 24 hours before the first administration of test product
- Individuals who used medications which might influence taste perception
- Individuals who had received or used an investigational new drug in the last 30 days or had been an active participant in another clinical or market research study in the last 30 days
- Women who were pregnant or thinking of becoming pregnant or were nursing
- Participants with congestion at the time of study visit
- Any self-reported symptoms or conditions that might interfere with the participants ability to complete the evaluation of the product on testing day
- Any current medical condition that in the opinion of the Investigator or designee might interfere with normal taste and/or temperature perception (e.g., active common cold, sinus infection, bronchial infection, adenoids, paresthesia etc.)
- History of alcohol or drug abuse
- History of hypersensitivity or allergic reactions to any ingredients in the test product
- Individuals with a history of glaucoma, liver or kidney disease, respiratory conditions such as chronic bronchitis or swallowing difficulties
- Individuals who were currently wearing any kind of dental braces or with dental work or had cavities and associated pain that might affect their ability to chew a tablet
Sites / Locations
- Focus Pointe Global
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Loratadine chewable tablet
Arm Description
Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Outcomes
Primary Outcome Measures
Proportion of Participants With Agreement of Perception of Cooling Sensation
Participants were asked to response to question "the product provides a cooling sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.
Secondary Outcome Measures
Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location
Participants were asked to respond to question "the product provides a cooling sensation in the mouth, nose or throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.
Proportion of Participants With Agreement of Perception of Refreshing Sensation
Participants were asked to response to question "the product provides a refreshing sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.
Proportion of Participants With Agreement of the Refreshing of the Cooling Sensation
Participants were asked to response to question "the cooling sensation is refreshing" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the refreshing of the cooling sensation.
Proportion of Participants With Agreement of the Unique Sensory Experience for an Allergy Medicine
Participants were asked to response to question "the sensory experience is unique for an allergy medicine" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the unique sensory experience sensation.
Proportion of Participants With Agreement of Soothing Feeling on the Throat
Participants were asked to response to question "the product feels soothing on the throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the soothing feeling.
Proportion of Participants With Agreement of Liking the Flavor Sensation of the Product
Participants were asked to response to question "I like the flavor sensation of the product" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of liking the enjoyable flavor sensation.
Proportion of Participants With Agreement of the Enjoyable Product Experience
Participants were asked to response to question "the product experience was enjoyable" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the enjoyable experience.
Proportion of Participants With Agreement of the Great Taste of the Product
Participants were asked to response to question "the product tastes great" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the great taste.
Time to Perception of Cooling Sensation
The mean time point at which cooling was initially perceived was claimed as the onset of cooling. The mean onsets of cooling sensation in the mouth, nose and throat were reported.
Duration of Cooling Sensation
Participants who reported that they never experienced a cooling sensation were not included in the model. Those for whom the cooling sensation extended for 60 minutes or more were considered right-censored and were treated as such in the model. The median time of cooling sensation in the mouth, nose and throat was reported. Dispersion values were not calculated for this sensory study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04162795
Brief Title
A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies
Official Title
An Open Label, Multi-center Study to Evaluate Sensory Attributes of an Antihistamine Product
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
November 13, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, researchers were primarily interested in evaluating the level of agreement of cooling sensation provided by this chewable, flavored, allergy medicine. Participants joining this study received one test drug tablet and were asked to chew completely before swallowing the drug. A questionnaire was used to collect the feedback from participants. The study involved only one (1) visit and participant stayed in this study for about 60-75 minutes to evaluate the cooling sensation as well as other sensory attributes perceived in the mouth, nose and throat.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Allergy, Upper respiratory allergies
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Participants were blinded to product brand
Allocation
N/A
Enrollment
468 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loratadine chewable tablet
Arm Type
Experimental
Arm Description
Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Intervention Type
Drug
Intervention Name(s)
Loratadine (Claritin, BAY76-2211)
Intervention Description
Chewable tablet, oral, single dose
Primary Outcome Measure Information:
Title
Proportion of Participants With Agreement of Perception of Cooling Sensation
Description
Participants were asked to response to question "the product provides a cooling sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.
Time Frame
Up to 5 minutes post ingestion of study medication
Secondary Outcome Measure Information:
Title
Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location
Description
Participants were asked to respond to question "the product provides a cooling sensation in the mouth, nose or throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.
Time Frame
Up to 5 minutes post ingestion of study medication
Title
Proportion of Participants With Agreement of Perception of Refreshing Sensation
Description
Participants were asked to response to question "the product provides a refreshing sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.
Time Frame
Up to 5 minutes post ingestion of study medication
Title
Proportion of Participants With Agreement of the Refreshing of the Cooling Sensation
Description
Participants were asked to response to question "the cooling sensation is refreshing" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the refreshing of the cooling sensation.
Time Frame
Up to 5 minutes post ingestion of study medication
Title
Proportion of Participants With Agreement of the Unique Sensory Experience for an Allergy Medicine
Description
Participants were asked to response to question "the sensory experience is unique for an allergy medicine" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the unique sensory experience sensation.
Time Frame
Up to 5 minutes post ingestion of study medication
Title
Proportion of Participants With Agreement of Soothing Feeling on the Throat
Description
Participants were asked to response to question "the product feels soothing on the throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the soothing feeling.
Time Frame
Up to 5 minutes post ingestion of study medication
Title
Proportion of Participants With Agreement of Liking the Flavor Sensation of the Product
Description
Participants were asked to response to question "I like the flavor sensation of the product" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of liking the enjoyable flavor sensation.
Time Frame
Up to 5 minutes post ingestion of study medication
Title
Proportion of Participants With Agreement of the Enjoyable Product Experience
Description
Participants were asked to response to question "the product experience was enjoyable" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the enjoyable experience.
Time Frame
Up to 5 minutes post ingestion of study medication
Title
Proportion of Participants With Agreement of the Great Taste of the Product
Description
Participants were asked to response to question "the product tastes great" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the great taste.
Time Frame
Up to 5 minutes post ingestion of study medication
Title
Time to Perception of Cooling Sensation
Description
The mean time point at which cooling was initially perceived was claimed as the onset of cooling. The mean onsets of cooling sensation in the mouth, nose and throat were reported.
Time Frame
Up to 60 minutes post ingestion of study medication
Title
Duration of Cooling Sensation
Description
Participants who reported that they never experienced a cooling sensation were not included in the model. Those for whom the cooling sensation extended for 60 minutes or more were considered right-censored and were treated as such in the model. The median time of cooling sensation in the mouth, nose and throat was reported. Dispersion values were not calculated for this sensory study.
Time Frame
Up to 60 minutes post ingestion of study medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female or male adults aged 18 to 65 years of age inclusive
Were in good general health
Previous self-reported sufferers of upper respiratory allergies who at the time of the study are either asymptomatic, symptomatic but not treating and agree to use study medication or symptomatic and treating with an allergy medicine that is not an antihistamine
Agreed to not use antihistamine products 24 hours before and after the treatment
Willing to avoid eating food or candy (other than crackers consumed during testing), drinking any liquid other than water, gum chewing and teeth brushing one hour prior to testing
Exclusion Criteria:
Individuals who had used oral/systemic medications 24 hours before the first administration of test product
Individuals who used medications which might influence taste perception
Individuals who had received or used an investigational new drug in the last 30 days or had been an active participant in another clinical or market research study in the last 30 days
Women who were pregnant or thinking of becoming pregnant or were nursing
Participants with congestion at the time of study visit
Any self-reported symptoms or conditions that might interfere with the participants ability to complete the evaluation of the product on testing day
Any current medical condition that in the opinion of the Investigator or designee might interfere with normal taste and/or temperature perception (e.g., active common cold, sinus infection, bronchial infection, adenoids, paresthesia etc.)
History of alcohol or drug abuse
History of hypersensitivity or allergic reactions to any ingredients in the test product
Individuals with a history of glaucoma, liver or kidney disease, respiratory conditions such as chronic bronchitis or swallowing difficulties
Individuals who were currently wearing any kind of dental braces or with dental work or had cavities and associated pain that might affect their ability to chew a tablet
Facility Information:
Facility Name
Focus Pointe Global
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Learn more about this trial
A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies
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