Study Completed

Allergic Rhinitis

Bayer Identifier:

21048

ClinicalTrials.gov Identifier:

NCT04162795

EudraCT Number:

Not Available

EU CT Number:

Not Available

A study to evaluate cooling sensation of an allergy product in adults with a history of allergies

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 65 Years

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

Trial summary

Enrollment Goal

468

Trial Dates

November 2019 - November 2019

Phase

Phase 4

Could I Receive a placebo

Products

CLARITIN (Loratadine, BAY76-2211)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Focus Pointe Global	Teaneck, 07666, United States

Primary Outcome

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.
Time Frame:
Up to 5 minutes post ingestion of study medication

Secondary Outcome

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.
Time Frame:
Up to 5 minutes post ingestion of study medication
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.
Time Frame:
Up to 5 minutes post ingestion of study medication
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.
Time Frame:
Up to 5 minutes post ingestion of study medication
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.
Time Frame:
Up to 5 minutes post ingestion of study medication
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.
Time Frame:
Up to 5 minutes post ingestion of study medication
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.
Time Frame:
Up to 5 minutes post ingestion of study medication
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.
Time Frame:
Up to 5 minutes post ingestion of study medication
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 Frame:
Up to 5 minutes post ingestion of study medication
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.
Time Frame:
Up to 60 minutes post ingestion of study medication
Duration of cooling sensation
The median time of cooling sensation in the mouth, nose and throat was reported. 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.
Time Frame:
Up to 60 minutes post ingestion of study medication

Trial design

An open label, multi-center study to evaluate sensory attributes of an antihistamine product

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

N/A

Blinding

N/A

Assignment

Single Group Assignment

Trial Arms