A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies

An Open Label, Multi-center Study to Evaluate Sensory Attributes of an Antihistamine Product

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04162795

Enrollment

468

Registered

2019-11-14

Start date

2019-11-12

Completion date

2019-11-13

Last updated

2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Allergy, Upper respiratory allergies

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.

Interventions

DRUGLoratadine (Claritin, BAY76-2211)

Chewable tablet, oral, single dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Masking description

Participants were blinded to product brand

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of Participants With Agreement of Perception of Cooling Sensation	Up to 5 minutes post ingestion of study medication	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

Measure	Time frame	Description
Proportion of Participants With Agreement of Perception of Refreshing Sensation	Up to 5 minutes post ingestion of study medication	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	Up to 5 minutes post ingestion of study medication	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	Up to 5 minutes post ingestion of study medication	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	Up to 5 minutes post ingestion of study medication	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 Perception of Cooling Sensation Per Location	Up to 5 minutes post ingestion of study medication	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 the Enjoyable Product Experience	Up to 5 minutes post ingestion of study medication	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	Up to 5 minutes post ingestion of study medication	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	Up to 60 minutes post ingestion of study medication	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	Up to 60 minutes post ingestion of study medication	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.
Proportion of Participants With Agreement of Liking the Flavor Sensation of the Product	Up to 5 minutes post ingestion of study medication	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.

Countries

United States

Participant flow

Recruitment details

Study was conducted at multiple centers in the US between 12 November 2019 (first participant first visit) and 13 November 2019 (last participant last visit).

Pre-assignment details

Overall, 468 participants were screened. Of them, 10 participants were screen failures and 16 participants did not complete the study with early termination. 442 participants received study treatment and completed the study.

Participants by arm

Arm	Count
Loratadine Chewable Tablet Participants received one dose of loratadine chewable tablet to chew completely before swallowing.	442
Total	442

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Other	16
Overall Study	Screen failures	10

Baseline characteristics

Characteristic	Loratadine Chewable Tablet
Age, Customized 18- 34 years	30 Percentage of participants
Age, Customized 35- 44 years	30 Percentage of participants
Age, Customized 45- 54 years	26 Percentage of participants
Age, Customized 55+ years	14 Percentage of participants
Race/Ethnicity, Customized Asian	5 Percentage of participants
Race/Ethnicity, Customized Black/African American	33 Percentage of participants
Race/Ethnicity, Customized Hispanic	12 Percentage of participants
Race/Ethnicity, Customized Other races	2 Percentage of participants
Race/Ethnicity, Customized White	52 Percentage of participants
Sex/Gender, Customized Female	54 Percentage of participants
Sex/Gender, Customized Male	46 Percentage of participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 442
other Total, other adverse events	9 / 442
serious Total, serious adverse events	0 / 442

Outcome results

Primary

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