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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04162795
• Collaborator: (none)
• Enrollment: 468
• Location: 1
• Arm: 1
• Actual Duration (Days): 1
• Patients Per Site Per Month: 14244.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Drug: Loratadine (Claritin, BAY76-2211)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 468 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Participants were blinded to product brand
• Primary Purpose: Other
• Official Title: An Open Label, Multi-center Study to Evaluate Sensory Attributes of an Antihistamine Product
• Actual Study Start Date: Nov 12, 2019
• Actual Primary Completion Date: Nov 13, 2019
• Actual Study Completion Date: Nov 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Loratadine chewable tablet Participants received one dose of loratadine chewable tablet to chew completely before swallowing.	Drug: Loratadine (Claritin, BAY76-2211); Chewable tablet, oral, single dose

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Focus Pointe Global	Teaneck	New Jersey	United States	07666

Sponsors and Collaborators

• Bayer

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 21, 2019

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT04162795
• Other Study ID Numbers: 21048
• First Posted: Nov 14, 2019
• Last Update Posted: Feb 4, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by Bayer: Allergy; Upper respiratory allergies
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Loratadine

Study Results

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 Detail	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.

Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Period Title: Overall Study
STARTED	468
COMPLETED	442
NOT COMPLETED	26

Baseline Characteristics

Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Overall Participants	442
Age, Customized (Percentage of participants) [Number]
18- 34 years	30 6.8%
35- 44 years	30 6.8%
45- 54 years	26 5.9%
55+ years	14 3.2%
Sex/Gender, Customized (Percentage of participants) [Number]
Male	46 10.4%
Female	54 12.2%
Race/Ethnicity, Customized (Percentage of participants) [Number]
White	52 11.8%
Black/African American	33 7.5%
Hispanic	12 2.7%
Asian	5 1.1%
Other races	2 0.5%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who received the study medication and had an evaluation data for study medication

Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Measure Participants	442
Number (95% Confidence Interval) [Proportion of participants]	0.99 0.2%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who received the study medication and had an evaluation data for study medication

Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Measure Participants	442
Cooling in Mouth	0.99 0.2%
Cooling in Nose	0.71 0.2%
Cooling in Throat	0.93 0.2%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who received the study medication and had an evaluation data for study medication

Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Measure Participants	442
Refreshing	0.96 0.2%
...Refreshing in Mouth	0.96 0.2%
...Refreshing in Nose	0.61 0.1%
...Refreshing in Throat	0.88 0.2%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who received the study medication and had an evaluation data for study medication

Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Measure Participants	442
Number (95% Confidence Interval) [Proportion of participants]	0.96 0.2%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who received the study medication and had an evaluation data for study medication

Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Measure Participants	442
Number (95% Confidence Interval) [Proportion of participants]	0.94 0.2%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who received the study medication and had an evaluation data for study medication

Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Measure Participants	442
Number (95% Confidence Interval) [Proportion of participants]	0.89 0.2%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who received the study medication and had an evaluation data for study medication

Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Measure Participants	442
Number (95% Confidence Interval) [Proportion of participants]	0.87 0.2%

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who received the study medication and had an evaluation data for study medication

Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Measure Participants	442
Number (95% Confidence Interval) [Proportion of participants]	0.85 0.2%

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who received the study medication and had an evaluation data for study medication

Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Measure Participants	442
Number (95% Confidence Interval) [Proportion of participants]	0.77 0.2%

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who received the study medication and had an evaluation data for study medication

Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Measure Participants	442
Cooling in Mouth	5.82
Cooling in Nose	14.97
Cooling in Throat	16.17

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants who received the study medication and had an evaluation data for study medication

Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
Measure Participants	442
Cooling in Mouth	20
Cooling in Nose	20
Cooling in the Throat	15

Adverse Events

Time Frame	From the signing of the informed consent form (ICF) until discharge from the study site (1 day)
Arm/Group Title	Loratadine Chewable Tablet
Arm/Group Description	Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
All Cause Mortality
	Loratadine Chewable Tablet
	Affected / at Risk (%)	# Events
Total	0/442 (0%)
Serious Adverse Events
	Loratadine Chewable Tablet
	Affected / at Risk (%)	# Events
Total	0/442 (0%)
Other (Not Including Serious) Adverse Events
	Loratadine Chewable Tablet
	Affected / at Risk (%)	# Events
Total	9/442 (2%)
Eye disorders
Ocular sensory symptom	1/442 (0.2%)
Gastrointestinal disorders
Vomiting	1/442 (0.2%)
Salivary duct inflammation	1/442 (0.2%)
Dyspepsia	2/442 (0.5%)
Infections and infestations
Rhinitis	1/442 (0.2%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	1/442 (0.2%)
Laryngeal inflammation	2/442 (0.5%)
Rhinorrhea	1/442 (0.2%)

Limitations/Caveats

Kaplan-Meier Estimates of the duration of the cooling sensation were not able to be reported in this data set.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.