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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Loratadine (Claritin, BAY76-2211)

• Study Type: Interventional
• Enrollment (Actual): 468
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Focus Pointe Global

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 5 minutes post ingestion of study medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	Up to 60 minutes post ingestion of study medication
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.	Up to 60 minutes post ingestion of study medication

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): November 13, 2019
• Study Completion (Actual): November 13, 2019

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Allergy; Upper respiratory allergies
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Loratadine
• Other Study ID Numbers: 21048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD 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.

Drug and device information, study documents

• 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