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

Bayer

Status and phase: Completed; Phase 4

Conditions: Allergic Rhinitis

Treatments: Drug: Loratadine (Claritin, BAY76-2211)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04162795

21048

Details and patient eligibility

About

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.

Enrollment: 468 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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468 participants in 1 patient group

Loratadine chewable tablet

Experimental group

Description:

Participants received one dose of loratadine chewable tablet to chew completely before swallowing.

Treatment:

Drug: Loratadine (Claritin, BAY76-2211)