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

NCT04162795 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 21048
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

Allergy; Upper respiratory allergies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location

  Up to 5 minutes post ingestion of study medication

• Proportion of Participants With Agreement of Perception of Refreshing Sensation

  Up to 5 minutes post ingestion of study medication

• Proportion of Participants With 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

  Up to 5 minutes post ingestion of study medication

• Proportion of Participants With Agreement of Soothing Feeling on the Throat

  Up to 5 minutes post ingestion of study medication

Study Arms (1)

Loratadine chewable tablet

EXPERIMENTAL

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

Drug: Loratadine (Claritin, BAY76-2211)

Interventions

Loratadine (Claritin, BAY76-2211) DRUG

Chewable tablet, oral, single dose

Loratadine chewable tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Focus Pointe Global

Teaneck, New Jersey, 07666, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Hypersensitivity

Interventions

Loratadine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

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

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Participants were blinded to product brand
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 14, 2019
• Study Start: November 12, 2019
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: February 4, 2021
• Results First Posted: February 4, 2021

Record last verified: 2021-01

Locations

US (1)