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Completed

NCT Number: NCT04162795

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Focus Pointe Global

Teaneck, New Jersey, 07666, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loratadine (Claritin, BAY76-2211)

Drug

Chewable tablet, oral, single dose

Primary outcomes

  1. Proportion of Participants With Agreement of Perception of Cooling Sensation

    Time frame: 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 outcomes

  1. Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2019
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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