A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Loratadine (Claritin, BAY76-2211)
Intervention description: Chewable tablet, oral, single dose
Intervention MeSH terms: Loratadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Participants were blinded to product brand
Enrollment: 468.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Allergy; Upper respiratory allergies

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.
    

Eligibility criteria:

        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