A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)
Condition: Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: loratadine; fexofenadine; placebo to loratadine; placebo to fexofenadine
Intervention description: loratadine, one 10 mg tablet, orally; fexofenadine, one 180 mg tablet, orally; one tablet, orally; one tablet, orally
Intervention MeSH terms: Loratadine; Fexofenadine; Terfenadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the onset of action of two commercially available
      over-the-counter antihistamines (Loratadine and

      Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo
      sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research
      Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom
      Complex (MSC) score will then receive drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants of child bearing potential must demonstrate a negative

        urine pregnancy test at Screening (Visit 1) and Visit 4 (prior to randomization) and agree
        to use (and/or have their partner use) 2 acceptable methods of birth control beginning at
        the Screening visit and throughout the study.

          -  Willing to stop use of current decongestant and allergy medications at the start of
             the washout period (Visit 1) and during the trial.

          -  Documented history or participant-reported history of seasonal allergic rhinitis
             caused by mountain cedar pollen within the last 2 years and documented or
             participant-reported symptoms over at least the last 2 mountain cedar allergy seasons.

          -  Documented skin testing (prick with wheal ≥ 4 mm larger than the diluent) within the
             last 1 year to mountain cedar pollen present.

          -  Capable of reading English.

          -  Body mass index (BMI) <35.

        Exclusion Criteria:

          -  Any significant medical condition which, in the judgment of the investigator, is a
             contraindication to the use of loratadine, fexofenadine or might interfere with the
             trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism),
             uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease,
             elevated intraocular pressure, prostatic hypertrophy.

          -  Have started allergen immunotherapy within 1 month preceding enrollment or
             participants starting allergen immunotherapy or anticipating immunotherapy dose change
             during the trial. Xolair (omalizumab) may not be used within 4 years prior to trial
             participation.

          -  Known allergy or intolerance to loratadine, desloratadine, or fexofenadine.

          -  History of rhinitis medicamentosa.

          -  Use of systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone
             is permitted), or nasal corticosteroids in the last 30 days or current or expected use
             of disallowed medications as listed in the protocol.

          -  Asthma, with the exception of mild intermittent asthma.