Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)
Condition: Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial
Intervention: 5-mg Desloratadine; Placebo
Intervention description: 5-mg Desloratadine tablet, once daily for 15 days; Placebo tablet, once daily for 15 days
Intervention MeSH terms: Desloratadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 547.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Allergic Rhinitis; Intermittent Allergic Rhinitis

Summary:

      This study will investigate the effectiveness of desloratadine in treating subjects with
      allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

        The subject must meet ALL of the criteria listed below for entry:

          -  For this study, the diagnosis of IAR is not based solely on the current episode of AR.
             Subjects must have at least a 2 year history of AR consistent with IAR (defined as
             symptoms of allergic rhinitis present less than four days per week or for less than
             four consecutive weeks per year); the current episode can count as the second year.

          -  Subjects must be 12 years of age and older, of either sex and of any race.

          -  At the Run-In Visit, subjects must be sufficiently symptomatic, with a T5SS 12-hour
             AM-PRIOR (reflective) symptoms severity score of at least 6.

          -  In order for a subject to qualify at the Baseline Visit, the sum of the daily averages
             of the diary recordings of the 12-hour AM PRIOR + PM-PRIOR (reflective) T5SS collected
             during Days -4 to -1 and the AM PRIOR T5SS on the morning of the Baseline Visit (Day
             1) must be >= 30.

          -  Subjects must have a positive skin-prick test at screening to one or more allergens in
             the GA2LEN (or the usually used local) panel of seasonal and perennial allergens.
             Subjects must demonstrate an antigen-induced skin prick wheal at least 3 mm in
             diameter greater than diluent control. The positive tests must include the allergen(s)
             prevalent while this study is active.

          -  Subjects must be free of any clinically significant disease, other than IAR, which
             would interfere with the study evaluations.

          -  Subjects, or parents/legal guardians, must give written informed consent. Subjects
             must be able to adhere to dose and visit schedules and meet study requirements.

          -  In females of childbearing potential, the urine pregnancy test (hCG) must be negative
             at the Screening Visit.

          -  Nonsterile or premenopausal female subjects must be using a medically accepted method
             of birth control, that is, oral contraceptive, hormonal implant, medically prescribed
             intrauterine device (IUD), or depot injectable during the entire study. A female
             subject who is not currently sexually active must agree and consent to use one of the
             above-mentioned methods, if she becomes sexually active while participating in the
             study. A female subject who is not of childbearing potential must have a medical
             record of being surgically sterile (for example, hysterectomy and tubal ligation), or
             be at least 1 year postmenopausal.

        Exclusion Criteria:

        The subject will be excluded from entry if ANY of the criteria listed below are met:

          -  Subjects with a history of anaphylaxis and/or severe local reaction(s) to skin testing
             with allergens.

          -  Subjects with intolerable symptoms that would make participating in the study
             unbearable.

          -  Subjects who have had an upper respiratory tract or sinus infection that required
             antibiotic therapy, and have not had at least a 14-day washout prior to the run-in
             period, or who have had a viral upper respiratory infection within 7 days prior to
             screening.

          -  Subjects with asthma who require chronic use of inhaled or systemic corticosteroids.

          -  Subjects with current or a history of frequent, clinically significant sinusitis or
             chronic purulent postnasal drip.

          -  Subjects on immunotherapy (desensitization therapy) unless on a regular maintenance
             schedule prior to Visit 1 and staying on this schedule for the remainder of the study.

          -  Subjects who, in the opinion of the investigator, are dependent on nasal, oral or
             ocular decongestants, nasal topical antihistamines or nasal steroids.

          -  Subjects who have used any drug or device in an investigational protocol in the 30
             days prior to Visit 1.

          -  Female subjects who are pregnant or nursing.

          -  Subjects with a history of hypersensitivity to the study drug or to their excipients
             or known to not tolerate any antihistamines.

          -  Subject is a member of the Investigational Study Staff (currently involved with this
             study) or a member of the staff's family.

          -  Subjects with current evidence of clinically significant hematopoietic,
             cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other
             diseases that preclude the subject's participation in the study.

          -  Subjects whose ability to provide informed consent is compromised.

          -  Subjects with a history of noncompliance with medications or treatment protocols.

          -  Subjects with rhinitis medicamentosa.

          -  Subjects who have, in the opinion of the investigator or designee, clinically
             significant nasal structural abnormalities, including large nasal polyps or marked
             septum deviation, that significantly interferes with nasal air flow.

          -  Subjects who have not observed the medication washout times outlined in the protocol
             prior to Visit 2.