Phase
Condition
Rhinitis, Allergic, Perennial
Allergy
Common Cold
Treatment
Placebo
5-mg Desloratadine
Clinical Study ID
Study Summary
Eligibility Criteria
Inclusion
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 ofAR. Subjects must have at least a 2 year history of AR consistent with IAR (definedas symptoms of allergic rhinitis present less than four days per week or for lessthan four consecutive weeks per year); the current episode can count as the secondyear.
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-hourAM-PRIOR (reflective) symptoms severity score of at least 6.
In order for a subject to qualify at the Baseline Visit, the sum of the dailyaverages 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 theBaseline Visit (Day 1) must be >= 30.
Subjects must have a positive skin-prick test at screening to one or more allergensin 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 indiameter greater than diluent control. The positive tests must include theallergen(s) prevalent while this study is active.
Subjects must be free of any clinically significant disease, other than IAR, whichwould interfere with the study evaluations.
Subjects, or parents/legal guardians, must give written informed consent. Subjectsmust be able to adhere to dose and visit schedules and meet study requirements.
In females of childbearing potential, the urine pregnancy test (hCG) must benegative at the Screening Visit.
Nonsterile or premenopausal female subjects must be using a medically acceptedmethod of birth control, that is, oral contraceptive, hormonal implant, medicallyprescribed intrauterine device (IUD), or depot injectable during the entire study. Afemale subject who is not currently sexually active must agree and consent to useone of the above-mentioned methods, if she becomes sexually active whileparticipating in the study. A female subject who is not of childbearing potentialmust have a medical record of being surgically sterile (for example, hysterectomyand tubal ligation), or be at least 1 year postmenopausal.
Exclusion
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 skintesting with allergens.
Subjects with intolerable symptoms that would make participating in the studyunbearable.
Subjects who have had an upper respiratory tract or sinus infection that requiredantibiotic therapy, and have not had at least a 14-day washout prior to the run-inperiod, or who have had a viral upper respiratory infection within 7 days prior toscreening.
Subjects with asthma who require chronic use of inhaled or systemic corticosteroids.
Subjects with current or a history of frequent, clinically significant sinusitis orchronic purulent postnasal drip.
Subjects on immunotherapy (desensitization therapy) unless on a regular maintenanceschedule prior to Visit 1 and staying on this schedule for the remainder of thestudy.
Subjects who, in the opinion of the investigator, are dependent on nasal, oral orocular decongestants, nasal topical antihistamines or nasal steroids.
Subjects who have used any drug or device in an investigational protocol in the 30days prior to Visit 1.
Female subjects who are pregnant or nursing.
Subjects with a history of hypersensitivity to the study drug or to their excipientsor known to not tolerate any antihistamines.
Subject is a member of the Investigational Study Staff (currently involved with thisstudy) or a member of the staff's family.
Subjects with current evidence of clinically significant hematopoietic,cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, orother 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, clinicallysignificant nasal structural abnormalities, including large nasal polyps or markedseptum deviation, that significantly interferes with nasal air flow.
Subjects who have not observed the medication washout times outlined in the protocolprior to Visit 2.