Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Hayfever With or Without Asthma (P03472)
Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Hayfever With or Without Asthma (P03472)
The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius)
 syrup in children with hayfever with or without asthma. Patients took desloratadine syrup
 once a day for 28 days. Once a week, the doctor measured the patient's hayfever symptoms. The
 doctor also rated how much relief the patient got from treatment and recorded any side
 effects.
Inclusion Criteria:

 -  Children must be >= 6 to < 12 years of age of either sex and any race.

 -  Children's parent(s) or legal representative(s) must demonstrate their willingness to
 participate in the study and comply with its procedures by signing an informed consent

 -  Children must be free of any clinically significant disease (other than SAR) that
 would interfere with study evaluations

 -  Children's parent(s) or legal representative(s) must understand and be able to adhere
 to dosing and visit schedules, agree to report concomitant medications and adverse
 events to the Investigator or designee

 -  The diagnosis of seasonal allergic rhinitis with or without intermittent asthma will
 be assessed by:

 -  Clinical history of sneezing, rhinorrhea (nasal discharge/running nose or
 post-nasal drip), nasal stuffiness/congestion and nasal itching and non-nasal
 symptoms (eye symptoms) as itching, burning, tearing and redness, during the
 previous pollen season

 -  Ascertained skin prick positivity (or RAST positivity) to one of the following:
 grasses, parietaria, birch, hazelnut (the skin test has to be performed within
 the last year)

 -  Children must be clinically symptomatic with SAR at Visit 1 (day 1): the total (nasal
 + non nasal) symptoms score must be >= 8 with a nasal congestion score of >= 2, and
 the non-nasal symptoms severity score must be >= 2

 -  Asthma symptoms (wheezing, cough, difficulty breathing, chest tightness) will be
 evaluated at visit 1 (day 1) and graded only for child with concomitant asthma

 Exclusion Criteria:

 -  Children who have not observed the designated washout periods for any of the
 prohibited medications

 -  Children with persistent asthma (mild, moderate or severe) or perennial allergic
 rhinitis (PAR)

 -  Children with rhinitis medicamentosa

 -  Children who have had an upper respiratory tract or sinus infection that required
 antibiotic therapy within 14 days prior to Visit 1 (day 1), or children who have had a
 viral upper respiratory infection within 7 days prior to Visit 1 (day 1)

 -  Children who have nasal structural abnormalities, including nasal polyps and marked
 septal deviation, that significantly interfere with nasal airflow

 -  Children who, in the opinion of the Investigator, are dependent upon nasal, oral or
 ocular decongestants, nasal topical antihistamines, or nasal steroids

 -  Children with a history of hypersensitivity to desloratadine or any of its excipients

 -  Children who have any current clinically significant metabolic, cardiovascular,
 hepatic, renal, immunologic, neurologic, hematologic, gastrointestinal,
 cerebrovascular or respiratory disease, or any other disorder which, in the judgment
 of the Investigator, may interfere with the study evaluations or affect subject safety

 -  A known lack of response to H1-antihistamines