Status:
COMPLETED
Children, Perennial Allergic Rhinitis (PAR), l-t Growth
Lead Sponsor:
AstraZeneca
Conditions:
Perennial Allergic Rhinitis
Eligibility:
All Genders
4-10 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the effect of Rhinocort nasal spray with placebo on growth in children with perennial allergic rhinitis over 12 months.
Eligibility Criteria
Inclusion
- In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids.
- A documented history of at least one year of perennial allergic rhinitis.
- A positive response to a skin prick test for perennial allergens that must be present in the subject's environment.
- Height and weight within normal limits.
Exclusion
- Any disease which may affect growth
- Sexual development later than Tanner stage I.
- Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2003
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT00641212
Start Date
January 1 2000
End Date
April 1 2003
Last Update
March 25 2009
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