Children, Perennial Allergic Rhinitis (PAR), l-t Growth
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Perennial Allergic Rhinitis
Intervention: Budesonide (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Bertil Andersson, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Long-Term Treatment With Rhinocort Aqua (Budesonide) Nasal Spray in Children With Perennial Allergic Rhinitis.
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in height over a 12 month period
Secondary outcome: Change in growth velocity over a 12 month period.Other safety - assessed by adverse event query
Eligibility
Minimum age: 4 Years.
Maximum age: 10 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Additional Information
Starting date: January 2000
Ending date: June 2003
Last updated: March 24, 2008
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