Perennial Allergic Rhinitis
Conditions
Keywords
Allergic rhinitis, Perennial allergic rhinitis, Paediatric, Growth, budesonide, Rhinocort AQUA
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.
Interventions
DRUGBudesonide
DRUGPlacebo
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in height over a 12 month period | 3 monthly |
Secondary
| Measure | Time frame |
|---|---|
| Change in growth velocity over a 12 month period. | 3 monthly |
| Other safety - assessed by adverse event query | 3 monthly |
Outcome results
None listed