Children, Perennial Allergic Rhinitis (PAR), l-t Growth

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Perennial Allergic Rhinitis

Treatments

Drug: Budesonide

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00641212

D5360C00414

SD-005-0414

Details and patient eligibility

About

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.

Enrollment

209 estimated patients

Sex

All

Ages

4 to 10 years old

Volunteers

No Healthy Volunteers

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.