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

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Budesonide

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.