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

Perennial Allergic Rhinitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641212
• Other study ID #: SD-005-0414
• Secondary ID: D5360C00414
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2008
• Last updated: March 24, 2009
• Start date: January 2000
• Est. completion date: April 2003

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 10 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Budesonide

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in height over a 12 month period		3 monthly
Secondary	Change in growth velocity over a 12 month period.		3 monthly
Secondary	Other safety - assessed by adverse event query		3 monthly