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

Verified by: AstraZeneca, March 2009
First Received: March 18, 2008 | Last Updated: March 24, 2009 | Phase: Phase 4 | Start Date: January 2000
Overall Status: Completed | Estimated Enrollment: 209
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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...

Brief Summary

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.”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
  • Study Primary Completion Date: April 2003

Intervention(s) in this Clinical Trial

  • Drug: Budesonide
  • Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Budesonide
  • Placebo Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in height over a 12 month period
    • Time Frame: 3 monthly

Secondary Measures

  • Change in growth velocity over a 12 month period.
    • Time Frame: 3 monthly
  • Other safety - assessed by adverse event query
    • Time Frame: 3 monthly

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 10 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Bertil Andersson Study Director AstraZeneca  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641212

Study ID Number: SD-005-0414

ClinicalTrials.gov Identifier: NCT00641212

Health Authority: United States: Food and Drug Administration

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