Official Title: “A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Phase II Study to Assess the Efficacy and Safety of RHINOCORT AQUA (Budesonide) Nasal Spray 16mg, 32mg and 64mg Per Day Versus Placebo in Paediatric Subjects Ages 2-5 Years Old With Allergic Rhinitis.”

The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2005

Intervention(s) in this Clinical Trial

• Drug: Budesonide
  • 16mg Nasal Spray
• Drug: Budesonide
  • 32mg Nasal Spray
• Drug: Budesonide
  • 64mg Nasal Spray
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Nasal Spray
• Placebo Comparator: 2

Primary Measures

• To compare Rhinocort with placebo to compare effects on nasal symptoms such as sneezing, runny and stuffy noses as assessed by caregivers.
  • Time Frame: At 2 weeks
    

Secondary Measures

• Safety assessment via adverse events and clinical measurements
  • Time Frame: At 1 & 2 weeks
    
• To assess efficacy of Rhinocort via the physician and caregivers assessments
  • Time Frame: At 2 weeks
    

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 allergic rhinitis and a positive response to a skin prick test at Visit 1 or within the last 12 months for allergens that must be present in the subject's environment for the duration of the study.
• At randomisation having nasal symptom scores as defined by the protocol.

Exclusion Criteria:

• Primary or secondary adrenal insufficiency
• 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.
• A diagnosis of asthma requiring treatment as specifies in the protocol.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 5 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Liza O'Dowd, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641693

Study ID Number: D5360C00703

ClinicalTrials.gov Identifier: NCT00641693

Health Authority: United States: Food and Drug Administration