Assess the Efficacy and Safety of Rhinocort Aqua

Allergic Rhinitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641693
• Other study ID #: D5360C00703
• Secondary ID: SD-005-0703
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2008
• Last updated: January 21, 2011
• Start date: April 2004
• Est. completion date: May 2005

Study information

• Verified date: January 2011
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 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 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.

Study Design

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare Rhinocort with placebo to compare effects on nasal symptoms such as sneezing, runny and stuffy noses as assessed by caregivers.		At 2 weeks
Secondary	Safety assessment via adverse events and clinical measurements		At 1 & 2 weeks
Secondary	To assess efficacy of Rhinocort via the physician and caregivers assessments		At 2 weeks