Assess the efficacy and safety of Rhinocort Aqua
Study identifier:D5360C00703
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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.
Medical condition
Allergic Rhinitis
Phase
Phase 2
Healthy volunteers
No
Study drug
Budesonide, Placebo
Sex
All
Actual Enrollment
650
Study type
Interventional
Age
2 Years - 5 Years
Date
Study Start Date: 01 Apr 2004
Primary Completion Date: 01 May 2005
Study Completion Date: 01 May 2005
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Nasal Spray | Drug: Budesonide 16mg Nasal Spray Other Name: Rhinocort AQUA Drug: Budesonide 32mg Nasal Spray Other Name: Rhinocort AQUA Drug: Budesonide 64mg Nasal Spray Other Name: Rhinocort AQUA |
| Placebo Comparator: 2 | - |
Contacts
Investigators
Principal Investigator
Liza O'Dowd
AstraZeneca
