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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00641693 |
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.
Condition | Intervention | Phase |
---|---|---|
Allergic Rhinitis |
Drug: Budesonide Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 650 |
Study Start Date: | April 2004 |
Study Completion Date: | May 2005 |
Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Nasal Spray
|
Drug: Budesonide
16mg Nasal Spray
Drug: Budesonide
32mg Nasal Spray
Drug: Budesonide
64mg Nasal Spray
|
2: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 2 Years to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | D5360C00703, SD-005-0703 |
Study First Received: | March 18, 2008 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00641693 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Allergic rhinitis Paediatric Nasal symptoms Congestion |
Rhinorrhea Sneeze budesonide Rhinocort AQUA |
Anti-Inflammatory Agents Otorhinolaryngologic Diseases Hormone Antagonists Budesonide Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Rhinitis |
Glucocorticoids Hormones Respiratory Tract Diseases Respiratory Tract Infections Peripheral Nervous System Agents Bronchodilator Agents |
Anti-Inflammatory Agents Respiratory System Agents Otorhinolaryngologic Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Rhinitis Hormones |
Glucocorticoids Nose Diseases Pharmacologic Actions Respiratory Tract Diseases Respiratory Tract Infections Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |