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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00641680 |
The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
Condition | Intervention | Phase |
---|---|---|
Seasonal Allergic Rhinitis |
Drug: Budesonide Drug: Fluticasone propionate Drug: Placebo |
Phase III |
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 IIIb Study to Assess the Efficacy, Safety & Product Attributes of Rhinocort Aqua(Budesonide) Versus Placebo and FluticasonePropionate as an Active Comparator in Patients 12yrs Age &Older With SeasonalAllergicRhinitis |
Estimated Enrollment: | 750 |
Study Start Date: | April 2003 |
Study Completion Date: | July 2003 |
Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Budesonide
|
Drug: Budesonide |
2: Active Comparator
Fluticasone propionate
|
Drug: Fluticasone propionate |
3: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
is a candidate for treatment with nasal steroids based on a history of either
Exclusion Criteria:
Study ID Numbers: | D5360C00005 |
Study First Received: | March 18, 2008 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00641680 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Seasonal allergic rhinitis Nasal symptoms Congestion Rhinorrhea Sneeze |
budesonide Rhinocort AQUA Fluticasone propionate Flonase |
Anti-Inflammatory Agents Otorhinolaryngologic Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Rhinitis Anti-Allergic Agents Hormones Glucocorticoids |
Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Rhinitis Hormones Hypersensitivity Respiratory Tract Infections Respiratory Tract Diseases Therapeutic Uses Fluticasone Dermatologic Agents Otorhinolaryngologic Diseases |
Immune System Diseases Budesonide Anti-Asthmatic Agents Anti-Allergic Agents Glucocorticoids Nose Diseases Pharmacologic Actions Autonomic Agents Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |