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Sponsored by: |
CyDex Pharmaceuticals, Inc. |
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Information provided by: | CyDex Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00938613 |
The primary objective of this study was to compare the relative efficacy of Budesonide administered via Captisol-Enabled Budesonide nasal solution and Rhinocort Aqua in patients with seasonal allergic rhinitis (SAR) exposed to controlled ragweed pollen using an EEC model.
Condition | Intervention | Phase |
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Seasonal Allergic Rhinitis |
Drug: Budesonide Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Compare the Relative Efficacy of Budesonide Administered Via CE Budesonide Nasal Solution & Rhinocort Aqua in the Treatment of the Symptoms of AR in an EEC Model |
Enrollment: | 65 |
Study Start Date: | February 2007 |
Study Completion Date: | April 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Captisol-Enabled Budesonide: Experimental
32 ug/spray
|
Drug: Budesonide
nasal spray, one spray per nostril at time 0
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Rhinocort Aqua: Active Comparator
32 ug/spray
|
Drug: Budesonide
nasal spray, one spray per nostril at time 0
|
Placebo: Placebo Comparator
posphate buffered saline
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Drug: Placebo
nasal spray, one spray per nostril at time 0
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A Randomized, Double-Blind, Placebo-Controlled, Single-Center, Three-Way Cross-Over Study to Compare the Relative Efficacy of Budesonide administered via Captisol-Enabled® Budesonide Nasal Solution and Rhinocort Aqua® (32 µg/spray) in the Treatment of the Symptoms of Allergic Rhinitis in an Environmental Exposure Chamber (EEC).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Females of childbearing potential must have a confirmed absence of pregnancy and must be using an acceptable birth control method
Exclusion Criteria:
Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the patient's ability to participate in the clinical trial:
Canada, Ontario | |
Allied Research International - Cetero Research | |
Mississauga, Ontario, Canada, L4W 1N2 |
Principal Investigator: | Deepen Patel, MD | Allied Research International - Cetero Research |
Responsible Party: | Allied Research International - Cetero Research ( Deepen Patel, MD, CCFP/Senior Medical Director ) |
Study ID Numbers: | CDX947CT001, P2DS06001 |
Study First Received: | July 13, 2009 |
Last Updated: | July 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00938613 History of Changes |
Health Authority: | Canada: Health Canada |
SAR |
Anti-Inflammatory Agents Otorhinolaryngologic Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Rhinitis Hormones Glucocorticoids |
Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Otorhinolaryngologic Diseases Immune System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Rhinitis Hormones Glucocorticoids Pharmacologic Actions |
Nose Diseases Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Autonomic Agents Therapeutic Uses Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |