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Sponsored by: |
Teva Global Respiratory Research LLC |
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Information provided by: | Teva Global Respiratory Research LLC |
ClinicalTrials.gov Identifier: | NCT00854360 |
This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group, 2-week, multi-center, dose-range-finding study in male or female patients (12 years and older) with SAR.
Condition | Intervention | Phase |
---|---|---|
Seasonal Allergic Rhinitis Hayfever |
Drug: Beclomethasone dipropionate HFA Nasal Aerosol Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center, Dose Range Finding Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR) |
Estimated Enrollment: | 480 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
80 mcg Total Daily Dose: Experimental |
Drug: Beclomethasone dipropionate HFA Nasal Aerosol
All subjects on active treatment will receive a total of 4 intranasal actuations daily from 2 separate canisters.
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160 mcg Total Daily Dose: Experimental |
Drug: Beclomethasone dipropionate HFA Nasal Aerosol
All subjects on active treatment will receive a total of 4 intranasal actuations daily from 2 separate canisters.
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320 mcg Total Daily Dose: Experimental |
Drug: Beclomethasone dipropionate HFA Nasal Aerosol
All subjects on active treatment will receive a total of 4 intranasal actuations daily from 2 separate canisters.
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Placebo: Placebo Comparator |
Drug: Placebo
HFA Vehicle Aerosol
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
The SAR must have been of sufficient severity to have required treatment (either continuous or intermittent) in the past and in the investigator's judgment is expected to be exposed to the allergen and require treatment throughout the entire study period.
Key Exclusion Criteria:
Study Chair: | Teva Global Respiratory Research Contact | Teva Global Respiratory Research |
Responsible Party: | Teva Global Respiratory Research ( Teva Global Respiratory Research Study Leader ) |
Study ID Numbers: | BDP-AR-201 |
Study First Received: | March 2, 2009 |
Last Updated: | April 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00854360 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Seasonal Allergic Rhinitis Hayfever |
Anti-Inflammatory Agents Otorhinolaryngologic Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Beclomethasone Rhinitis Glucocorticoids |
Hormones Signs and Symptoms Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Otorhinolaryngologic Diseases Immune System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Beclomethasone Rhinitis Hormones |
Glucocorticoids Pharmacologic Actions Nose Diseases Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Therapeutic Uses Hypersensitivity, Immediate Respiratory Hypersensitivity |