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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 |
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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 |
Study Completion Date: | May 2009 |
Primary Completion Date: | May 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.
|
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:
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: | July 22, 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 |