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Sponsored by: |
Meda Pharmaceuticals |
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Information provided by: | Meda Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00740792 |
The purpose of this study is to determine if two allergy medications (formulated azelastine and fluticasone product) are more effective than placebo or either medication alone (azelastine or fluticasone)
Condition | Intervention | Phase |
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Seasonal Allergic Rhinitis |
Drug: Placebo Drug: azelastine hydrochloride Drug: fluticasone propionate Drug: azelastine hydrochloride/fluticasone propionate formulated product |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis. |
Enrollment: | 779 |
Study Start Date: | August 2008 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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2: Active Comparator
azelastine hydrochloride
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Drug: azelastine hydrochloride
azelastine hydrochloride 548 mcg
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3: Active Comparator
fluticasone propionate
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Drug: fluticasone propionate
fluticasone propionate 200mcg
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4: Experimental
azelastine hydrochloride/fluticasone propionate formulated product
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Drug: azelastine hydrochloride/fluticasone propionate formulated product
azelastine hydrochloride 548mcg/fluticasone propionate 200mcg
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must have moderate-to-severe rhinitis, defined as rhinitis with one or more of the following being present:
Exclusion Criteria:
Study Director: | Lewis M Fredane, MD | Meda Pharmaceuticals |
Responsible Party: | Meda Pharmaceuticals ( Harry Sacks, MD Vice President, Medical and Scientific Affairs ) |
Study ID Numbers: | MP4004 |
Study First Received: | August 22, 2008 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00740792 |
Health Authority: | United States: Food and Drug Administration |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate |
Histamine phosphate Fluticasone Rhinitis Azelastine Histamine Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Histamine Agents Enzyme Inhibitors Anti-Allergic Agents Nose Diseases |
Pharmacologic Actions Lipoxygenase Inhibitors Histamine Antagonists Autonomic Agents Therapeutic Uses Histamine H1 Antagonists Peripheral Nervous System Agents Histamine H1 Antagonists, Non-Sedating Dermatologic Agents Bronchodilator Agents |