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Sponsored by: |
Meda Pharmaceuticals |
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Information provided by: | Meda Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00883168 |
The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component 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 |
Estimated Enrollment: | 1800 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (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 mg
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3: Active Comparator
fluticasone propionate
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Drug: fluticasone propionate
fluticasone propionate 200 mcg
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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 548 mcg/fluticasone propionate 200 mcg
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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:
Subjects receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections do not preclude participation).
Dose reduction when a new vial is used does not preclude participation.
Exclusion Criteria:
Contact: Carrie L D'Andrea, MS | 732-564-2538 |
Study Director: | Lewis M Fredane, MD | Meda Pharmaceuticals |
Responsible Party: | Meda Pharmaceuticals ( Harry Sacks, MD Vice president, medical Affairs ) |
Study ID Numbers: | MP4006 |
Study First Received: | April 16, 2009 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00883168 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Neurotransmitter Agents Otorhinolaryngologic Diseases Anti-Asthmatic Agents Rhinitis Anti-Allergic Agents Azelastine Lipoxygenase Inhibitors Histamine Hypersensitivity Histamine Antagonists |
Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Fluticasone Histamine H1 Antagonists Histamine phosphate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Rhinitis Azelastine Hypersensitivity Respiratory Tract Infections Respiratory Tract Diseases Therapeutic Uses Fluticasone Dermatologic Agents Otorhinolaryngologic Diseases Immune System Diseases |
Anti-Asthmatic Agents Histamine Agents Enzyme Inhibitors Anti-Allergic Agents Nose Diseases Pharmacologic Actions Lipoxygenase Inhibitors Histamine Antagonists Autonomic Agents Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine H1 Antagonists Peripheral Nervous System Agents Histamine H1 Antagonists, Non-Sedating Bronchodilator Agents |