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Sponsored by: |
Meda Pharmaceuticals |
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Information provided by: | Meda Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00720278 |
The purpose of this study was to determine if two allergy medications are more effective than placebo.
Condition | Intervention | Phase |
---|---|---|
Seasonal Allergic Rhinitis |
Drug: 0.15% azelastine hydrochloride 1644 mcg daily Drug: 0.1% azelastine hydrochloride 1096 mcg daily Drug: Placebo |
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, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 Compared to Placebo in Patients With Seasonal Allergic Rhinitis |
Enrollment: | 526 |
Study Start Date: | August 2007 |
Study Completion Date: | November 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Placebo
|
Drug: Placebo |
2: Experimental
0.1% azelastine hydrochloride
|
Drug: 0.1% azelastine hydrochloride 1096 mcg daily |
3: Experimental
0.15% azelastine hydrochloride
|
Drug: 0.15% azelastine hydrochloride 1644 mcg daily |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM or PM 12-hour reflective nasal congestion score of 2 or 3 must have been recorded on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day
1)
Randomization Visit: An instantaneous TNSS of ≥ 8 before beginning the onset of action assessment on Day
1
Exclusion Criteria:
Responsible Party: | Med Pharmaceuticals ( Harry Sacks, MD Vice President, Medical and Scientific Affairs ) |
Study ID Numbers: | MP438 |
Study First Received: | July 21, 2008 |
Last Updated: | May 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00720278 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neurotransmitter Agents Otorhinolaryngologic Diseases Anti-Asthmatic Agents Rhinitis Anti-Allergic Agents Azelastine Lipoxygenase Inhibitors Histamine Hypersensitivity Respiratory Tract Diseases |
Respiratory Tract Infections Histamine Antagonists Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Histamine H1 Antagonists Histamine phosphate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
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 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 Respiratory Hypersensitivity |