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| Sponsor: | Meda Pharmaceuticals |
|---|---|
| Information provided by: | Meda Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00824473 |
Purpose
The purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: Placebo Drug: 0.15% azelastine hydrochloride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Subjects With Seasonal Allergic Rhinitis |
rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate.
instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
reflective and instantaneous symptom scores (itchy eyes, watery eyes and red eyes) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible TOSS score is 9 per day.
Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.
Scores for a series of subsclaes are not combined for a total overall score, rather domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.
| Enrollment: | 506 |
| Study Start Date: | December 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo
|
Drug: Placebo
Placebo
|
|
Active Comparator: 2
0.15% azelastine hydrochloride
|
Drug: 0.15% azelastine hydrochloride
0.15% azelastine hydrochloride 822 mcg
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Allergy and Asthma Associates | |
| Austin, Texas, United States, 78731 | |
| Allergy and Asthma Center of Austin | |
| Austin, Texas, United States, 78759 | |
| Central Texas Health Research | |
| New Braunfels, Texas, United States, 78130 | |
| Sylvana Research Associates | |
| San Antonio, Texas, United States, 78229 | |
| Allergy, Asthma Research Center | |
| San Antonio, Texas, United States, 78258 | |
| Southwest Allergy and Asthma Center, P.A. | |
| San Antonio, Texas, United States, 78229 | |
| Allergy and Asthma Center | |
| Waco, Texas, United States, 76712 | |
| Study Director: | Lewis M Fredane, MD | Meda Pharmaceuticals |
More Information
| Responsible Party: | Harry Sacks, MD Vice President, Medical and Scientific Affairs, Meda Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00824473 History of Changes |
| Other Study ID Numbers: | MP443 |
| Study First Received: | January 14, 2009 |
| Results First Received: | September 30, 2009 |
| Last Updated: | February 19, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections Azelastine Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists |
Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Lipoxygenase Inhibitors Enzyme Inhibitors Anti-Allergic Agents Therapeutic Uses Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |