A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies
NCT ID: NCT00720278
Last Updated: 2010-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
526 participants
INTERVENTIONAL
2007-08-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo Nasal Spray
Placebo nasal spray
Placebo
0 mcg Placebo daily
Astepro 0.1%
0.1% azelastine hydrochloride nasal spray
0.1% azelastine hydrochloride 1096 mcg daily
0.1% azelastine hydrochloride 1096 mcg daily
Astepro 0.15%
0.15% azelastine hydrochloride nasal spray
0.15% azelastine hydrochloride 1644 mcg daily
0.15% azelastine hydrochloride 1644 mcg daily
Interventions
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0.15% azelastine hydrochloride 1644 mcg daily
0.15% azelastine hydrochloride 1644 mcg daily
0.1% azelastine hydrochloride 1096 mcg daily
0.1% azelastine hydrochloride 1096 mcg daily
Placebo
0 mcg Placebo daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
3. Screening Visit: Have a 12-hour reflective TNSS of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Day -7
4. 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)
5. Randomization Visit: An instantaneous TNSS of ≥ 8 before beginning the onset of action assessment on Day 1
6. Must have taken at least 10 doses of study medication during the lead-in period
7. Willing and able to comply with the study requirements
8. At least a 2-year history of SAR
9. The presence of IgE-mediated hypersensitivity to ragweed antigen or other local fall allergens, confirmed by a positive response to either skin prick within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the negative control for the skin prick test.
10. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer. When in doubt, the investigator should confer with the sponsor's medical monitor or designee to determine eligibility for the study.
11. Patients 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 does not preclude participation). Patients currently receiving sublingual immunotherapy are excluded. A 6-month washout period is required following the last dose of sublingual immunotherapy.
Exclusion Criteria
2. Other nasal disease(s) likely such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
3. Nasal surgery or sinus surgery within the previous year.
4. Chronic sinusitis - more than 3 episodes per year
5. Planned travel outside of the study area during the study period
6. The use of any investigational drug within 30 days prior to Day -7. No investigational products are permitted for use during the conduct of this study
7. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
8. Women who are pregnant or nursing
9. Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception
10. Respiratory Tract Infections within 14 days prior to Day -7
11. Respiratory Tract Infections requiring oral antibiotic within 14 days of Day -7
12. Asthma (with the exception of mild, intermittent asthma). Patients with mild, intermittent asthma who only require short-acting inhaled bronchodilators are eligible for enrollment.
13. Significant pulmonary disease including COPD
14. Clinically significant arrhythmia or with symptomatic cardiac conditions
15. A known history of alcohol or drug abuse
16. Existence of any surgical or medical condition or physical or laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug or that might significantly affect the patient's ability to complete this trial.
17. Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
18. Participation in MedPointe Protocols MP433, MP434, MP435, or MP436.
19. Employees of the research center or private practice and their family members are excluded
20. Patients who received prohibited medications within specified timepoints in the protocol.
12 Years
ALL
No
Sponsors
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Meda Pharmaceuticals
INDUSTRY
Responsible Party
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Med Pharmaceuticals
Locations
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Center of Research Excellence, LLC
Oxford, Alabama, United States
Clinical Research Center
Encinitas, California, United States
Allergy Research Foundation
Los Angeles, California, United States
Southern California Research
Mission Viejo, California, United States
Allergy Associates Medical Group Inc
San Diego, California, United States
Storms Clinical Research Institute
Colorado Springs, Colorado, United States
Colorado Allergy and Asthma Centers
Denver, Colorado, United States
ENTA Allergy, Head and Neck Associates
Decatur, Illinois, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, United States
Family Allergy and Asthma Reserach
Louisville, Kentucky, United States
Northeast Medical Research Associates
North Dartmouth, Massachusetts, United States
Clinical Research Institute
Plymouth, Minnesota, United States
Allergy, Asthma and Immunology Associates
Lincoln, Nebraska, United States
Atlantic Research Center
Ocean City, New Jersey, United States
Princeton Center for Clinical Research
Skillman, New Jersey, United States
Research Asthma, Sinus and Allergy Centers
Warren Township, New Jersey, United States
AAIR Research Center
Rochester, New York, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, United States
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States
Allergy and Consultants of NJ/PA
Collegeville, Pennsylvania, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
National Allergy, Asthma and Urticaria of Charleston
Charleston, South Carolina, United States
East Tennesse Center for Clinical Research
Knoxville, Tennessee, United States
Allergy and Asthma Associates
Austin, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Biogenics Research Institute
San Antonio, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Allergy and Asthma Care
Waco, Texas, United States
Countries
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Other Identifiers
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MP438
Identifier Type: -
Identifier Source: org_study_id
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