The purpose of this study was to determine if two allergy medications are more effective
than placebo.
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
1. Male and female patients 12 years of age and older
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:
1. On Focused Nasal Examination, the presence of any nasal mucosal erosion, nasal
ulceration, or nasal septal perforation at either the screening visit or
randomization visit will disqualify the patient from the study.
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.
Center of Research Excellence, LLC, Oxford, Alabama 36203, United States
Clinical Research Center, Encinitas, California 92024, United States
Allergy Research Foundation, Los Angeles, California 90025, United States
Southern California Research, Mission Viejo, California 92691, United States
Allergy Associates Medical Group Inc, San Diego, California 92120, United States
Storms Clinical Research Institute, Colorado Springs, Colorado 80907, United States
Colorado Allergy and Asthma Centers, Denver, Colorado 80230, United States
ENTA Allergy, Head and Neck Associates, Decatur, Illinois 62526, United States
Sneeze, Wheeze and Itch Associates, Normal, Illinois 61761, United States
Family Allergy and Asthma Reserach, Louisville, Kentucky 40215, United States
Northeast Medical Research Associates, North Dartmouth, Massachusetts 02747, United States
Clinical Research Institute, Plymouth, Minnesota 55441, United States
Allergy, Asthma and Immunology Associates, Lincoln, Nebraska 68505, United States
Atlantic Research Center, Ocean, New Jersey 07712, United States
Princeton Center for Clinical Research, Skillman, New Jersey 08558, United States
Research Asthma, Sinus and Allergy Centers, Warren, New Jersey 07059, United States
AAIR Research Center, Rochester, New York 14618, United States
North Carolina Clinical Research, Raleigh, North Carolina 27607, United States
Bernstein Clinical Research Center, Cincinnati, Ohio 45231, United States
Allergy, Asthma and Clinical Research Center, Oklahoma City, Oklahoma 73120, United States
Allergy and Consultants of NJ/PA, Collegeville, Pennsylvania 19426, United States
Allergy and Clinical Immunology Associates, Pittsburgh, Pennsylvania 15241, United States
National Allergy, Asthma and Urticaria of Charleston, Charleston, South Carolina 29407, United States
East Tennesse Center for Clinical Research, Knoxville, Tennessee 37909, United States
Allergy and Asthma Associates, Austin, Texas 78731, United States
Central Texas Health Research, New Braunfels, Texas 78130, United States
Biogenics Research Institute, San Antonio, Texas 78229, United States
Sylvana Research Associates, San Antonio, Texas 78229, United States
Allergy and Asthma Care, Waco, Texas 76708, United States