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A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies

Information source: Meda Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: 0.15% azelastine hydrochloride 1644 mcg daily (Drug); 0.1% azelastine hydrochloride 1096 mcg daily (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Meda Pharmaceuticals


The purpose of this study was to determine if two allergy medications are more effective than placebo.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo

Secondary outcome:

Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo

Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo

Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older

Change From Baseline on Direct Visual Nasal Exams


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.

Locations and Contacts

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

Additional Information

Starting date: August 2007
Last updated: February 19, 2010

Page last updated: August 23, 2015

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