A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: 0.15% azelastine hydrochloride 1644 mcg daily; 0.1% azelastine hydrochloride 1096 mcg daily; Placebo
Intervention description: 0.15% azelastine hydrochloride 1644 mcg daily; 0.1% azelastine hydrochloride 1096 mcg daily; 0 mcg Placebo daily
Intervention MeSH terms: Azelastine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 526.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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.