A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Placebo; 0.15% azelastine hydrochloride
Intervention description: Placebo; 0.15% azelastine hydrochloride 822 mcg
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: 506.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if one allergy medication (0.15% azelastine
      hydrochloride) is more effective than Placebo alone
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects 12 years of age and older

          2. Provide written informed consent/pediatric assent. If the subject 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 visit 1

          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 visit 2, and can
             include the morning of visit 2) 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 visit 2, and can
             include the morning of visit 2)

          5. Willing and able to comply with the study requirements

          6. At least a 2-year history of SAR during Texas Mountain Cedar season

          7. The presence of IgE-mediated hypersensitivity to Texas Mountain Cedar, confirmed by a
             positive response to 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.

          8. 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.

          9. Subjects 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 do not preclude
             participation).Dose reduction when a new bottle is used does not preclude
             participation.

         10. Subjects 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 superficial and moderate nasal
             mucosal erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1b-4) at
             either screening visit or randomization visit will disqualify the subjects from the
             study.

          2. Other nasal disease(s) likely to affect deposition of intranasal medication, such as
             sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically
             significant 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 visit 1. 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 visit 1

         11. Respiratory Tract Infections requiring antibiotic treatment 14 days prior to visit 1

         12. Asthma (with the exception of intermittent asthma). Subjects with mild, intermittent
             asthma who only require short-acting inhaled bronchodilators (not more often than
             twice per week) and who do not have nocturnal awakening as a result of asthma are
             eligible for enrollment

         13. Significant pulmonary disease including COPD

         14. Clinically significant arrhythmia or symptomatic cardiac conditions

         15. A known history of alcohol or drug abuse within the last 2 years

         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; that might significantly affect the subject's ability to complete this trial; or
             their safety in 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 MP439 or MP440.

         19. Employees of the research center / private practice and their family are excluded