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: 536.0
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:

          -  Male and Female patients 12 years of age and older with a 2 year history of moderate
             to severe seasonal allergic rhinitis.

          -  Must be in generally good health

          -  Must meet minimum symptom requirements, as specified in the protocol

          -  Must be willing and able to provide informed consent and to participate in all study
             procedures

          -  Positive skin test to a prevalent Texas Mountain Cedar allergen

        Exclusion Criteria:

          -  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 subject from the study.

          -  Other nasal disease(s) likely to affect deposition of intranasal medication, such as
             sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal
             structural abnormalities.

          -  Nasal surgery or sinus surgery within the previous year.

          -  Chronic sinusitis - more than 3 episodes per year

          -  Planned travel outside of the study area during the study period

          -  The use of any investigational drug within 30 days prior to Screening. No
             investigational products are permitted for use during the conduct of this study

          -  Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol
             or sucralose (Splenda® brand sweetener)

          -  Women who are pregnant or nursing

          -  Women of childbearing potential who are not abstinent or not practicing a medically
             acceptable method of contraception

          -  Respiratory Tract Infections within 14 days prior to screening

          -  Respiratory Tract Infections requiring antibiotic treatment 14 days prior to screening

          -  Asthma (with the exception of mild, 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

          -  Significant pulmonary disease including COPD

          -  Clinically significant arrhythmia or symptomatic cardiac conditions

          -  A known history of alcohol or drug abuse within the last 2 years

          -  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.

          -  Clinically relevant abnormal physical findings which, in the opinion of the
             investigator, would interfere with the objectives of the study or that may preclude
             compliance with the study procedures