A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: 0.15% azelastine hydrochloride; 0.1% azelastine hydrochloride; Placebo
Intervention description: 0.15% azelastine hydrochloride 1644 mcg; 0.1% azelastine hydrochloride 1096 mcg; Placebo
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: 581.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients 12 years of age and older

          -  Must be in generally good health

          -  Must meet minimum symptom requirements, as specified in protocol

          -  Must be willing and able to provide informed consent and participate in all study
             procedures

          -  2-year history of PAR

          -  Positive skin test to cockroach, dust mite, mold or cat/dog dander

        Exclusion Criteria:

          -  On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal
             septal perforation at the screening or randomization visit

          -  Nasal diseases likely to affect deposition of intranasal medication, such as
             sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural
             abnormalities

          -  Nasal surgery or sinus surgery within the previous year

          -  The use of any investigational drug within 30 days

          -  Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol
             or sucralose

          -  Women who are pregnant or nursing

          -  Women of child-bearing potential who are not abstinent and not practicing a medically
             acceptable method of contraception

          -  Respiratory tract infection within 2 weeks of screening

          -  Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of
             screening

          -  Patients with asthma with the exception of mild, intermittent

          -  Significant pulmonary disease including COPD

          -  Patients with arrhythmia

          -  Patients with a known history of alcohol or drug abuse

          -  Existence of any surgical or medical condition, which in the opinion of the
             investigator or sponsor may significantly alter the absorption, distribution,
             metabolism or excretion of study drug.

          -  Clinically relevant abnormal physical findings within one week of randomization

          -  Overnight abscences from home for more than 3 nights

          -  Employees of the research center or private practice and family members are excluded

          -  Patients who received prohibited medications within specified timepoints in protocol.