Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis
Condition: Chronic Allergic Rhinitis; Nonallergic Rhinitis
MeSH terms: Rhinitis; Common Cold; Rhinitis, Allergic
Intervention: Astepro Nasal Spray (0.1% azelastine hydrochloride); Astelin Nasal Spray (0.1% azelastine hydrochloride)
Intervention description: 548 mcg (2 sprays per nostril) twice a day; 548 mcg (2 sprays per nostril) twice a day
Intervention MeSH terms: Azelastine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 862.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine
      hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients 12 years of age and older with an established history (> 1
             year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotor
             rhinitis (VMR).

          2. Provide written informed consent/pediatric assent. If the patient is a minor, a parent
             or legal guardian must give written informed consent

          3. Willing and able to comply with the study requirements, including daily use of
             medication for a one year period, even if symptoms are not bothersome.

          4. 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

          5. Patients receiving immunotherapy (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)

        Exclusion Criteria:

          1. The use of any investigational drug within 30 days prior to screening. No other
             investigational products are permitted for use during the conduct of this study

          2. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol
             or sucralose (Splenda® brand sweetener)

          3. Women who are pregnant or nursing

          4. Women of childbearing potential who are not abstinent and not practicing a medically
             acceptable method of contraception. Female patients must practice an acceptable
             contraceptive technique for 30 days before randomization and agree to continue its use
             during treatment and for 30 days after the last dose of study drug. Oral,
             intrauterine, implantable, injectable contraceptives, or a double barrier form of
             contraception are acceptable and the medication including dose, device or method must
             have been stable for at least 30 days before the first dose of study drug.

          5. Nasal disease(s) likely to affect deposition of intranasal medication, such as
             sinusitis,rhinitis medicamentosa or clinically significant nasal polyposis or nasal
             structural abnormalities

          6. Patients with asthma (with the exception of mild, intermittent asthma) or other
             significant pulmonary disease such as Chronic Obstructive Pulmonary Disease

          7. Patients with a known history of alcohol or drug abuse

          8. Existence of any surgical or medical condition, which in the opinion of the
             investigator or sponsor, might significantly alter the evaluation of study

          9. Clinically relevant abnormal history and/or physical findings which, in the opinion of
             the investigator or sponsor, would interfere with the objectives of the study or that
             may preclude compliance with the study procedures

         10. Study site staff, immediate relatives of study site staff, or other individuals who
             would have access to the clinical study protocol