Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With AR
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: 205.5 mcg of azelastine hydrochloride; 137 mcg of azelastine hydrochloride
Intervention description: nasal spray; nasal spray
Intervention MeSH terms: Azelastine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 191.0
Sex: All
Minimum age: 6 Months
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the safety of 2 different doses of the
      investigational use of an allergy medication (Astepro Nasal Spray) in the treatment of
      allergic rhinitis (AR). This is an open-label study; that is, parent and child will know
      which group each is in.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects >6 months to <6 years, inclusive at the screening visit

          -  A history of AR

          -  The parent must provide written informed consent and the child must provide assent, if
             possible

          -  Willing and able to comply with the study requirements

          -  May benefit from treatment with Astepro Nasal Spray, based on the Investigator's
             assessment (based on medical history, physical examination, etc.) of the subject's
             clinical condition, at both the Screening and Randomization Visits

          -  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

          -  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)

        Exclusion Criteria:

          -  On nasal examination, subjects with superficial nasal mucosal erosion, moderate nasal
             mucosal erosion, nasal mucosal ulceration, nasal septum perforation

          -  Other nasal disease(s) likely to affect deposition of intranasal medication, such as
             acute sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal
             structural abnormalities

          -  Nasal surgery or sinus surgery within the previous year

          -  Chronic sinusitis

          -  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

          -  Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol
             or sucralose (Splenda® brand sweetener)

          -  Respiratory tract infections within two weeks prior to Visit 1.

          -  Subjects with significant pulmonary disease including asthma. Subjects with
             intermittent asthma who only require short-acting inhaled bronchodilators are eligible
             for enrollment. Asthma (with the exception of intermittent asthma). Subjects with
             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

          -  Chronic obstructive sleep apnea syndrome (clinical diagnosis)

          -  Existence of any surgical or medical condition, 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 subject's ability to complete this trial

          -  Clinically relevant abnormal physical findings or laboratory results which, in the
             opinion of the investigator, would interfere with the objectives -- Family members of
             research center or private practice personnel who are directly involved in this study
             are excluded

          -  Members of the same family cannot enroll in the study at the same time.

          -  Subjects who have used medications or therapies that could interfere with safety
             evaluations (see Section 4.0)

          -  Any behavioral condition which could affect subject's ability to accurately report
             symptoms to the caregiver such as developmental delay, attention deficit disorder, and
             autism