3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Dymista Nasal Spray; Fluticasone propionate nasal spray
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 405.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with
      allergic rhinitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects ≥ 4 years to <12 years, inclusive at the screening visit

          -  A history of allergic rhinitis (AR)

          -  The parent/caregiver must provide written informed consent and the child must provide
             assent

          -  Willing and able to comply with the study requirements

          -  Require treatment with Dymista Nasal Spray, based on the Investigator's assessment
             (based on medical history, physical examination, etc.) of the subjects' 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

          -  Nasal disease(s) likely to affect deposition of intranasal medication, such as acute
             or chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis or
             clinically significant nasal structural abnormalities

          -  Nasal surgery or sinus surgery within the previous year

          -  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 azelastine hydrochloride and/or fluticasone
             propionate or drugs similar to azelastine hydrochloride and/or fluticasone propionate

          -  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 (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 of the study or that
             may preclude compliance with the study procedures

          -  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 Sections 4.0 and 5.0) and have not had the proper washouts from these
             medications or therapies

          -  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

          -  Positive pregnancy test in female subjects ≥ 9 years of age

          -  Females who are pregnant or nursing practicing a medically acceptable method of
             contraception

          -  Subjects who fail to complete the symptom diary during the lead-in period, defined as
             missing data for >50% of entries