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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Approximately 200 subjects, between the ages of ≥ 6 months to < 6 years of age who have a
      history of AR will participate in this study.

      The study will be conducted at about 20 research centers in the United States. Each research
      center will enroll approximately 2 to 10 subjects.

      The study will involve at least 4 office visits over at least a 4-week period. You will need
      to keep the appointments as scheduled by the study personnel.

      Some medications or therapies could interfere with the safety evaluations conducted in this
      study. If your child is currently taking any of these medications or therapies, they will
      need to discontinue them in order to be eligible for this study. Your study doctor will
      discuss this with you along with information on how this could affect your child's health. If
      you and the study doctor decide this is appropriate, there is a specific time period that
      these will need to be discontinued before your child can proceed in study evaluation.

      If your child is eligible for study participation, he/she will be randomly assigned (by
      chance, like the flip of a coin) to one of the following two study drug groups:

        -  Astepro (azelastine hydrochloride) 0.15% Nasal Spray, 822 mcg (total daily dose); OR

        -  Astepro (azelastine hydrochloride) 0.1% Nasal Spray, 548 mcg (total daily dose)

      The following are being performed for the purposes of this study and are not considered
      standard care:

        -  Your child will be placed in one of the two study drug groups by chance.

        -  You will complete questionnaires about your child's allergy symptoms.

        -  You will complete diary cards each morning recording your child's allergy symptoms over
           the previous 24 hours.

        -  Your child will have his/her vital signs measured (blood pressure, pulse, temperature
           and breathing rate).

        -  You and your child will be asked questions regarding your child's use of any medication
           or supplements and how your child has felt since his/her last visit.

        -  Blood and urine samples will be collected to assess the safety of taking the study drug.
    

Intervention name(s): 205.5 mcg of azelastine hydrochloride; 137 mcg of azelastine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): nasal spray; nasal spray
Other intervention name(s): astepro .15%; astepro .1%
Intervention MeSH terms: Azelastine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment