Intervention: Azelastine Hydrochloride
Trial phase: Phase 4
SMILES: CN1CCCC(n2nc(Cc3ccc(Cl)cc3)c3ccccc3c2=O)CC1.Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 96
Group description: Nasal Spray at a dosage of 1 spray per nostril twice daily

137 mcg of azelastine hydrochloride: nasal spray
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