Allergic Rhinitis
Conditions
Brief summary
This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with allergic rhinitis
Interventions
Sponsors
Meda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Report | 3 months of treatment | reports of treatment emergent adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dymista Nasal Spray azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months
Dymista Nasal Spray | 304 |
| Fluticasone Propionate Nasal Spray fluticasone propionate nasal spray 50mcg per spray per nostril twice a day
Fluticasone propionate nasal spray | 101 |
| Total | 405 |
Baseline characteristics
| Characteristic | Fluticasone Propionate Nasal Spray | Dymista Nasal Spray | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 101 Participants | 304 Participants | 405 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.1 years STANDARD_DEVIATION 1.94 | 8.1 years STANDARD_DEVIATION 2.07 | 8.1 years STANDARD_DEVIATION 1.9 |
| Region of Enrollment United States | 101 participants | 304 participants | 405 participants |
| Sex: Female, Male Female | 49 Participants | 121 Participants | 170 Participants |
| Sex: Female, Male Male | 52 Participants | 183 Participants | 235 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 114 / 304 | 25 / 101 |
| serious Total, serious adverse events | 1 / 304 | 0 / 101 |
Outcome results
Primary
Adverse Events Report
reports of treatment emergent adverse events
Time frame: 3 months of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dymista Nasal Spray | Adverse Events Report | 124 event |
| Fluticasone Nasal Spray | Adverse Events Report | 37 event |