Randomized Trial of the Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 14
- 主要终点
- Safety
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •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
- •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
研究组 & 干预措施
Astepro 0.15% Nasal Spray
Nasal Spray at a dosage of 1 spray per nostril twice daily
干预措施: 205.5 mcg of azelastine hydrochloride (Drug)
Astepro 0.1% Nasal Spray
Nasal Spray at a dosage of 1 spray per nostril twice daily
干预措施: 137 mcg of azelastine hydrochloride (Drug)
结局指标
主要结局
Safety
时间窗: one month of treatment
The objective of this clinical trial is to evaluate the safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray at a dosage of 1 spray per nostril twice daily in subjects ≥6months to \<6 years of age with allergic rhinitis. Safety will be assessed on the basis of reported adverse experiences, nasal examinations, laboratory evaluations, and vital signs assessments. Data for each age strata will be summarized separately as well as combined.
次要结局
未报告次要终点