Observational Study Evaluating the Safety and Efficacy of Desloratadine Syrup for Perennial Allergic Rhinitis in Indonesian Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 591
- 主要终点
- General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments
研究概览
简要总结
Evaluate the safety and general clinical response of desloratadine syrup in the relief of symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.
详细描述
Children, ages 2-11, with a history of perennial allergic rhinitis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children patients of both sexes aged between 2-11 years, of either gender and any race
- •Unequivocal history of perennial allergic rhinitis, including nasal congestion, sneezing, rhinorrhea, pruritus, and lacrimation
- •Minimum score for inclusion: 10
- •Capable of complying with the dosing regimen
- •Free of any clinically significant disease (other than allergic rhinitis)
- •Antihistamine must be justified by investigating doctor
排除标准
- •Patients with asthma who require chronic use of inhaled or systemic corticosteroids
- •History of frequent, clinically significant sinusitis or chronic purulent postnasal drip
- •Patients with rhinitis medicamentosa
- •History of hypersensitivity to desloratadine or any of its excipients
- •Doctor deems unsuitable
研究组 & 干预措施
1
Children with a history of perennial allergic rhinitis
干预措施: Desloratadine (assigned by investigator as part of normal practice) (Drug)
结局指标
主要结局
General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments
时间窗: Minimum of 7 days after initiation of desloratadine
Physicians judged the subjects as good, excellent, fair, or poor.
Adverse Events
时间窗: Minimum of 7 days after initiation of desloratadine
An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines.
次要结局
未报告次要终点