通用名称

fluticasone propionate

儿科标签批准日期

2021/7/9 0:00:00

特定指示/秒

Maintenance treatment of asthma as prophylactic therapy in pediatric patients 4 to 11 years

标签更改摘要

- Safety and effectiveness in the maintenance treatment of asthma as prophylactic therapy in pediatric patients 4 years and older have been established. - Use for this indication in adolescents ages 12 to 17 years is supported by evidence from two adequate and well-controlled trials in adult and adolescent patients 12 years old and older with persistent symptomatic asthma despite ICS or ICS/LABA therapy (Trials 1 and 2). - Use for this indication in pediatric patients aged 4 to 11 years is supported by evidence from one adequate and well-controlled trial. - In this trial, 419 pediatric patients received Armonair Respiclick 30 mcg or 55mcg one inhalation twice daily. - Safety and effectiveness in patients below the age of 4 years have not been established. - Information on dosing, adverse reactions, and clinical trial. - Postmarketing study.

治疗类别

Antiasthmatic

立法类型

PREA + BPCA

产品说明书链接

书号

2.0 1.0

研究年龄

4 YEARS - 11 YEARS 4 YEARS - 11 YEARS

学习类型

Pharmacokinetic,Tolerability Efficacy,Safety,Tolerability

研究设计

Randomized,Active Comparator,Double-Blind,Single-dose,Crossover Multicenter,Randomized,Placebo,Double-Blind,Parallel Group,Phase 3

登记的患者

24 1256

患者分析

20 841

中心的数量

3 100

国家数量

1 5

西班牙裔拉美裔/拉丁裔总计

8 198

非西班牙裔/非拉丁裔总人数

12 641

总数#种族不明

0 2

亚裔学生总数

0 6

黑人总数

6 135

白人总数

14 683

夏威夷或太平洋岛民总数

0 1

美洲印第安人/阿拉斯加本地人总数

0 3

其他种族总计

0 13

未知种族总数

0 0

国家

United States United States,Georgia,Hungary,Russian Federation,Ukraine