A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years - Intermittent and Daily Treatment for Episodic Asthma (IDEA)

Merck & Co., Inc.0 个研究点目标入组 1,700 人开始时间: 2008年4月1日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Merck & Co., Inc.
入组人数: 1,700

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Patient is a male or female between the ages of 6 months and 5 years (71 months) inclusive.
•2. For patients aged <2 years: patient has had at least 2 but no more than 4 episodes of asthma symptoms (e.g., cough, wheeze, shortness of breath) for approximately 3 days, each involving, at minimum, ß-agonist treatment, AND episodes are separated in time by periods without asthma symptoms (may be obtained as verbal medical history from parent/guardian).
•For patients aged =2 years: patient has a history of episodic asthma symptoms such that in the 12 months prior to Visit 1, patient had at least 3, but not more than 6, episodes of asthma symptoms (e.g., cough, wheeze, shortness of breath) for approximately 3 days, each involving, at minimum, ß-agonist treatment, AND one of these episodes occurred within 6 months of Visit 1, AND episodes are separated in time by periods without asthma symptoms (may be obtained as verbal medical history from parent/guardian).
•3. For patients >1 year: In the 12 months prior to Visit 1, patient had at least 1 corticosteroid treatment (oral, rectal, inhaled, or parenteral) OR was hospitalized for asthma at least 1 time (may be obtained as verbal medical history from parent/guardian).
•For patients <1 year: Patient had at least 1 corticosteroid treatment (oral, rectal, inhaled, or parenteral) OR was hospitalized for asthma at least 1 time (may be obtained as verbal medical history from parent/guardian).
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Patient has a history of persistent asthma symptoms such that daytime symptoms occur >1 time per week and nighttime symptoms occur >2 times per month.
•2. Patient has used any long-term controller medications (inhaled corticosteroids, leukotriene modifiers, cromolyn/nedocromil or theophylline) in the past 2 weeks OR:
•For patients <2 years: for =2 months, cumulatively.
•For patients =2 year: for =4 months, cumulatively, in the 12 months prior to Visit 1.

研究者

发起方

Merck & Co., Inc.

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