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 2 to 5 Years - Intermittent and Daily Treatment for Episodic Asthma (IDEA)

Suomen MSD Oy0 个研究点目标入组 1,771 人开始时间: 2006年8月11日最近更新: 2019年6月30日

研究概览

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•1. Patient is a male or female between the ages of 2 years (24 months) and 5 years (71 months) inclusive.
•2. 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 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. In the 12 months prior to Visit 1, patient had at least 1 corticosteroid treatment (oral, rectal, or inhaled) 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)
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•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 greater than or equal to 4 months, cumulatively, in the 12 months prior to Visit 1.

发起方

Suomen MSD Oy