A Randomized, Double Blind, Placebo Controlled, Parallel Group, Study Investigating the Safety and Efficacy Over 12 Weeks Treatment Period of MAP0010 in Asthmatic Infants and Children 12 Months to 8 Years of Age

MAP Pharmaceuticals, Inc.0 个研究点目标入组 360 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•*Male or female asthmatic children with mild to moderate persistant asthma.
•*12 months to 8 years of age.
•*For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
•*For infants age 12 to <48 months old: 2 or more wheezing episodes in past 12 months which lasted >1 day and affected sleep.
•*AND with at least one major or two minor risk factors.

•*Any other significant childhood illness/abnormality or chronic lung disease.
•*Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
•*Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
•*Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
•*Any use of oral corticosteroids within 30 days of screening or prolonged use (>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.

发起方

MAP Pharmaceuticals, Inc.