A randomized, double blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of aerosolized Moli1901 in adolescents (12 years of age or older) and adults with cystic fibrosis - ND

AOP ORPHAN PHARMACEUTICALS0 个研究点目标入组 160 人开始时间: 2007年11月12日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Male or female subject of 12 years age of older BMI > = -2 SDS for 12-19 years old patients and > = 18.5 for adults (20 years or older) Confirmed diagnosis of cystic fibrosis Screening FEV1 between 50 and 85% of predicted Oxigen saturation level > 90% Informed consent
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Bronchial hyperresponsiveness Evidence of instable lung function Pulmonary diseases such as pneumonia, tubercolosis or lung cancer Acute upper respiratory tract infection within the last 2 weeks Acute lower respiratory tract infection within the last 4 weeks Pulmonary exacerbation within the last 4 weeks Any treatment via ''on-off'' regimen in the last 6 weeks or planned Poorly controlled diabetes mellitus Women of childbearing potential refusing effective contraception, or pregnant or lactating

发起方

AOP ORPHAN PHARMACEUTICALS