EUCTR2005-005594-29-SK进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
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
- •-Male or female subjects of 12 years of age or older
- •-Body mass index equal or above -2 SDS (Standard Deviation Score-According to CDC standards)
- •-Have a confirmed diagnosis of cystic fibrosis
- •-Have Screening FEV1 between 55% and 85%.
- •-Have oxygen saturation level measured by pulse oximetry (SpO2) > 90 % on room air
- •-Willing and able to give informed consent
- •-Willing and able to undergo procedures required by this
- •-Stable FEV1 60% or greater of predicted, measured during the run in period within the range of ±5 % between highest and lowest value.
- •-No pulmonary exacerbation during the screening and run in period
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Have a pulmonary disease such as pneumonia, tuberculosis, or lung cancer
- •-Have had an acute upper respiratory tract infection within 2 weeks of screening
- •-Have had an acute lower respiratory tract infection (requiring antibiotics or hospitalization) within 4 weeks of screening
- •-Have had an exacerbation within 4 weeks of screening
- •-Have had any changes from routine maintenance therapy within 4 weeks of screening
- •-Have any scheduled changes to inhaled antibiotics regimen during the course of the study
- •-Are on, or are planned to be on, a tobramycin on-off” treatment regimen
- •-Have completed tobramycin on-off” treatment within less than 6 weeks prior to patient enrollment
- •-Receive parenteral antibiotics via on-off” treatment regimen
- •-Have completed therapy with parenteral antibiotics in on-off” treatment regimen within less than 6 weeks prior to patient enrollment
- •-Are on, or are planned to be on a dornase alfa on-off tretment regimen
- •-Have completed dornase alfa on-off treatment within less than 6 weeks prior to patient enrollment
- •-Have any clinically significant liver, renal, cardiac, neurological, or hematologic disease
- •-Have Burkholderia cepacia or allergic bronchopulmonary aspergillosis.
- •-Have poorly controlled diabetes mellitus
- •-Have smoked more than 3 cigarettes per day within the past 12 months.
- •-Have a history of alcohol (> 40g/day) or drug abuse
- •-Have participated in an investigational drug study within 4 weeks of screening
- •-Have participated in another pharmacological treatment study in which transepithelial chloride transport or ion composition of the epithelial lining fluid might have been influenced within 4 weeks of screening
- •-Show bronchial hyperresponsiveness as known from previous visits e.g. the subject needs additional puffs of salbutamol (or other beta-2-agonists) more than twice daily. This also applies to subjects who have shown bronchoconstriction to previously administered inhalative therapies
- •-Have shown any evidence for unstable lung function, e.g have had more than 10% FEV1 variation (difference between highest and lowest measured value) in the last 3 months before treatment starts
- •-Are women of child bearing potential and refuse to use effective contraception or are pregnant or lactating
- •-Are unwilling to perform appropriate safe contraception for at least 6 months after Study Drug administration
研究者
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