An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease

AOP Orphan Pharmaceuticals AG0 个研究点目标入组 18 人开始时间: 2005年12月23日最近更新: 2012年3月19日

试验速览

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•16 years of age or older (Phase I of Study) resp. 12 years of age or older (Phase II of Study).
•Have a confirmed diagnosis of cystic fibrosis [positive sweat chloride value > 60 mEq/l (by quantitative pilocarpine iontophoresis) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype.
•Have Screening FEV1 greater than 60% of predicted.
•Have oxygen saturation level measured by pulse oximetry (Sp02) > 90 % on room air.
•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

•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.
•Are on a tobramycin on-off” treatment
•Receive parenteral antibiotics via on-off” treatment.
•Have any clinically significant liver, renal, cardiac, neurologic, or hematologic disease.
•Have Burkholderia cepacia or allergic bronchopulmonary aspergillosis.
•Have smoked more than 3 cigarettes per day within the past 12 months.
•Have a history of alcohol (> 40g/d) or drug abuse.
•Have participated in an investigational drug study within 4 weeks of screening.
•Show bronchial hyperresponsiveness.
•Do not have stable lung function, i.e. have more than 10% FEV1 variation 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.

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