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
- Conditions
- Cystic Fibrosis
- Registration Number
- EUCTR2005-005594-29-SK
- Lead Sponsor
- AOP Orphan Pharmaceuticals AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 360
-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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method