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
- Conditions
- Cystic fibrosisMedDRA version: 6.1Level: PTClassification code 10011763
- Registration Number
- EUCTR2006-006693-24-IT
- Lead Sponsor
- AOP ORPHAN PHARMACEUTICALS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish minimum effective dose, optimal dose and maximum safe dose of MOLI 1901;Secondary Objective: To establish the tolerability of MOLI 1901;Primary end point(s): Change in the percentage of the predicted FEV1 value.
- Secondary Outcome Measures
Name Time Method