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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2005-004344-30-HU
Date of registration: 23/12/2005
Prospective Registration: Yes
Primary sponsor: AOP Orphan Pharmaceuticals AG
Public title: 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
Scientific title: 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
Date of first enrolment: 10/05/2006
Target sample size: 18
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004344-30
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: Single blind: Double blind: yes Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: yes Other:  
Phase: 
Countries of recruitment
Hungary
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
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

Exclusion criteria:
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.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10,000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride ans water in the lungs thereby reducing the formation of mucus plugs and improving clearance.
Intervention(s)

Product Name: Moli1901 (2622U90, duramycin)
Product Code: EU Orphan Designation Number EU/3/02/120
Pharmaceutical Form: Inhalation vapour, solution
CAS Number: 1391-36-2
Current Sponsor code: Moli1901
Other descriptive name: Duramycin, 2622U90
Concentration unit: g/l gram(s)/litre
Concentration type: equal
Concentration number: 0,5-
Pharmaceutical form of the placebo: Inhalation vapour, solution
Route of administration of the placebo: Inhalation use

Primary Outcome(s)
Main Objective: The study objective is to determine safety and tolerability of a multiple-dose regimens of aerosolized Moli1901 in adolescents (12 years of age or older) and adults with cystic fibrosis and mild to moderate lung disease.
Primary end point(s): •Safety and tolerability will be assessed by evaluating general physical condition, adverse events, changes in pulmonary function test results, pulse oximetry, vital signs, physical examinations, ECGs (electrocardiograms), and clinical laboratory tests. Pulmonary function evaluation will focus on pre-treatment and post-treatment pulmonary function test results as demonstrated by FEV1 (Forced Expiratory Volume in One Second), FVC (Forced Vital Capacity), and FEF25-75 (Forced Expiratory Flow 25–75% of FVC).
•Exercise tolerance will be assessed based on evidence of either improvement or worsening.
•Quality of life will be assessed using a questionnaire to be filled out by the study subjects at Study Start and end of treatment phase and at Study End
Secondary Objective:
Secondary Outcome(s)
Secondary ID(s)
Moli1901-010A
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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