Efficacy and safety of Intra-erythrocytes dexamethasone in cystic fibrosis - ND
- Conditions
- Cystic FibrosisMedDRA version: 9.1Level: LLTClassification code 10011762Term: Cystic fibrosis
- Registration Number
- EUCTR2007-001782-15-IT
- Lead Sponsor
- ISTITUTO GIANNINA GASLINI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patient with diagnosis of cystic fibrosis Age 6 >years
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
Sputum positive for Mycobacteri reported membrane defects in erythrocytes and/or hemoglobin anomalies
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Improvement or worsening lt; 2 of FEV1 in front of 18 months precedents the enrolnment;Secondary Objective: improvement of the nutritional status and reduction of the acute episodes of pulmonary infection;Primary end point(s): Improvement or worsening 2 of FEV1 in front of 18 months precedents the enrolnment
- Secondary Outcome Measures
Name Time Method