Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosis
- Conditions
- Adult patient with cystic fibrosisMedDRA version: 14.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2011-001821-26-IT
- Lead Sponsor
- FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Out patient, both sexes, age 18-45. - diagnosys of cystic fibrosis - FEV1 >50% predicted - availability of sputum sample for microbiology - chest X ray negative for pneumonia and active tubercolosis - signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Hypersensibility or allergy to the study drug -use of systemic steroids (less than 2 weeks from the screening) - Pregnancy or lactation - partecipation in clinical trial with sperimental drug 4 weeks before enrollment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of treatment efficacy in reducing bacterial load in sputum at visit 2 (day 7-9), visit 3 (day 14-16) and visit 4 (day 28-30);Secondary Objective: Evaluation of treatment efficacy in reducing inflammatory serum biomarkers at visit 2 (day 7-9), visit 3 (day 14-16) and visit 4 (day 28-30);Primary end point(s): Microbiological efficacy;Timepoint(s) of evaluation of this end point: visit 2,3,4
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Reduction in inflammatory serum biomarkers;Timepoint(s) of evaluation of this end point: Visit 2,3,4