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Tobramycin Aerosol Pilot in Adult CF
NCT01608555Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2012
- Primary completion
- Jul 2012
- Countries
- 1
- Sponsor
- University of Milan
- Modality
- Small Molecules
- Drugs
- tobramycin
- Conditions
- cystic fibrosis (CF)
01
Overview
Phase 4, open-label, single-arm trial of tobramycin in cystic fibrosis (CF), sponsored by University of Milan. Primary endpoint: Evaluation of bacterial load decrease. Started Jan 2012; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
inhaled tobramycin once-a-day
Single dose of 300 mg tobramycin od for 28 days
03
Who it enrols
Adult outpatients (18-45 years) with cystic fibrosis, FEV1 >50% predicted, and available sputum samples. Patients must be in a stable phase.
04
Endpoints
Primary
Evaluation of bacterial load decrease
Secondary
Evaluation of inflammatory serum biomarker
Evaluation of variation in bacterial susceptibility
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