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Prolastin in Cystic Fibrosis
NCT02010411Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2004
- Primary completion
- Oct 2004
- Countries
- 1
- Sponsor
- Université de Sherbrooke
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- cystic fibrosis (CF)
01
Overview
Phase 2, open-label, single-arm trial of alpha-1-proteinase inhibitor in cystic fibrosis (CF), sponsored by Université de Sherbrooke. Primary endpoint: Bacterial density in sputum at 6 hours. Started Jun 2004; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Prolastin
All subjects receive saline aerosol therapy followed by Prolastin aerosol therapy in a crossover design.
03
Who it enrols
Patients aged 14 and older with cystic fibrosis, able to produce sputum, and with a sputum culture positive for Pseudomonas aeruginosa.
04
Endpoints
Primary
Bacterial density in sputum
Secondary
Neutrophil burden in airways
Sputum elastase activity
Alpha1 antitrypsin in sputum
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