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Trial intelligence / Profile preview
AIR DNase in Cystic Fibrosis
NCT02722122Phase 2
Key facts
- Status
- Unknown
- Start
- May 2016
- Primary completion
- Feb 2017
- Countries
- 1
- Sponsor
- Protalix BioTherapeutics
- Modality
- Replacement Enzymes
- Drugs
- alidornase alfa
- Conditions
- cystic fibrosis (CF)
01
Overview
Phase 2, open-label, single-arm trial of alidornase alfa in cystic fibrosis (CF), sponsored by Protalix BioTherapeutics. Primary endpoint: Adverse events following daily administration of AIR DNase™ at 56 days. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
AIR DNase 2.5 mg
2.5 mg of AIR DNase administered once daily via inhalation
03
Who it enrols
Patients aged 12 and older with Cystic Fibrosis who have been on a stable regimen of Pulmozyme (dornase alfa) for at least 4 months.
04
Endpoints
Primary
Adverse events following daily administration of AIR DNase™
Secondary
Area under the curve
Change from baseline to end of AIR DNase™ treatment in FEV1
Change from baseline to end of AIR DNase™ treatment in FVC
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