This study evaluates the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients with Cystic Fibrosis previously treated with Pulmozyme®.
This is a proof-of-concept, open label study, to evaluate the safety, tolerability, pharmacokinetics and exploratory efficacy of 2.5 mg AIR DNase TM administered once daily for 28 days via inhalation to Cystic Fibrosis subjects who have previously been treated with Pulmozyme®. This multicenter study will be conducted in approximately 10 sites and will enroll up to 15 subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Carmel MC
Haifa, Israel
RECRUITINGRambam MC
Haifa, Israel
RECRUITINGHadassah MC
Jerusalem, Israel
RECRUITINGAdverse events following daily administration of AIR DNase™
Adverse events from subject reporting or other assessments
Time frame: 56 days
Area under the curve
AIR DNase concentrations measured at 0, 0.25, 0.5, 0.75, 1, 1.5, 2, and 4 hours
Time frame: Up to 4 hours
Change from baseline to end of AIR DNase™ treatment in FEV1
Time frame: Baseline and 28 days
Change from baseline to end of AIR DNase™ treatment in FVC
Time frame: Baseline and 28 days
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Schneider MC
Petah Tikva, Israel
RECRUITINGSheba MC
Ramat Gan, Israel
RECRUITING