Administration of iloprost aerosol comparing two nebulizers: FOX and I-Neb
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer
10 µg/mL iloprost nebulizer solution, inhaled with I-Neb nebulizer
Unnamed facility
Graz, Styria, Austria
Unnamed facility
München, Bavaria, Germany
Unnamed facility
Würzburg, Bavaria, Germany
Unnamed facility
Giessen, Hesse, Germany
Unnamed facility
The proportion of patients with a meaningful maximum increase (i.e. >=25%) in heart rate AND/OR a meaningful maximum decrease (i.e. >=20%) in systolic blood pressure within the 30 minutes after the start of inhalation
Time frame: multiple measurements within 30 minutes after iloprost inhalation
Maximum change in systolic, diastolic and mean arterial blood pressure
Time frame: From baseline to multiple BP measurements within 2 hours after iloprost inhalation
Maximum change in heart rate within the 30 minutes following inhalation
Time frame: From baseline to multiple HR measurements within 30 minutes after iloprost inhalation
Maximum change in oxygen saturation within the 30 minutes following inhalation using finger pulse oxymetry
Time frame: From baseline to multiple measurements within 30 minutes after iloprost inhalation
AUC (area under the plasma concentration curve of BAYQ6256 from zero to infinity)
Time frame: Multiple timepoints up to 1 hour
Maximum observed drug concentration in plasma after single dose administration
Time frame: Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalytics
Time to reach maximum drug observed concentration in plasma after single dose
Time frame: Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalytics
half-life (associated with terminal slope)
Time frame: Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalytics
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Cologne, North Rhine-Westphalia, Germany
Unnamed facility
Hamburg, Germany