Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension
NCT03365479 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2018-10-26
Summary
Primary objective
• To evaluate the effect of rapid inhalation of 2.5μgiloprost using the Breelib nebulizer on pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension
Secondary objectives
* To evaluate the effect of rapid iloprost inhalation using the Breelib nebulizer on mean pulmonary arterial pressure (mPAP), cardiac output (CO), cardiac index (CI), systemic blood pressure, arterial oxygen saturation, heart rate, and pulmonary arterial wedge pressure (PAWP).
* To evaluate the safety and tolerability of the rapid iloprost inhalation using the Breelib nebulizer.
Conditions
- Pulmonary Hypertension
- Pulmonary Arterial Hypertension
Interventions
- DRUG
-
Iloprost
Single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer
Sponsors & Collaborators
-
University of Giessen
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-01
- Primary Completion
- 2018-08-01
- Completion
- 2018-10-24
Countries
- Germany
Study Locations
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