Ignite Creation Date:
2024-05-06 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03365479
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2017-11-27
Brief Title:
Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension
Sponsor:
University of Giessen
Organization:
University of Giessen
Study Overview
Official Title:
Acute Hemodynamic Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective
To evaluate the effect of rapid inhalation of 25μgiloprost 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
To evaluate the effect of rapid inhalation of 25μgiloprost 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
Detailed Description:
This study aims to investigate the acute hemodynamic and pharmacological effects of a single inhalation of Iloprost 25μg during right heart catheterization RHC using the Breelib nebulizer Patients with confirmed diagnosis of pulmonary arterial hypertension PAH WHO group 1 NYHA functional class III and with stable background pulmonary vasoactive treatment or treatment naïve PAH patients will be challenged with the iloprost inhalation dosage during RHC As a proof-of concept design the study will include consecutive PAH patients only challenged with a single administration of inhaled iloprost 25 μg delivered via Breelib nebulizer during right heart catheterization day 2
The acute hemodynamic response will be followed over 30 minutes Change of pulmonary hemodynamics systemic blood pressure right ventricular echocardiographic parameters and adverse events will be assessed at baseline and 5 10 15 30 minutes after the end of inhalation
Recently the Breelib nebulizer has been evaluated within a multicenter randomized unblinded study This safety and feasibility study compared inhalation time pharmacokinetics and acute tolerability of inhaled iloprost delivered via Breelib versus the standard I-Neb nebulizer The primary safety endpoints AEs were reported with a low frequency and were consistent with the known safety profile of iloprost Median inhalation times were considerably shorter while maximum iloprost plasma concentration and systemic exposure were significantly higher with Breelib versus I-Neb Previously it was shown that the acute hemodynamic response of iloprost inhalation via the previous used I-Neb nebulizer resulted in a relevant and significant reduction of PVR and increase in CI Moreover previous generation of nebulizers also resulted in a significant reduction of PVR and increase in CI 5-15min after iloprost inhalation
Therefore the aim of the current study is to determine the acute hemodynamic effects on the pulmonary and the systemic circulation as well as on the gas exchange of 25 μg iloprost delivered via the Breelib device The investigators aim to characterize the hemodynamic profile of the inhalation with Breelib as the investigators speculate that the shortened inhalation time will result in an enhanced hemodynamic response with substantial reduction of pulmonary vascular resistance PVR Moreover as a secondary outcome measurement the investigators aim to assess the response of mean pulmonary arterial pressure cardiac indexcardiac output systemic blood pressure right ventricular echocardiographic parameters and oxygen saturation after inhalation of 25μg iloprost and analyze adverse events
The acute hemodynamic response will be followed over 30 minutes Change of pulmonary hemodynamics systemic blood pressure right ventricular echocardiographic parameters and adverse events will be assessed at baseline and 5 10 15 30 minutes after the end of inhalation
Recently the Breelib nebulizer has been evaluated within a multicenter randomized unblinded study This safety and feasibility study compared inhalation time pharmacokinetics and acute tolerability of inhaled iloprost delivered via Breelib versus the standard I-Neb nebulizer The primary safety endpoints AEs were reported with a low frequency and were consistent with the known safety profile of iloprost Median inhalation times were considerably shorter while maximum iloprost plasma concentration and systemic exposure were significantly higher with Breelib versus I-Neb Previously it was shown that the acute hemodynamic response of iloprost inhalation via the previous used I-Neb nebulizer resulted in a relevant and significant reduction of PVR and increase in CI Moreover previous generation of nebulizers also resulted in a significant reduction of PVR and increase in CI 5-15min after iloprost inhalation
Therefore the aim of the current study is to determine the acute hemodynamic effects on the pulmonary and the systemic circulation as well as on the gas exchange of 25 μg iloprost delivered via the Breelib device The investigators aim to characterize the hemodynamic profile of the inhalation with Breelib as the investigators speculate that the shortened inhalation time will result in an enhanced hemodynamic response with substantial reduction of pulmonary vascular resistance PVR Moreover as a secondary outcome measurement the investigators aim to assess the response of mean pulmonary arterial pressure cardiac indexcardiac output systemic blood pressure right ventricular echocardiographic parameters and oxygen saturation after inhalation of 25μg iloprost and analyze adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None