NCT03365479

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2018

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

November 27, 2017

Last Update Submit

October 25, 2018

Conditions

Pulmonary HypertensionPulmonary Arterial Hypertension

Keywords

pulmonary hypertensioniloprostinhaledbreelibnebulizerpulmonary arterial hypertension

Outcome Measures

Primary Outcomes (1)

  • Change of PVR (∆PVR)

    5, 10, 15, 30 minutes after the end of inhalation

Secondary Outcomes (7)

  • Change of mPAP

    at baseline and 5, 10, 15, 30 minutes after the end of inhalation

  • Change of PAWP

    at baseline and 5, 10, 15, 30 minutes after the end of inhalation

  • Change of CI

    at baseline and 5, 10, 15, 30 minutes after the end of inhalation

  • Change of systemic blood pressure

    5, 10, 15, 30 minutes after the end of inhalation

  • Change of oxygen saturation

    5, 10, 15, 30 minutes after the end of inhalation

  • +2 more secondary outcomes

Study Arms (1)

Study cohort

EXPERIMENTAL

The study comprises a 1-day Screening period, followed by a right heart catheterization with a single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer

Drug: Iloprost

Interventions

IloprostDRUG

Single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer

Study cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of pulmonary arterial hypertension, WHO group 1 diagnosed according to current guidelines
  • New York Heart Association functional class III
  • mPAP ≥ 25 mmHg, PAWP ≤ 15 mmHg
  • Age ≥ 18 years; ≤ 85 years
  • planned right heart catheterization based on clinical grounds
  • Stable specific PAH medications other than prostanoids
  • Signed informed consent

You may not qualify if:

  • other etiologic groups of pulmonary hypertension (WHO group 2, 3, 4, 5)
  • Progressive left heart failure History of severe ventricular arrhythmias
  • Pulmonary veno-occlusive disease
  • Transitory ischemic attack (TIA) or stroke ≤ 3months
  • Severe hepatic impairment (\> CHILD B)
  • Severe, terminal renal impairment
  • Use of intravenous, subcutaneous or oral prostacyclin/IP receptor agonists
  • Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Clinic Giessen and Marburg

Giessen, Hesse, 35392, Germany

Location

Kerckhoff-Klinik

Bad Nauheim, Germany

Location

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Arterial HypertensionRespiratory Aspiration

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Chair: Ghofrani H. Ardeschir, Prof. Dr. University of Giessen

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 7, 2017

Study Start

May 1, 2017

Primary Completion

August 1, 2018

Study Completion

October 24, 2018

Last Updated

October 26, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)