Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03365479
• Date of registration: 27/11/2017
• Prospective Registration: No
• Primary sponsor: University of Giessen
• Public title: Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension
• Scientific title: Acute Hemodynamic Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension
• Date of first enrolment: May 1, 2017
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03365479
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- other etiologic groups of pulmonary hypertension (WHO group 2, 3, 4, 5)

- Unstable or severe coronary artery disease (history of cardiac surgery, history of
coronary intervention 2 years prior to inclusion), uncontrolled arterial hypertension,
severe left ventricular hypertrophy, severe congenital or acquired valvular or
myocardial disease, systolic blood pressure < 90 mmHg, heart rate of <55 or >105
beats·min-1 before inhalation

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Iloprost

Primary Outcome(s)

Change of PVR (?PVR) [Time Frame: 5, 10, 15, 30 minutes after the end of inhalation]

Secondary Outcome(s)

Change of systemic blood pressure [Time Frame: 5, 10, 15, 30 minutes after the end of inhalation]

Change of mPAP [Time Frame: at baseline and 5, 10, 15, 30 minutes after the end of inhalation]

Adverse events (AEs) [Time Frame: 5, 10, 15, 30 minutes after the end of inhalation]

Change of CI [Time Frame: at baseline and 5, 10, 15, 30 minutes after the end of inhalation]

Change of oxygen saturation [Time Frame: 5, 10, 15, 30 minutes after the end of inhalation]

Change of PAWP [Time Frame: at baseline and 5, 10, 15, 30 minutes after the end of inhalation]

Change of right heart echocardiography [Time Frame: 5, 10, 15, 30 minutes after the end of inhalation]

Secondary ID(s)

V04_21112017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors