Comparative PK PD Study in PAH Patients (Fox vs. I-Neb)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02032836
• Date of registration: 09/01/2014
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Comparative PK PD Study in PAH Patients (Fox vs. I-Neb)
• Scientific title: A Multi-center, Open-label, Randomized Cross-over Study to Compare the Acute Tolerability and Pharmacokinetics of BAYQ6256 (Iloprost; Ventavis) Inhalation Using the I-Neb Nebulizer and the FOX Nebulizer in Patients With Pulmonary Arterial Hypertension
• Date of first enrolment: March 10, 2014
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02032836
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Austria, Germany

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female aged = 18 years

- Current diagnosis of pulmonary hypertension (updated Dana Point Classification 1).

- Current inhalative therapy with 5 µg iloprost using the I-Neb nebulizer

- WHO functional class III at the time of the patient's commencement of inhalative
therapy with iloprost

- Hemodynamic diagnosis of Pulmonary arterial hypertension(PAH) showing mean pulmonary
arterial pressure (mPAP) > 25 mmHg, pulmonary capillary wedge pressure (PCWP) or left
ventricular end diastolic pressure (LVEDP) < 15 mmHg and pulmonary vascular resistance
(PVR) > 320 dyn•s•cm-5

- If non-specific types of chronic treatment for PAH are being administered: Stable
dosage of these for at least the 4 weeks up to screening

- If PAH-specific drug treatments (such as endothelin receptor antagonist (ERA) or
phosphodiesterase-5 (PDE5) inhibitors) are being administered: Stable dosage of these
for at least the 3 months up to screening.

Exclusion Criteria:

- PAH related to any other etiology, especially to pulmonary veno-occlusive disease
(PVOD)

- Clinically relevant obstructive lung disease

- Evidence of thromboembolic disease (probable pulmonary embolism) within 3 years before
screening

- Cerebrovascular events within 3 months before screening

- Atrial septostomy within the 6 months before screening

- Severe arrhythmia, or severe coronary heart disease or unstable angina, or myocardial
infarction within 6 months before screening, or congenital or acquired valvular
defects with clinically relevant myocardial function disorders unrelated to PAH

- Systolic blood pressure < 85 mm Hg, or uncontrolled systemic hypertension (systolic BP
> 160 mmHg or diastolic BP > 100 mmHg)

- Hepatic impairment (Child Pugh B, C) or chronic renal insufficiency (creatinine > 2.5
mg/dl) and /or requirement of dialysis

- Clinically relevant bleedings disorders or conditions with increased risk for
hemorrhages (active ulcers, trauma etc.)

- Addition or dose change of PAH specific drug treatments such as ERA or PDE5 inhibitors
within 3 months before screening, or addition or dose change of non-specific
treatments for PAH such as calcium channel blockers, nitrates, digitalis, diuretics
within 4 weeks before Screening, or any kind of prostanoid other than those mentioned
in inclusion criteria within less than 5 half-lives before treatment



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

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL)

Drug: lloprost(Ventavis,BAYQ6252, 20 µg/mL)

Primary Outcome(s)

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]

Secondary Outcome(s)

AUC (area under the plasma concentration curve of BAYQ6256 from zero to infinity) [Time Frame: Multiple timepoints up to 1 hour]

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]

half-life (associated with terminal slope) [Time Frame: Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalytics]

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]

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]

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 observed drug concentration in plasma after single dose administration [Time Frame: Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalytics]

Secondary ID(s)

16483

2013-002783-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors