Study Completed

pulmonary arterial hypertension

Bayer Identifier:

16483

ClinicalTrials.gov Identifier:

NCT02032836

EudraCT Number:

2013-002783-12

EU CT Number:

Not Available

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

Trial purpose

Administration of iloprost aerosol comparing two nebulizers: FOX and I-Neb

Key Participants Requirements

Sex

Both

Age

18 - N/A

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

Trial summary

Enrollment Goal

Trial Dates

March 2014 - September 2017

Phase

Phase 1/Phase 2

Could I Receive a placebo

Products

Ventavis (Iloprost, BAYQ6256)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Gießen, 35392, Germany
Completed		Hamburg, 20246, Germany
Completed		Köln, 50924, Germany
Completed		Würzburg, 97067, Germany
Completed		München, 80639, Germany
Completed		Graz, 8036, Austria

Primary Outcome

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
Safety Issue:
Yes

Secondary Outcome

Maximum change in systolic, diastolic and mean arterial blood pressure
Time Frame:
From baseline to multiple BP measurements within 2 hours after iloprost inhalation
Safety Issue:
Yes
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
Safety Issue:
Yes
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
Safety Issue:
Yes
AUC (area under the plasma concentration curve of BAYQ6256 from zero to infinity)
Time Frame:
Multiple timepoints up to 1 hour
Safety Issue:
No
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
Safety Issue:
No
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
Safety Issue:
No
half-life (associated with terminal slope)
Time Frame:
Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalytics
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

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