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

• Status: Completed
• Trial end date: 2017-09-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Iloprost; Pharmaceutical Solutions

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