Comparative PK PD Study in PAH Patients (Fox vs. I-Neb) | NCT02032836

NCT02032836

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2013-002783-12	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I-Neb - FOX	Experimental	Part 1: Subjects received single inhalation of 1.25 mcg iloprost using 10 mcg/ml iloprost solution (Ventavis 10) and then 2.5 mcg iloprost using Ventavis 10, both using the FOX nebulizer on Day 1. Part 2: On Day 2, subjects received single inhalation of 5 mcg iloprost using Ventavis 10 with the I-Neb nebulizer; followed by single inhalation of 5 mcg iloprost using 20 mcg/ml iloprost solution (Ventavis 20) with the FOX nebulizer in a cross-over fashion. A washout period of at least 2 hours was maintained between treatments in Part 1 and Part 2. Part 3: Continued on Day 2, and through until Day 30, subjects received multiple inhalations (approximately 6 to 9 inhalations per day) of 5 mcg iloprost using Ventavis 10 with the I-Neb nebulizer for 2 weeks; followed by multiple inhalations (approximately 6 to 9 inhalations per day) of 5 mcg iloprost using Ventavis 20 with the FOX nebulizer for 2 weeks in a cross-over fashion.	Drug: lloprost(Ventavis,BAYQ6252, 20 µg/mL) Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL)
FOX - I-Neb	Experimental	Part 1: Subjects received single inhalation of 1.25 mcg iloprost using 10 mcg/ml iloprost solution (Ventavis 10) and then 2.5 mcg iloprost using Ventavis 10, both using the FOX nebulizer on Day 1. Part 2: On Day 2, subjects received single inhalation of 5 mcg iloprost using 20 mcg/ml iloprost solution (Ventavis 20) with the FOX nebulizer; followed by single inhalation of 5 mcg iloprost using Ventavis 10 with the I-Neb nebulizer in a cross-over fashion. A wash-out period of at least 2 hours was maintained between treatments in Part 1 and Part 2. Part 3: Continued on Day 2, and through until Day 30, subjects received multiple inhalations (approximately 6 to 9 inhalations per day) of 5 mcg iloprost using Ventavis 20 with the FOX nebulizer for 2 weeks; followed by multiple inhalations (approximately 6 to 9 inhalations per day) of 5 mcg iloprost using Ventavis 10 with the I-Neb nebulizer for 2 weeks in a cross-over fashion.	Drug: lloprost(Ventavis,BAYQ6252, 20 µg/mL) Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL)

Name	Type	Description	Arm Group Labels	Other Names
lloprost(Ventavis,BAYQ6252, 20 µg/mL)	Drug	20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer	FOX - I-Neb I-Neb - FOX

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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		multiple measurements within 30 minutes after iloprost inhalation

Secondary Outcomes

Measure	Description	Time Frame
Maximum change in systolic, diastolic and mean arterial blood pressure		From baseline to multiple BP measurements within 2 hours after iloprost inhalation
Maximum change in heart rate within the 30 minutes following inhalation		From baseline to multiple HR measurements within 30 minutes after iloprost inhalation

Eligibility Module

Eligibility 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

Facility	Status	City	State	ZIP	Country	Contacts
		Graz	Styria	8036	Austria

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases