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

Pulmonary Arterial Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032836
• Other study ID #: 16483
• Secondary ID: 2013-002783-12
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 10, 2014
• Est. completion date: September 29, 2017

Study information

• Verified date: September 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 29, 2017
• Est. primary completion date: January 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• lloprost(Ventavis,BAYQ6252, 20 µg/mL)
20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer
• lloprost(Ventavis,BAYQ6252, 10 µg/mL)
10 µg/mL iloprost nebulizer solution, inhaled with I-Neb nebulizer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum change in systolic, diastolic and mean arterial blood pressure		From baseline to multiple BP measurements within 2 hours after iloprost inhalation
Secondary	Maximum change in heart rate within the 30 minutes following inhalation		From baseline to multiple HR measurements within 30 minutes after iloprost inhalation
Secondary	Maximum change in oxygen saturation within the 30 minutes following inhalation using finger pulse oxymetry		From baseline to multiple measurements within 30 minutes after iloprost inhalation
Secondary	AUC (area under the plasma concentration curve of BAYQ6256 from zero to infinity)		Multiple timepoints up to 1 hour
Secondary	Maximum observed drug concentration in plasma after single dose administration		Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalytics
Secondary	Time to reach maximum drug observed concentration in plasma after single dose		Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalytics
Secondary	half-life (associated with terminal slope)		Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalytics

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