Overview

This trial is active, not recruiting.

Condition pulmonary arterial hypertension
Treatments lloprost(ventavis,bayq6252, 20 µg/ml), lloprost(ventavis,bayq6252, 10 µg/ml)
Phase phase 1/phase 2
Sponsor Bayer
Start date March 2014
End date January 2015
Trial size 27 participants
Trial identifier NCT02032836, 16483, 2013-002783-12

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Cross over design: First single inhalation of 5 µg iloprost using 20 µg/ml iloprost nebuliser solution with the FOX nebulizer. Then single inhalation of 5 µg iloprost using 10 µg/mL iloprost nebuliser solution with the I-Neb nebulizer. Subsequent 6 to 9 inhalations of 5 µg iloprost per day using FOX over 2 weeks, followed by 6-9 inhalations of 5 µg iloprost per day using I-Neb over 2 weeks
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
(Other)
Cross over design: First single inhalation of 5 µg iloprost using 10 µg/ml iloprost nebuliser solution with the I-Neb nebulizer. Then single inhalation of 5 µg iloprost using 20 µg/mL iloprost nebuliser solution with the FOX nebulizer. Subsequent 6 to 9 inhalations of 5 µg iloprost per day using I-Neb over 2 weeks, followed by 6-9 inhalations of 5 µg iloprost per day using Fox over 2 weeks
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

Primary Outcomes

Measure
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 Outcomes

Measure
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 change in heart rate within the 30 minutes following inhalation
time frame: From baseline to multiple HR measurements within 30 minutes after iloprost inhalation
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
AUC (area under the plasma concentration curve of BAYQ6256 from zero to infinity)
time frame: Multiple timepoints up to 1 hour
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
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
half-life (associated with terminal slope)
time frame: Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalytics

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bayer.