- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02032836
Comparative PK PD Study in PAH Patients (Fox vs. I-Neb)
September 25, 2018 updated by: Bayer
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
Administration of iloprost aerosol comparing two nebulizers: FOX and I-Neb
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: I-Neb - FOX
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.
|
20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer
10 µg/mL iloprost nebulizer solution, inhaled with I-Neb nebulizer
|
Experimental: FOX - I-Neb
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.
|
20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer
10 µg/mL iloprost nebulizer solution, inhaled with I-Neb nebulizer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: multiple measurements within 30 minutes after iloprost inhalation
|
multiple measurements within 30 minutes after iloprost inhalation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum change in systolic, diastolic and mean arterial blood pressure
Time Frame: From baseline to multiple BP measurements within 2 hours after iloprost inhalation
|
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
|
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
|
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
|
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
|
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
|
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
|
Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalytics
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2014
Primary Completion (Actual)
January 7, 2015
Study Completion (Actual)
September 29, 2017
Study Registration Dates
First Submitted
January 9, 2014
First Submitted That Met QC Criteria
January 9, 2014
First Posted (Estimate)
January 10, 2014
Study Record Updates
Last Update Posted (Actual)
September 26, 2018
Last Update Submitted That Met QC Criteria
September 25, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16483
- 2013-002783-12 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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