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

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ClinicalTrials.gov Identifier: NCT02032836
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: lloprost(Ventavis,BAYQ6252, 20 µg/mL) Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 10, 2014
Actual Primary Completion Date : January 7, 2015
Actual Study Completion Date : September 29, 2017


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.
Drug: lloprost(Ventavis,BAYQ6252, 20 µg/mL)
20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer

Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL)
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.
Drug: lloprost(Ventavis,BAYQ6252, 20 µg/mL)
20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Maximum change in systolic, diastolic and mean arterial blood pressure [ Time Frame: From baseline to multiple BP measurements within 2 hours after iloprost inhalation ]
  2. 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 ]
  3. 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 ]
  4. AUC (area under the plasma concentration curve of BAYQ6256 from zero to infinity) [ Time Frame: Multiple timepoints up to 1 hour ]
  5. 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 ]
  6. 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 ]
  7. half-life (associated with terminal slope) [ Time Frame: Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalytics ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032836


Locations
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Austria
Graz, Steiermark, Austria, 8036
Germany
München, Bayern, Germany, 80639
Würzburg, Bayern, Germany, 97067
Gießen, Hessen, Germany, 35392
Köln, Nordrhein-Westfalen, Germany, 50924
Hamburg, Germany, 20246
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02032836     History of Changes
Other Study ID Numbers: 16483
2013-002783-12 ( EudraCT Number )
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Iloprost
Pharmaceutical Solutions
Platelet Aggregation Inhibitors
Vasodilator Agents