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

NCT ID: NCT02032836

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-10
• Study Completion Date: 2017-09-29

Brief Summary

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

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

lloprost(Ventavis,BAYQ6252, 20 µg/mL)

Intervention Type: DRUG

20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer

lloprost(Ventavis,BAYQ6252, 10 µg/mL)

Intervention Type: DRUG

10 µg/mL iloprost nebulizer solution, inhaled with I-Neb nebulizer

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.

Group Type: EXPERIMENTAL

lloprost(Ventavis,BAYQ6252, 20 µg/mL)

Intervention Type: DRUG

20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer

lloprost(Ventavis,BAYQ6252, 10 µg/mL)

Intervention Type: DRUG

10 µg/mL iloprost nebulizer solution, inhaled with I-Neb nebulizer

Interventions

lloprost(Ventavis,BAYQ6252, 20 µg/mL)

20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer

Intervention Type: DRUG

lloprost(Ventavis,BAYQ6252, 10 µg/mL)

10 µg/mL iloprost nebulizer solution, inhaled with I-Neb nebulizer

Intervention Type: DRUG

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Graz, Styria, Austria

München, Bavaria, Germany

Würzburg, Bavaria, Germany

Giessen, Hesse, Germany

Cologne, North Rhine-Westphalia, Germany

Hamburg, , Germany

Countries

Austria; Germany

Related Links

https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer Healthcare products.

Other Identifiers

2013-002783-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16483

Identifier Type: -

Identifier Source: org_study_id