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

NCT02032836 | Completed Phase 1

• 2 other identifiers: 164832013-002783-12
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (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

  multiple measurements within 30 minutes after iloprost inhalation

Secondary Outcomes (7)

• Maximum change in systolic, diastolic and mean arterial blood pressure

  From baseline to multiple BP measurements within 2 hours after iloprost inhalation

• Maximum change in heart rate within the 30 minutes following 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

  From baseline to multiple measurements within 30 minutes after iloprost inhalation

• AUC (area under the plasma concentration curve of BAYQ6256 from zero to infinity)

  Multiple timepoints up to 1 hour

• Maximum observed drug concentration in plasma after single dose administration

  Multiple blood sampling within 60 minutes after Ventavis inhalation and subsequent iloprost bioanalytics

Study Arms (2)

I-Neb - FOX

EXPERIMENTAL

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); Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL)

FOX - I-Neb

EXPERIMENTAL

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); Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL)

Interventions

lloprost(Ventavis,BAYQ6252, 20 µg/mL) DRUG

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

FOX - I-Neb; I-Neb - FOX

lloprost(Ventavis,BAYQ6252, 10 µg/mL) DRUG

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

FOX - I-Neb; I-Neb - FOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Bayer: lead

Study Sites (6)

Unknown Facility

Graz, Styria, 8036, Austria

Location

Unknown Facility

München, Bavaria, 80639, Germany

Location

Unknown Facility

Würzburg, Bavaria, 97067, Germany

Location

Unknown Facility

Giessen, Hesse, 35392, Germany

Location

Unknown Facility

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Unknown Facility

Hamburg, 20246, Germany

Location

Related Links

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

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 10, 2014
• Study Start: March 10, 2014
• Primary Completion: January 7, 2015
• Study Completion: September 29, 2017
• Last Updated: September 26, 2018

Record last verified: 2018-09

Locations

DE (5); AU (1)