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• Register: EUCTR
• Last refreshed on: 20 August 2018
• Main ID: EUCTR2013-002783-12-DE
• Date of registration: 18/09/2013
• Prospective Registration: Yes
• Primary sponsor: Bayer HealthCare AG
• Public title: No
• Scientific title: A multi-center, open-label, randomized cross-over study to compare the acute tolerability and pharmacokinetics of BAY Q 6256 (iloprost; Ventavis) inhalation using the I-Neb nebulizer and the FOX nebulizer in patients with pulmonary arterial hypertension - Administration von Iloprost aerosol comparing two nebulizers: Fox and I-Neb
• Date of first enrolment: 07/01/2014
• Target sample size: 24
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002783-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: yes; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: Ventavis 10 or Ilomedin 20µg/ml will be administered with the I-Neb and the Fox nebulizer; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Germany

Contacts

• Name: Bayer Clinical Trial Contact
• Affiliation: Bayer HealthCare AG

• Name: Bayer Clinical Trial Contact
• Affiliation: Bayer HealthCare AG

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female aged = 18 years.
2. Written informed consent given. [This consent must have been given before any study-specific procedures are conducted. A single informed consent form will cover both the main study, Parts 1–3, and the extension, Part 4.]
3. Current diagnosis of pulmonary hypertension (updated Dana Point Classification 1).
4. Current inhalative therapy with 5 µg iloprost using the I Neb nebulizer.
5. WHO functional class III at the time of the patient's commencement of inhalative therapy with iloprost.
6. Hemodynamic diagnosis of 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.
7. Ability to understand and follow study-related instructions.
8. 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.
9. 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion criteria:
Related to pulmonary disease / PAH
1. PAH related to any etiology other than those specified in the inclusion criteria, especially pulmonary veno-occlusive disease (PVOD)
2. Documented evidence of thromboembolic disease (probability for pulmonary embolism) using methodology such as pulmonary angiogram, ventilation perfusion scan, or chest computed tomography (CT) scan within the 3 years before the screening visit
3. Clinically relevant obstructive lung disease (e.g. asthma or chronic obstructive pulmonary disease, COPD)
4. Receipt of atrial septostomy within the six months before the screening visit
Related to cardiovascular disease
5. Severe coronary heart disease or unstable angina
6. Myocardial infarction within the six months before the screening visit
7. Decompensated cardiac failure if not under close medical supervision
8. Severe arrhythmias
9. Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
10. Cerebrovascular events (e.g. transient ischemic attack or stroke) within 3 months before Screening Visit
11. Uncontrolled systemic hypertension as evidenced by systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement
12. Systemic hypotension with systolic blood pressure < 85 mmHg
Related to other conditions
13. Hypersensitivity to the active substance or to any of the excipients
14. Conditions where the effects of Ventavis on platelets might increase the risk of hemorrhage (e.g. active peptic ulcers, trauma, intracranial hemorrhage)
15. Hepatic impairment (such as acute hepatitis, chronic active hepatitis, or liver cirrhosis Child-Pugh B, C)
16. Chronic renal insufficiency as defined by a creatinine of > 2.5 mg/dL and/or the requirement for dialysis
17. Clinically relevant bleeding disorder or active bleeding
18. Psychiatric, addictive, or other disorder that compromises the ability to give informed consent for participating in this study
19. Clinically relevant abnormal conditions (including laboratory values) at Screening Visit that, in the opinion of the investigator, would compromise the evaluation of the study drug
Related to prior and concomitant medication
20. Addition or dose change of PAH specific drug treatments such as ERA or PDE5 inhibitors within 3 months before Screening Visit
21. Addition or dose change of non-specific type of chronic treatments for PAH such as calcium channel blockers, nitrates, digitalis, or diuretics within 4 weeks before Screening Visit
22. Treatment with an investigational drug or device which has not received regulatory approval within 4 weeks before Screening Visit or during study
23. Any kind of prostanoid other than those mentioned in inclusion criteria no. 9 within a period shorter than 5 half-lives before treatment
Others
24. Pregnant or breastfeeding women
25. Woman of child-bearing potential does not agree to use an adequate method of contraception, i.e. a combination of two effective methods of birth control, for example a combination of condoms with a safe and highly effective contraception method (prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) or a double barrier method is used throughout the study
26. Investigators, study staff, or their immediate families
27. Criteria which in the opinion of the investigator preclude participation for scientific reason

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with Pulmonary arterial hypertension, WHO class III, who have been on therpay with Ventavis 10 for at least 4 weeks
MedDRA version: 16.1 Level: LLT Classification code 10036727 Term: Primary pulmonary hypertension System Organ Class: 100000004855

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Trade Name: Ventavis 10
Product Name: Ventavis 10
Product Code: Bay Q 6256
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: ILOPROST
CAS Number: 78919-13-8
Current Sponsor code: Bay q 6256
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Ilomedin 20 [20 µg / ml]
Product Name: Ilomedin 20
Product Code: Bay q 6256
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: ILOPROST
CAS Number: 78919-13-8
Current Sponsor code: Bay q 6256
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: within 30 minutes after start of inhalation

Secondary Objective: The secondary objective is to compare the pharmacokinetics of iloprost as administered by these two methods

Primary end point(s): The primary analysis in this study is of safety.
The primary safety variable is:
– 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.

Main Objective: The primary objective of this study is to assess, in subjects with pulmonary arterial hypertension, the acute tolerability of 5 µg iloprost inhaled as Ventavis 20 µg/mL solution through a FOX nebulizer with that of 5 µg iloprost inhaled as Ventavis 10 µg/mL solution through the I Neb nebulizer.

Secondary Outcome(s)

Secondary end point(s): The secondary safety variables are:
– Maximum change in systolic, diastolic and mean arterial blood pressure,
– Maximum change in heart rate within the 30 minutes following inhalation,
– Maximum change in oxygen saturation within the 30 minutes following inhalation.

- Pharmacokinetics of Iloprost as administered by two inhalers (Fox and I-Neb)

Timepoint(s) of evaluation of this end point: up to 2 hours after start of each inhalation

Secondary ID(s)

BAYq6256/16483

Source(s) of Monetary Support

Bayer HealthCare AG