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AzTrials

Pulmonary Arterial HypertensionPhase 1/2NCT02032836

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

A Phase 1/2 study testing lloprost(Ventavis,BAYQ6252, 20 µg/mL) and lloprost(Ventavis,BAYQ6252, 10 µg/mL) in people with Pulmonary Arterial Hypertension, run by Bayer at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Administration of iloprost aerosol comparing two nebulizers: FOX and I-Neb Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
lloprost(Ventavis,BAYQ6252, 20 µg/mL) and lloprost(Ventavis,BAYQ6252, 10 µg/mL)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
6 sitesin 2 countries
Study dates
10 Mar 2014to 29 Sep 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Germany5 sites

  • Study site

    Cologne, North Rhine-Westphalia, 50924

  • Study site

    Giessen, Hesse, 35392

  • Study site

    Hamburg, 20246

  • Study site

    München, Bavaria, 80639

  • Study site

    Würzburg, Bavaria, 97067

Other trials in Germany

Austria1 site

  • Study site

    Graz, Styria, 8036

Other trials in Austria

About this study

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

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

Being tested
lloprost(Ventavis,BAYQ6252, 20 µg/mL), lloprost(Ventavis,BAYQ6252, 10 µg/mL)
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lloprost(Ventavis,BAYQ6252, 20 µg/mL)Drug

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

  • lloprost(Ventavis,BAYQ6252, 10 µg/mL)Drug

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

Study groups in NCT02032836
Study groupRoleWhat they receive
I-Neb - FOXExperimentalPart 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.
Receives: Drug: lloprost(Ventavis,BAYQ6252, 20 µg/mL); Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL)
FOX - I-NebExperimentalPart 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.
Receives: Drug: lloprost(Ventavis,BAYQ6252, 20 µg/mL); Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: multiple measurements within 30 minutes after iloprost inhalation

Secondary outcomes (7)

  1. Maximum change in systolic, diastolic and mean arterial blood pressure

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

  2. Maximum change in heart rate within the 30 minutes following inhalation

    Measured: 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

    Measured: 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)

    Measured: Multiple timepoints up to 1 hour

  5. Maximum observed drug concentration in plasma after single dose administration

    Measured: 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

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

  7. half-life (associated with terminal slope)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2014 (estimated)
  2. Study start10 Mar 2014
  3. Primary completion7 Jan 2015
  4. Study completion29 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02032836
Sponsor's protocol ID
16483
Other IDs
2013-002783-12
Status last verified
Sep 2018
First submitted
9 Jan 2014
Last updated
26 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing lloprost(Ventavis,BAYQ6252, 20 µg/mL) and lloprost(Ventavis,BAYQ6252, 10 µg/mL) in people with Pulmonary Arterial Hypertension, run by Bayer at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02032836.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.

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