Pulmonary HypertensionNCT03365479
Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension
A study testing Iloprost in people with Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by University of Giessen at 2 sites in Germany.
Trial summary
Primary objective To evaluate the effect of rapid inhalation of 2.5μgiloprost using the Breelib nebulizer on pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension Secondary objectives To evaluate the effect of rapid iloprost inhalation using the Breelib nebulizer on mean pulmonary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Arterial Hypertension
- What is being tested?
- Iloprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesGermany
- Study dates
- 1 May 2017to 24 Oct 2018
- Phase
- Interventional
- 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
- Confirmed diagnosis of pulmonary arterial hypertension, WHO group 1 diagnosed according to current guidelines
- New York Heart Association functional class III
- mPAP ≥ 25 mmHg, PAWP ≤ 15 mmHg
- Age ≥ 18 years; ≤ 85 years
- planned right heart catheterization based on clinical grounds
- Stable specific PAH medications other than prostanoids
- Signed informed consent
Who cannot join
- other etiologic groups of pulmonary hypertension (WHO group 2, 3, 4, 5)
- Unstable or severe coronary artery disease (history of cardiac surgery, history of coronary intervention 2 years prior to inclusion), uncontrolled arterial hypertension, severe left ventricular hypertrophy, severe congenital or acquired valvular or myocardial disease, systolic blood pressure < 90 mmHg, heart rate of <55 or >105 beats·min-1 before inhalation
- Progressive left heart failure History of severe ventricular arrhythmias
- Pulmonary veno-occlusive disease
- Transitory ischemic attack (TIA) or stroke ≤ 3months
- Severe hepatic impairment (> CHILD B)
Show all 9Show fewer
- Severe, terminal renal impairment
- Use of intravenous, subcutaneous or oral prostacyclin/IP receptor agonists
- Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Kerckhoff-Klinik
Bad Nauheim
University Clinic Giessen and Marburg
Giessen, Hesse, 35392
About this study
Official title: Acute Hemodynamic Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension
Primary objective
- To evaluate the effect of rapid inhalation of 2.5μgiloprost using the Breelib nebulizer on pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension
Secondary objectives
- To evaluate the effect of rapid iloprost inhalation using the Breelib nebulizer on mean pulmonary arterial pressure (mPAP), cardiac output (CO), cardiac index (CI), systemic blood pressure, arterial oxygen saturation, heart rate, and pulmonary arterial wedge pressure (PAWP).
- To evaluate the safety and tolerability of the rapid iloprost inhalation using the Breelib nebulizer.
Read the detailed description
This study aims to investigate the acute hemodynamic and pharmacological effects of a single inhalation of Iloprost (2.5μg) during right heart catheterization (RHC) using the Breelib nebulizer. Patients with confirmed diagnosis of pulmonary arterial hypertension (PAH = WHO group 1), NYHA functional class III and with stable background pulmonary vasoactive treatment or treatment naïve PAH patients will be challenged with the iloprost inhalation dosage during RHC. As a proof-of concept design, the study will include consecutive PAH patients only challenged with a single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer during right heart catheterization (day 2).
The acute hemodynamic response will be followed over 30 minutes. Change of pulmonary hemodynamics, systemic blood pressure, right ventricular echocardiographic parameters and adverse events will be assessed at baseline and 5, 10, 15, 30 minutes after the end of inhalation.
Recently, the Breelib nebulizer has been evaluated within a multicenter, randomized, unblinded, study. This safety and feasibility study compared inhalation time, pharmacokinetics, and acute tolerability of inhaled iloprost delivered via Breelib versus the standard I-Neb nebulizer. The primary safety endpoints (AEs) were reported with a low frequency and were consistent with the known safety profile of iloprost. Median inhalation times were considerably shorter while maximum iloprost plasma concentration and systemic exposure were significantly higher, with Breelib versus I-Neb. Previously, it was shown that the acute hemodynamic response of iloprost inhalation via the previous used I-Neb nebulizer resulted in a relevant and significant reduction of PVR and increase in CI. Moreover, previous generation of nebulizers also resulted in a significant reduction of PVR and increase in CI 5-15min after iloprost inhalation.
Therefore, the aim of the current study is to determine the acute hemodynamic effects on the pulmonary and the systemic circulation as well as on the gas exchange of 2.5 μg iloprost delivered via the Breelib device. The investigators aim to characterize the hemodynamic profile of the inhalation with Breelib as the investigators speculate that the shortened inhalation time will result in an enhanced hemodynamic response with substantial reduction of pulmonary vascular resistance (PVR). Moreover, as a secondary outcome measurement the investigators aim to assess the response of mean pulmonary arterial pressure, cardiac index/cardiac output, systemic blood pressure, right ventricular echocardiographic parameters and oxygen saturation after inhalation of 2.5μg iloprost and analyze adverse events.
- Being tested
- Iloprost
- Keywords
- pulmonary hypertension, iloprost, inhaled, breelib, nebulizer, pulmonary arterial hypertension
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloprostDrug
Single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Experimental | The study comprises a 1-day Screening period, followed by a right heart catheterization with a single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer Receives: Drug: Iloprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of PVR (∆PVR)
Measured: 5, 10, 15, 30 minutes after the end of inhalation
Secondary outcomes (7)
Change of mPAP
Measured: at baseline and 5, 10, 15, 30 minutes after the end of inhalation
Change of PAWP
Measured: at baseline and 5, 10, 15, 30 minutes after the end of inhalation
Change of CI
Measured: at baseline and 5, 10, 15, 30 minutes after the end of inhalation
Change of systemic blood pressure
Measured: 5, 10, 15, 30 minutes after the end of inhalation
Change of oxygen saturation
Measured: 5, 10, 15, 30 minutes after the end of inhalation
Change of right heart echocardiography
Measured: 5, 10, 15, 30 minutes after the end of inhalation
Adverse events (AEs)
Measured: 5, 10, 15, 30 minutes after the end of inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 May 2017
- Primary completion1 Aug 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Grimminger, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365479
- Sponsor's protocol ID
- V04_21112017
- Status last verified
- Oct 2018
- First submitted
- 27 Nov 2017
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hemodynamic Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT03365479
- Acronym / sponsor ID
- V04_21112017
- Keywords
- pulmonary hypertension, iloprost, inhaled, breelib, nebulizer, pulmonary arterial hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective
- To evaluate the effect of rapid inhalation of 2.5μgiloprost using the Breelib nebulizer on pulmonary vascular resistance (PVR) in patients with pulmonary arterial hypertension
Secondary objectives
- To evaluate the effect of rapid iloprost inhalation using the Breelib nebulizer on mean pulmonary arterial pressure (mPAP), cardiac output (CO), cardiac index (CI), systemic blood pressure, arterial oxygen saturation, heart rate, and pulmonary arterial wedge pressure (PAWP).
- To evaluate the safety and tolerability of the rapid iloprost inhalation using the Breelib nebulizer.
Detailed description
This study aims to investigate the acute hemodynamic and pharmacological effects of a single inhalation of Iloprost (2.5μg) during right heart catheterization (RHC) using the Breelib nebulizer. Patients with confirmed diagnosis of pulmonary arterial hypertension (PAH = WHO group 1), NYHA functional class III and with stable background pulmonary vasoactive treatment or treatment naïve PAH patients will be challenged with the iloprost inhalation dosage during RHC. As a proof-of concept design, the study will include consecutive PAH patients only challenged with a single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer during right heart catheterization (day 2).
The acute hemodynamic response will be followed over 30 minutes. Change of pulmonary hemodynamics, systemic blood pressure, right ventricular echocardiographic parameters and adverse events will be assessed at baseline and 5, 10, 15, 30 minutes after the end of inhalation.
Recently, the Breelib nebulizer has been evaluated within a multicenter, randomized, unblinded, study. This safety and feasibility study compared inhalation time, pharmacokinetics, and acute tolerability of inhaled iloprost delivered via Breelib versus the standard I-Neb nebulizer. The primary safety endpoints (AEs) were reported with a low frequency and were consistent with the known safety profile of iloprost. Median inhalation times were considerably shorter while maximum iloprost plasma concentration and systemic exposure were significantly higher, with Breelib versus I-Neb. Previously, it was shown that the acute hemodynamic response of iloprost inhalation via the previous used I-Neb nebulizer resulted in a relevant and significant reduction of PVR and increase in CI. Moreover, previous generation of nebulizers also resulted in a significant reduction of PVR and increase in CI 5-15min after iloprost inhalation.
Therefore, the aim of the current study is to determine the acute hemodynamic effects on the pulmonary and the systemic circulation as well as on the gas exchange of 2.5 μg iloprost delivered via the Breelib device. The investigators aim to characterize the hemodynamic profile of the inhalation with Breelib as the investigators speculate that the shortened inhalation time will result in an enhanced hemodynamic response with substantial reduction of pulmonary vascular resistance (PVR). Moreover, as a secondary outcome measurement the investigators aim to assess the response of mean pulmonary arterial pressure, cardiac index/cardiac output, systemic blood pressure, right ventricular echocardiographic parameters and oxygen saturation after inhalation of 2.5μg iloprost and analyze adverse events.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | Experimental | Drug: IloprostThe study comprises a 1-day Screening period, followed by a right heart catheterization with a single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of pulmonary arterial hypertension, WHO group 1 diagnosed according to current guidelines
- New York Heart Association functional class III
- mPAP ≥ 25 mmHg, PAWP ≤ 15 mmHg
- Age ≥ 18 years; ≤ 85 years
- planned right heart catheterization based on clinical grounds
Key exclusion criteria (9 listed)
- other etiologic groups of pulmonary hypertension (WHO group 2, 3, 4, 5)
- Unstable or severe coronary artery disease (history of cardiac surgery, history of coronary intervention 2 years prior to inclusion), uncontrolled arterial hypertension, severe left ventricular hypertrophy, severe congenital or acquired valvular or myocardial disease, systolic blood pressure < 90 mmHg, heart rate of <55 or >105 beats·min-1 before inhalation
- Progressive left heart failure History of severe ventricular arrhythmias
- Pulmonary veno-occlusive disease
- Transitory ischemic attack (TIA) or stroke ≤ 3months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IloprostSingle administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer | Drug | Study cohort |
Primary outcome
Change of PVR (∆PVR)
Time frame: 5, 10, 15, 30 minutes after the end of inhalation
7 secondary outcomes
Change of mPAP
Time frame: at baseline and 5, 10, 15, 30 minutes after the end of inhalation
Change of PAWP
Time frame: at baseline and 5, 10, 15, 30 minutes after the end of inhalation
Change of CI
Time frame: at baseline and 5, 10, 15, 30 minutes after the end of inhalation
Change of systemic blood pressure
Time frame: 5, 10, 15, 30 minutes after the end of inhalation
Change of oxygen saturation
Time frame: 5, 10, 15, 30 minutes after the end of inhalation
Change of right heart echocardiography
Time frame: 5, 10, 15, 30 minutes after the end of inhalation
Adverse events (AEs)
Time frame: 5, 10, 15, 30 minutes after the end of inhalation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iloprost in people with Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by University of Giessen at 2 sites in Germany.
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 9 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 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
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?
Change of PVR (∆PVR) (time frame: 5, 10, 15, 30 minutes after the end of inhalation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2018.