Pulmonary HypertensionPhase 4NCT02170519

Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide

A Phase 4 study testing Inhaled Iloprost in people with Pulmonary Hypertension, run by Duke University.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 1 year to 90 years
Conditions the study is for: Pulmonary Hypertension
What is being tested?: Inhaled Iloprost
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: No sites listed yet
Study dates: Sep 2006to Jan 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 year to 90 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed by the attending physician.
Indwelling arterial catheter.
Signed informed consent

Who cannot join

Clinically unstable circulatory condition requiring epinephrine > 0.1 mcg/kg/min or levophed, or already meeting treatment failure criteria (see section 5.3 below)
Known hypersensitivity to prostacyclin compounds
Patients receiving sildenafil or bosentan
Refusal by the attending physician

About this study

Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this condition. The evidence supporting INO safety and efficacy under these circumstances is sparse, however, and is largely extrapolated from the use of INO in neonatal pulmonary hypertension. Moreover, the high cost and potential toxicity of INO makes the therapy far from ideal. Emerging evidence suggests that inhaled aerosolized prostacyclins such as iloprost may be a favorable alternative therapy.

Read the detailed description

Phase 1- In the original study, 3 doses of Iloprost were given. This was revised after 5 subjects were enrolled in order to study the effects of continuous delivery over a longer period of time.

Phase 2 - All remaining subjects received Iloprost as a continuous treatment.

The study was designed for an enrollment of 200 subjects and was ended early.

Conditions: Pulmonary Hypertension
Being tested: Inhaled Iloprost
Keywords: pulmonary hypertension
Medical subject headings: Hypertension, Pulmonary

What participants receive

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

Inhaled IloprostDrug
Also called Ventavis
A 20 mcg dose of Iloprost will be given initially.

Study groups in NCT02170519
Study group	Role	What they receive
Phase 2: Inhaled Iloprost continuous	Experimental	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. Receives: Drug: Inhaled Iloprost
Phase 1: Inhaled Iloprost 3 doses	Experimental	Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose. Receives: Drug: Inhaled Iloprost

What is being measured

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

Percent Change in Oxygen Saturation (SpO2) From Baseline
Readings were taken from the medical record and the data may not have been present at the exact time frames.
Measured: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Percent Change in Oxygen Saturation (SpO2) From Baseline
Measured: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Change in Mean Heart Rate From Baseline
Measured: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Mean Heart Rate From Baseline
Measured: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Number of Treatment Failures
Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following:
1. Cardiac Index (CI) >/= 1.8 L/min/m2
2. Administration of >/=0.1 ug/kg/min Epinephrine or Norepinephrine
3. MAP </= 50 mmHg (or as appropriate for age in pediatrics).
4. SvO2</= 55% (or < 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}
Measured: as long as subject was on drug up to approximately 24 hours
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
Measured: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
Measured: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)

Secondary outcomes (4)

Change in Cardiac Output (CO) From Baseline
Measured: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Cardiac Output (CO) From Baseline
Measured: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.
Measured: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
Measured: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)

Timeline

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

Sep 2006Jan 2009

First posted23 Jun 2014 (estimated)
Study startSep 2006
Primary completionJan 2009
Study completionJan 2009

Why it stopped: Project was completed

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02170519
Sponsor's protocol ID: Pro00013737
Status last verified: Jun 2014
First submitted: 19 Jun 2014
Last updated: 15 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
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RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
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Study of Intravenous ZMA001 in Healthy Subjects
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All Pulmonary Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
ClinicalTrials.gov ID: NCT02170519
Acronym / sponsor ID: Pro00013737
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Project was completed
Enrolment: 27 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: Sep 2006
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 23 Jun 2014 (estimated)
Results: Posted 26 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Phase 1- In the original study, 3 doses of Iloprost were given. This was revised after 5 subjects were enrolled in order to study the effects of continuous delivery over a longer period of time.

Phase 2 - All remaining subjects received Iloprost as a continuous treatment.

The study was designed for an enrollment of 200 subjects and was ended early.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Phase 2: Inhaled Iloprost continuous	Experimental	Drug: Inhaled IloprostEach subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.
Phase 1: Inhaled Iloprost 3 doses	Experimental	Drug: Inhaled IloprostEach subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.

Who may qualify

Ages: 1 year to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed by the attending physician.
Indwelling arterial catheter.
Signed informed consent

Key exclusion criteria (4 listed)

Clinically unstable circulatory condition requiring epinephrine > 0.1 mcg/kg/min or levophed, or already meeting treatment failure criteria (see section 5.3 below)
Known hypersensitivity to prostacyclin compounds
Patients receiving sildenafil or bosentan
Refusal by the attending physician

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
Inhaled IloprostAlso: VentavisA 20 mcg dose of Iloprost will be given initially.	Drug	Phase 1: Inhaled Iloprost 3 doses, Phase 2: Inhaled Iloprost continuous

Primary outcome

Percent Change in Oxygen Saturation (SpO2) From Baseline
Time frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Readings were taken from the medical record and the data may not have been present at the exact time frames.
Percent Change in Oxygen Saturation (SpO2) From Baseline
Time frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Change in Mean Heart Rate From Baseline
Time frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Mean Heart Rate From Baseline
Time frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Number of Treatment Failures
Time frame: as long as subject was on drug up to approximately 24 hours
Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following: 1. Cardiac Index (CI) >/= 1.8 L/min/m2 2. Administration of >/=0.1 ug/kg/min Epinephrine or Norepinephrine 3. MAP </= 50 mmHg (or as appropriate for age in pediatrics). 4. SvO2</= 55% (or < 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
Time frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
Time frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)

4 secondary outcomes

Change in Cardiac Output (CO) From Baseline
Time frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Cardiac Output (CO) From Baseline
Time frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
Time frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
Time frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)

Results and safety

Results posted to the registry on 26 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 2: Inhaled Iloprost Continuous	22	22
Phase 1: Inhaled Iloprost 3 Doses	5	5

Primary outcome: Percent Change in Oxygen Saturation (SpO2) From Baseline

Time frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours. Mean (Standard Deviation). Unit: percent change

Measure	Phase 2: Inhaled Iloprost Continuous n = 22
30 mins after initial dose	-0.4 (1.7)
2 hours	-0.8 (2.8)
4 hours	-1.2 (2.9)
6 hours	-0.2 (3.6)
8 hours	-0.7 (3.1)
10 hours	-0.9 (3.0)
12 hours	-0.9 (3.7)
18 hours	-1.5 (5.6)

Population analysed: Phase 2 subjects

Primary outcome: Percent Change in Oxygen Saturation (SpO2) From Baseline

Time frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour). Mean (Standard Deviation). Unit: percent change

Measure	Phase 1: Inhaled Iloprost 3 Doses n = 5
dose 1	-0.4 (0.6)
dose 2	-0.4 (1.6)
dose 3	0.0 (2.9)
combined therapy	0.2 (2.4)
end INO	0.4 (1.6)

Population analysed: Phase 1 subjects

Primary outcome: Change in Mean Heart Rate From Baseline

Time frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours. Mean (Standard Deviation). Unit: percent change

Measure	Phase 2: Inhaled Iloprost Continuous n = 22
30 mins after initial dose	-1.8 (4.4)
2 hours	-1.1 (6.6)
4 hours	4.2 (18.7)
6 hours	0.8 (12.5)
8 hours	-1.0 (13.7)
10 hours	2.2 (14.3)
12 hours	-2.9 (12.0)
18 hours	-4.0 (12.6)

Population analysed: Phase 2 subjects

Primary outcome: Change in Mean Heart Rate From Baseline

Time frame: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour). Mean (Standard Deviation). Unit: percent change

Measure	Phase 1: Inhaled Iloprost 3 Doses n = 5
dose 1	0.9 (4.8)
dose 2	2.5 (4.5)
dose 3	0.7 (6.7)
combined therapy	0.9 (7.8)
end INO	-0.2 (8.9)

Population analysed: Phase 1 subjects

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 2: Inhaled Iloprost Continuous	0 of 22 (0%)	0 of 22 (0%)	Not reported
Phase 1: Inhaled Iloprost 3 Doses	0 of 5 (0%)	0 of 5 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pulmonary Hypertension

Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Not yet recruitingPhase 2
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Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
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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.

Neil MacIntyre, MD principal investigator

Duke University

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inhaled Iloprost in people with Pulmonary Hypertension, run by Duke University.

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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change in Oxygen Saturation (SpO2) From Baseline (time frame: 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours). The study lists 7 primary outcomes in all. 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 NCT02170519.

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 15 Oct 2024.