Pulmonary HypertensionPhase 1/2NCT00981591
Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients
A Phase 1/2 study testing Iloprost in people with Pulmonary Hypertension and Neonatal Hypoxic Respiratory Failure, run by Seattle Children's Hospital.
Trial summary
The purpose of this study is to determine whether inhaled iloprost is safe and effective in pediatric patients with pulmonary hypertension who are sick in the intensive care unit. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Pulmonary Hypertension, Neonatal Hypoxic Respiratory Failure, Persistent Pulmonary Hypertension of Newborn
- What is being tested?
- Iloprost
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Mar 2013
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Birth to 21 years of age
- Diagnosis of pulmonary hypertension must fit into one of three categories
- neonatal hypoxic respiratory failure
- congenital heart disease
- acquired/acute respiratory distress syndrome (lung disease)
- Parents of subject must be able and willing to give written informed consent and comply with the requirements of the study protocol and must authorize release and use of protected health information
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- Patients who remain on nitric oxide at 12 to 18 hours after initiation
- Patients who are transferred to an intensive care unit already on inhaled nitric oxide from another institution will be treated as if nitric oxide therapy was started at the time of admission to the unit
- Patients will be enrolled only after a clinical decision to treat with nitric oxide has been made by the treating physician
Who cannot join
- Corrected gestational age less than 35 weeks
- Patients with potentially fatal non-cardiopulmonary co-morbidities (e.g. hepatic, neurologic, renal)
- Known or suspected fatal genetic syndrome
- Patient with cardiac failure secondary to significant left-sided obstructive lesions
- Patient on ECMO
- Patient on any other form of prostacyclin
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- Patient on any medication with known NO production, e.g., nitroprusside
- Patient on an endothelin receptor antagonist (e.g. bosentan)
- Patient on sildenafil
- Patient on whom clinicians do not agree to follow standard inhaled nitric oxide weaning protocol
- Patients who have known hypersensitivity to prostacyclin or any of its components
- Patient who is pregnant
- Patient with platelet count less than 50,000
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Pilot Study of the Safety and Effective Dosing of Inhaled Iloprost in Pediatric Patients With Pulmonary Hypertension Treated With Inhaled Nitric Oxide
The purpose of this study is to determine whether inhaled iloprost is safe and effective in pediatric patients with pulmonary hypertension who are sick in the intensive care unit.
Read the detailed description
Inhaled nitric oxide (NO) is used in the management of all causes of pediatric pulmonary hypertension. Despite widespread use of nitric oxide to treat critically ill mechanically-ventilated pediatric patients with pulmonary hypertension, response to therapy is not universal. Nitric oxide fails to improve oxygenation in approximately 30% of these patients. Nonresponders to nitric oxide have few treatment options. Iloprost is the only other medication approved for inhalational delivery in the treatment of pulmonary hypertension. Inhalation therapy for pulmonary vasodilatation in critically ill children is inherently more attractive than oral or intravenous therapies due to the ability to deliver medication directly to the lung and to decrease systemic effects. The use of inhaled iloprost has been reported to decrease pulmonary vascular resistance in many pediatric pathologic settings, including combination therapy with nitric oxide.
- Conditions
- Pulmonary Hypertension, Neonatal Hypoxic Respiratory Failure, Persistent Pulmonary Hypertension of Newborn, Congenital Heart Defects, Acute Respiratory Distress Syndrome
- Being tested
- Iloprost, Placebo
- Keywords
- Iloprost, Nitric oxide, Mechanical ventilator
- Medical subject headings
- Hypertension, Pulmonary, Persistent Fetal Circulation Syndrome, Heart Defects, Congenital, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloprostDrug
Also called Ventavis
Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours; uptitrated to effect, to maximum dose of 30 mcg every 30 minutes
PlaceboDrug
Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Iloprost | Experimental | Not described Receives: Drug: Iloprost |
| Inhaled Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and effective dosing of inhaled iloprost in mechanically ventilated pediatric patients with pulmonary hypertension.
Measured: For the duration of time that the subject is receiving the study drug
Secondary outcomes (5)
Time to wean off iNO.
Measured: When the participant is successfully weaned off study drug
Time to extubation.
Measured: When the participant is successfully weaned off study drug
Total cost of iNO.
Measured: When the participant is successfully weaned off study drug
Incidence of rebound phenomenon, as defined by the need to return to a higher iNO dose after a previous wean.
Measured: When the participant is successfully weaned off study drug
Time to ICU discharge
Measured: When the participant is successfully weaned off study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: No patients recruited
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.
- More trials run by Seattle Children's HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion
- Responsible party
- Principal investigator, Delphine Yung, Seattle Children's Hospital
- Investigators
- Delphine Yung, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981591
- Sponsor's protocol ID
- SCIL-001-12806
- Status last verified
- Jan 2015
- First submitted
- 18 Sep 2009
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Pilot Study of the Safety and Effective Dosing of Inhaled Iloprost in Pediatric Patients With Pulmonary Hypertension Treated With Inhaled Nitric Oxide
- ClinicalTrials.gov ID
- NCT00981591
- Acronym / sponsor ID
- SCIL-001-12806
- Conditions
- Pulmonary Hypertension, Neonatal Hypoxic Respiratory Failure, Persistent Pulmonary Hypertension of Newborn, Congenital Heart Defects, Acute Respiratory Distress Syndrome
- Keywords
- Iloprost, Nitric oxide, Mechanical ventilator
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Actelion
- Study start
- Sep 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Sep 2009 (estimated)
- 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.
The purpose of this study is to determine whether inhaled iloprost is safe and effective in pediatric patients with pulmonary hypertension who are sick in the intensive care unit.
Detailed description
Inhaled nitric oxide (NO) is used in the management of all causes of pediatric pulmonary hypertension. Despite widespread use of nitric oxide to treat critically ill mechanically-ventilated pediatric patients with pulmonary hypertension, response to therapy is not universal. Nitric oxide fails to improve oxygenation in approximately 30% of these patients. Nonresponders to nitric oxide have few treatment options. Iloprost is the only other medication approved for inhalational delivery in the treatment of pulmonary hypertension. Inhalation therapy for pulmonary vasodilatation in critically ill children is inherently more attractive than oral or intravenous therapies due to the ability to deliver medication directly to the lung and to decrease systemic effects. The use of inhaled iloprost has been reported to decrease pulmonary vascular resistance in many pediatric pathologic settings, including combination therapy with nitric oxide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Iloprost | Experimental | Drug: Iloprost |
| Inhaled Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Birth to 21 years of age
- Diagnosis of pulmonary hypertension must fit into one of three categories
- Parents of subject must be able and willing to give written informed consent and comply with the requirements of the study protocol and must authorize release and use of protected health information
- Patients who remain on nitric oxide at 12 to 18 hours after initiation
- Patients who are transferred to an intensive care unit already on inhaled nitric oxide from another institution will be treated as if nitric oxide therapy was started at the time of admission to the unit
Key exclusion criteria (13 listed)
- Corrected gestational age less than 35 weeks
- Patients with potentially fatal non-cardiopulmonary co-morbidities (e.g. hepatic, neurologic, renal)
- Known or suspected fatal genetic syndrome
- Patient with cardiac failure secondary to significant left-sided obstructive lesions
- Patient on ECMO
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 |
|---|---|---|
| IloprostAlso: VentavisInhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours; uptitrated to effect, to maximum dose of 30 mcg every 30 minutes | Drug | Inhaled Iloprost |
| PlaceboInhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more | Drug | Inhaled Placebo |
Primary outcome
To determine the safety and effective dosing of inhaled iloprost in mechanically ventilated pediatric patients with pulmonary hypertension.
Time frame: For the duration of time that the subject is receiving the study drug
5 secondary outcomes
Time to wean off iNO.
Time frame: When the participant is successfully weaned off study drug
Time to extubation.
Time frame: When the participant is successfully weaned off study drug
Total cost of iNO.
Time frame: When the participant is successfully weaned off study drug
Incidence of rebound phenomenon, as defined by the need to return to a higher iNO dose after a previous wean.
Time frame: When the participant is successfully weaned off study drug
Time to ICU discharge
Time frame: When the participant is successfully weaned off study drug.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
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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.
Delphine Yung, MD principal investigator
Seattle Children's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Iloprost in people with Pulmonary Hypertension and Neonatal Hypoxic Respiratory Failure, run by Seattle Children's Hospital.
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 9 inclusion and 13 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: withdrawn, as of the sponsor's last update on 19 Jan 2015. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
To determine the safety and effective dosing of inhaled iloprost in mechanically ventilated pediatric patients with pulmonary hypertension. (time frame: For the duration of time that the subject is receiving the study drug). 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 19 Jan 2015.