Idiopathic Pulmonary Arterial HypertensionPhase 3NCT00626028
Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
A Phase 3 study testing Nitric Oxide for inhalation, Oxygen and Nitric Oxide plus Oxygen in people with Idiopathic Pulmonary Arterial Hypertension and Cardiomyopathy, run by Mallinckrodt at 18 sites in 5 countries.
Trial summary
The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen. Read more about this study
- Who is it for?
- Ages 4 weeks to 18 years
- Conditions the study is for
- Idiopathic Pulmonary Arterial Hypertension, Cardiomyopathy
- What is being tested?
- Nitric Oxide for inhalation, Oxygen and Nitric Oxide plus Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 18 sitesin 5 countries
- Study dates
- Sep 2004to Feb 2010
- Phase
- Phase 3
- 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 4 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Must have any one of these three disease categories:
- Idiopathic Pulmonary Arterial Hypertension
- Mean pulmonary arterial pressure (PAPm) > 25 millimeters of mercury (mmHg) at rest, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and PVRI> 3 u•m^2 or diagnosed clinically with no previous catheterization
- Congenital heart disease (CHD) with pulmonary hypertension repaired and unrepaired
- PAPm > 25 mmHg at rest and PVRI> 3 u•m^2 or diagnosed clinically with no previous catheterization
- Cardiomyopathy
Show all 10Show fewer
- PAPm > 25 mmHg at rest and Pulmonary vascular resistance index (PVRI)> 3 u•m^2 or diagnosed clinically with no previous catheterization
- Scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing.
- Male or female, ages 4 weeks to 18 years, inclusive
- Signed informed consent/assent
Who cannot join
- Focal pulmonary infiltrates on chest radiograph.
- Diagnosed with severe obstructive or restrictive pulmonary disease that is significantly contributing to the patient's pulmonary hypertension.
- Received treatment with nitric oxide for inhalation within 30 days prior to study initiation, are on other investigational medications, nitroglycerin, sodium nitroprusside, sildenafil, other Phosphodiesterase type 5 (PDE-5) inhibitors, or prostacyclin
- Pregnant [urine human chorionic gonadotropin positive (HCG +)]
- Baseline Pulmonary capillary wedge pressure (PCWP) > 20 mmHg
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
United States8 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
The Medical University of South Carolina
Charleston, South Carolina, 29425
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Columbus Children's Hospital
Columbus, Ohio, 43205
The Children's Hospital
Denver, Colorado, 80218
New York Presbyterian Hospital
New York, New York, 10032
St. Louis Children's Hospital
St Louis, Missouri, 63110
Lucile Salter Packard Children's Hospital at Stanford
Stanford, California, 94304
Spain4 sites
Hospital Sant Joan de Déu de Barcelona
Barcelona
Unidad de Cardiologia Infantil - Hospital Vall d'Hebrón
Barcelona
Hospital Gregorio Maranon
Madrid
Instituto Pediátrico del Corazón - Hospital Materno Infatil Doce de Octubre
Madrid
France3 sites
CHU Timone - Département de cardiologie
Marseille
Hôpital d'Enfants
Nancy
Hôpital NECKER - Enfants Malades
Paris
United Kingdom2 sites
Royal Brompton Hospital
London
Southampton University Hospitals Trust - Wessex Cardiothoracic Centre
Southampton
Netherlands1 site
Beatrix Children's Hospital / University Hospital Groningen
Groningen
About this study
Official title: Comparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator Testing
The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.
- Being tested
- Nitric Oxide for inhalation, Oxygen, Nitric Oxide plus Oxygen
- Keywords
- Pulmonary Vasculature, Nitric Oxide, INOmax®, Acute Lung Injury, Pulmonary Vasodilator Testing, Idiopathic Pulmonary Arterial Hypertension, Congenital Heart Disease, reversible pulmonary hypertension, vasoreactivity, Congenital Heart Disease with Pulmonary Hypertension
- Medical subject headings
- Familial Primary Pulmonary Hypertension, Cardiomyopathies, Acute Lung Injury, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide for inhalationDrug
Also called INOmax®
Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
OxygenDrug
100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Nitric Oxide plus OxygenDrug
Also called Inhaled Nitric Oxide, Oxygen
Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system
| Study group | Role | What they receive |
|---|---|---|
| Nitric Oxide First, Oxygen Last | Experimental | 10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1. Receives: Drug: Nitric Oxide for inhalation; Drug: Oxygen; Drug: Nitric Oxide plus Oxygen |
| Oxygen First, Nitric Oxide Last | Experimental | 10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1. Receives: Drug: Nitric Oxide for inhalation; Drug: Oxygen; Drug: Nitric Oxide plus Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)
A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)
Measured: on Day 1
Secondary outcomes (4)
Number of Participants With Related Surgical Procedures Within 1 Year
Number of participants who received surgery for pulmonary or cardiac disease within 1 year after treatment.
Measured: within 1 year
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence. An AE need not have a causal relationship with treatment and included any event that was not seen at baseline or, if present at baseline, increased in severity.
Measured: on Day 1
Number of Participants With Serious Adverse Events (SAEs)
SAEs were collected during the 12 hours after discontinuation of gas or discharge (whichever came first). An SAE was defined as any event that resulted in death, was life threatening, resulted in permanent disability or incapacity, required or prolonged inpatient hospitalization, or was a congenital anomaly. Important medical events that, without medical or surgical intervention, would also have resulted in one of the outcomes listed above were also considered as SAEs.
Measured: within 12 hours
Number of Participants With Related Surgical Procedures Within 3 Years
Number of participants who received surgery related to pulmonary or cardiac disease within 3 years
Measured: within 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startSep 2004
- Primary completionFeb 2010
- Study completionFeb 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary Arterial 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, MD, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626028
- Sponsor's protocol ID
- INOT22
- Other IDs
- 2004-000625-30, 2004
- Status last verified
- Sep 2016
- First submitted
- 20 Feb 2008
- Last updated
- 20 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barst RJ, Agnoletti G, Fraisse A, Baldassarre J, Wessel DL; NO Diagnostic Study Group. Vasodilator testing with nitric oxide and/or oxygen in pediatric pulmonary hypertension. Pediatr Cardiol. 2010 Jul;31(5):598-606. doi: 10.1007/s00246-010-9645-5. Epub 2010 Apr 20.
PubMed 20405117
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Supplemental Oxygen and Nitric Oxide for Inhalation Plus Oxygen in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator Testing
- ClinicalTrials.gov ID
- NCT00626028
- Acronym / sponsor ID
- INOT22
- Keywords
- Pulmonary Vasculature, Nitric Oxide, INOmax®, Acute Lung Injury, Pulmonary Vasodilator Testing, Idiopathic Pulmonary Arterial Hypertension, Congenital Heart Disease, reversible pulmonary hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Sep 2004 (actual)
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Posted 16 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide First, Oxygen Last | Experimental | Drug: Nitric Oxide for inhalation, Drug: Oxygen, Drug: Nitric Oxide plus Oxygen10 minute dose of Nitric Oxide (NO) at 80 ppm, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of 100% Oxygen on Day 1. |
| Oxygen First, Nitric Oxide Last | Experimental | Drug: Nitric Oxide for inhalation, Drug: Oxygen, Drug: Nitric Oxide plus Oxygen10 minute dose of 100% Oxygen, then 10 minute dose of NO plus Oxygen, then 10 minute washout, then 10 minute dose of NO at 80 ppm on Day 1. |
Who may qualify
- Ages
- 4 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Must have any one of these three disease categories:
- Scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing.
- Male or female, ages 4 weeks to 18 years, inclusive
- Signed informed consent/assent
Key exclusion criteria (5 listed)
- Focal pulmonary infiltrates on chest radiograph.
- Diagnosed with severe obstructive or restrictive pulmonary disease that is significantly contributing to the patient's pulmonary hypertension.
- Received treatment with nitric oxide for inhalation within 30 days prior to study initiation, are on other investigational medications, nitroglycerin, sodium nitroprusside, sildenafil, other Phosphodiesterase type 5 (PDE-5) inhibitors, or prostacyclin
- Pregnant [urine human chorionic gonadotropin positive (HCG +)]
- Baseline Pulmonary capillary wedge pressure (PCWP) > 20 mmHg
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 |
|---|---|---|
| Nitric Oxide for inhalationAlso: INOmax®Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system | Drug | Nitric Oxide First, Oxygen Last, Oxygen First, Nitric Oxide Last |
| Oxygen100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system | Drug | Nitric Oxide First, Oxygen Last, Oxygen First, Nitric Oxide Last |
| Nitric Oxide plus OxygenAlso: Inhaled Nitric Oxide, OxygenNitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system | Drug | Nitric Oxide First, Oxygen Last, Oxygen First, Nitric Oxide Last |
Primary outcome
Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)
Time frame: on Day 1
A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)
4 secondary outcomes
Number of Participants With Related Surgical Procedures Within 1 Year
Time frame: within 1 year
Number of Participants With Adverse Events (AEs)
Time frame: on Day 1
Number of Participants With Serious Adverse Events (SAEs)
Time frame: within 12 hours
Number of Participants With Related Surgical Procedures Within 3 Years
Time frame: within 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20405117Barst RJ, Agnoletti G, Fraisse A, Baldassarre J, Wessel DL; NO Diagnostic Study Group. Vasodilator testing with nitric oxide and/or oxygen in pediatric pulmonary hypertension. Pediatr Cardiol. 2010 Jul;31(5):598-606. doi: 10.1007/s00246-010-9645-5. Epub 2010 Apr 20.
- 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.
Global Clinical Leader, MD study director
Mallinckrodt
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitric Oxide for inhalation, Oxygen and Nitric Oxide plus Oxygen in people with Idiopathic Pulmonary Arterial Hypertension and Cardiomyopathy, run by Mallinckrodt at 18 sites in 5 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 10 inclusion and 5 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 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Spain, France, United Kingdom, Netherlands. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Sep 2010). 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?
Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity) (time frame: on Day 1). 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 NCT00626028, which also lists 1 linked publication.
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 20 Dec 2019.