A Phase 3 interventional study of Nitric Oxide for inhalation and Oxygen in Idiopathic Pulmonary Arterial Hypertension and Cardiomyopathy, sponsored by Mallinckrodt. Completed at 18 sites in 5 countries. Open to participants aged 4 Weeks to 18 Years. Per ClinicalTrials.gov, last updated 2019-12-20.
Sponsored by Mallinckrodt · Phase 3, Interventional, and Diagnostic
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.
352 studies on the registry are indexed under Familial Primary Pulmonary Hypertension; 35 are open to participants now.
This study's enrollment of 136 is above the median of 35 across 241 interventional studies indexed under Familial Primary Pulmonary Hypertension.
Browse Familial Primary Pulmonary Hypertension studies →Mallinckrodt is the lead sponsor of 87 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must have any one of these three disease categories:
Idiopathic Pulmonary Arterial Hypertension
Congenital heart disease (CHD) with pulmonary hypertension repaired and unrepaired
Cardiomyopathy
Exclusion Criteria:
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.
Drug: Nitric Oxide for inhalation · Drug: Oxygen · Drug: Nitric Oxide plus Oxygen
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.
Drug: Nitric Oxide for inhalation · Drug: Oxygen · Drug: Nitric Oxide plus Oxygen
Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Also known as: INOmax®
100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Drug pages: Nitric Oxide · Oxygen
Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system
Also known as: Inhaled Nitric Oxide, Oxygen
Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)
A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)
Time frame: on Day 1
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: within 3 years
Children scheduled for clinically indicated right heart catheterization were screened for enrollment at 16 centers in the United States, United Kingdom, France, Spain and Netherlands.
| Milestone | Nitric Oxide First, Oxygen Last | Oxygen First, Nitric Oxide Last |
|---|---|---|
| Started | 68 | 68 |
| Completed | 62 | 59 |
| Not completed | 6 | 9 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Device failure | 0 | 1 |
| Withdrew: Physician decision | 2 | 1 |
| Withdrew: Inclusion/exclusion criteria | 3 | 6 |
A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)
| Participants | Nitric Oxide First, Oxygen Last | Oxygen First, Nitric Oxide Last |
|---|---|---|
| Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity) | 28 | 16 |
Number of participants who received surgery for pulmonary or cardiac disease within 1 year after treatment.
| Participants | Nitric Oxide First, Oxygen Last | Oxygen First, Nitric Oxide Last |
|---|---|---|
| Number of Participants With Related Surgical Procedures Within 1 Year | 44 | 21 |
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.
| Participants | Nitric Oxide First, Oxygen Last | Oxygen First, Nitric Oxide Last |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 5 | 2 |
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.
| Participants | Nitric Oxide First, Oxygen Last | Oxygen First, Nitric Oxide Last |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | 3 | 0 |
Number of participants who received surgery related to pulmonary or cardiac disease within 3 years
| Participants | Nitric Oxide First, Oxygen Last | Oxygen First, Nitric Oxide Last |
|---|---|---|
| Number of Participants With Related Surgical Procedures Within 3 Years | 12 | 6 |
Collected over within 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nitric Oxide First, Oxygen Last | — | 3/62 (4.8%) | 0/62 (0%) |
| Oxygen First, Nitric Oxide Last | — | 0/59 (0%) | 0/59 (0%) |
| Event | Nitric Oxide First, Oxygen Last | Oxygen First, Nitric Oxide Last |
|---|---|---|
| ST Segment ElevationInvestigations | 1/62 | 0/59 |
| BradycardiaCardiac disorders | 1/62 | 0/59 |
| Pulmonary HypertensionRespiratory, thoracic and mediastinal disorders | 1/62 | 0/59 |
| Cardiac ArrestCardiac disorders | 1/62 | 0/59 |
| HypotensionVascular disorders | 1/62 | 0/59 |
| Low Cardiac Output SyndromeCardiac disorders | 1/62 | 0/59 |
| Decreased oxygen saturationInvestigations | 1/62 | 0/59 |
The intent-to-treat (ITT) population was defined as all participants randomized regardless of actual receipt of treatment gas, the treatment gas actually received, or the appropriateness of their enrollment.
| Age, Categorical(Participants) | Nitric Oxide First, Oxygen Last | Oxygen First, Nitric Oxide Last | Total |
|---|---|---|---|
| <=18 years | 68 | 68 | 136 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Nitric Oxide First, Oxygen Last | Oxygen First, Nitric Oxide Last | Total |
|---|---|---|---|
| Mean | 5.9 ± 5.58 | 5.9 ± 5.58 | 5.9 ± 5.58 |
| Sex: Female, Male(Participants) | Nitric Oxide First, Oxygen Last | Oxygen First, Nitric Oxide Last | Total |
|---|---|---|---|
| Female | 34 | 34 | 68 |
| Male | 34 | 34 | 68 |
| Region of Enrollment(participants) | Nitric Oxide First, Oxygen Last | Oxygen First, Nitric Oxide Last | Total |
|---|---|---|---|
| France | 30 | 27 | 57 |
| United States | 15 | 17 | 32 |
| Spain | 12 | 12 | 24 |
| Netherlands | 5 | 6 | 11 |
| United Kingdom | 6 | 6 | 12 |
Plan to share: No
Ran from Sep 2004 to primary completion in Feb 2010, 65 months.
Results were first posted in Sep 2010, 7 months after primary completion.
Of 26 phase 3 interventional studies under Familial Primary Pulmonary Hypertension, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 95. This study's 65 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Nitric Oxide · Oxygen
Familial Primary Pulmonary Hypertension →