Trial Outcomes & Findings for Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing (NCT NCT00626028)
NCT ID: NCT00626028
Last Updated: 2019-12-20
Results Overview
A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)
COMPLETED
PHASE3
136 participants
on Day 1
2019-12-20
Participant Flow
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.
All 136 patients screened received all three study drugs in a crossover design, serving as their own controls. They were randomized 1:1 into two treatment sequences.
Participant milestones
| Measure |
Nitric Oxide First, Oxygen Last
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.
|
Oxygen First, Nitric Oxide Last
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.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
|
Overall Study
COMPLETED
|
62
|
59
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Nitric Oxide First, Oxygen Last
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.
|
Oxygen First, Nitric Oxide Last
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Device Failure
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Inclusion/Exclusion Criteria
|
3
|
6
|
Baseline Characteristics
Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
Baseline characteristics by cohort
| Measure |
Nitric Oxide First, Oxygen Last
n=68 Participants
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.
|
Oxygen First, Nitric Oxide Last
n=68 Participants
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.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
68 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
5.9 years
STANDARD_DEVIATION 5.58 • n=5 Participants
|
5.9 years
STANDARD_DEVIATION 5.58 • n=7 Participants
|
5.9 years
STANDARD_DEVIATION 5.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
30 participants
n=5 Participants
|
27 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: on Day 1Population: All participants in the intent to treat analysis set who completed the study
A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)
Outcome measures
| Measure |
Nitric Oxide First, Oxygen Last
n=62 Participants
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.
|
Oxygen First, Nitric Oxide Last
n=59 Participants
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.
|
|---|---|---|
|
Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)
|
28 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: within 1 yearPopulation: All participants in the intent to treat analysis set who completed the study
Number of participants who received surgery for pulmonary or cardiac disease within 1 year after treatment.
Outcome measures
| Measure |
Nitric Oxide First, Oxygen Last
n=62 Participants
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.
|
Oxygen First, Nitric Oxide Last
n=59 Participants
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.
|
|---|---|---|
|
Number of Participants With Related Surgical Procedures Within 1 Year
|
44 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: on Day 1Population: All participants in the intent to treat analysis set who completed the study
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.
Outcome measures
| Measure |
Nitric Oxide First, Oxygen Last
n=62 Participants
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.
|
Oxygen First, Nitric Oxide Last
n=59 Participants
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.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: within 12 hoursPopulation: Participants in the intent to treat analysis set who completed the study
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.
Outcome measures
| Measure |
Nitric Oxide First, Oxygen Last
n=62 Participants
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.
|
Oxygen First, Nitric Oxide Last
n=59 Participants
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.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 3 yearsPopulation: Participants in the intent to treat population who completed the study
Number of participants who received surgery related to pulmonary or cardiac disease within 3 years
Outcome measures
| Measure |
Nitric Oxide First, Oxygen Last
n=62 Participants
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.
|
Oxygen First, Nitric Oxide Last
n=59 Participants
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.
|
|---|---|---|
|
Number of Participants With Related Surgical Procedures Within 3 Years
|
12 Participants
|
6 Participants
|
Adverse Events
Nitric Oxide First, Oxygen Last
Oxygen First, Nitric Oxide Last
Serious adverse events
| Measure |
Nitric Oxide First, Oxygen Last
n=62 participants at risk
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.
|
Oxygen First, Nitric Oxide Last
n=59 participants at risk
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.
|
|---|---|---|
|
Investigations
ST Segment Elevation
|
1.6%
1/62 • Number of events 1 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
0.00%
0/59 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
|
Cardiac disorders
Bradycardia
|
1.6%
1/62 • Number of events 1 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
0.00%
0/59 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
1.6%
1/62 • Number of events 1 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
0.00%
0/59 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
|
Cardiac disorders
Cardiac Arrest
|
1.6%
1/62 • Number of events 1 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
0.00%
0/59 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
|
Vascular disorders
Hypotension
|
1.6%
1/62 • Number of events 1 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
0.00%
0/59 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
|
Cardiac disorders
Low Cardiac Output Syndrome
|
1.6%
1/62 • Number of events 1 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
0.00%
0/59 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
|
Investigations
Decreased oxygen saturation
|
1.6%
1/62 • Number of events 1 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
0.00%
0/59 • within 3 years
No non-serious adverse events reached the 5% reporting threshold
|
Other adverse events
Adverse event data not reported
Additional Information
Medical Information Call Center
Mallinckrodt Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER