Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
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
2 other identifiers
interventional
136
5 countries
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2004
Longer than P75 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 20, 2008
CompletedFirst Posted
Study publicly available on registry
February 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
September 16, 2010
CompletedDecember 20, 2019
September 1, 2016
5.4 years
February 20, 2008
September 21, 2009
December 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)
A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)
on Day 1
Secondary Outcomes (4)
Number of Participants With Related Surgical Procedures Within 1 Year
within 1 year
Number of Participants With Adverse Events (AEs)
on Day 1
Number of Participants With Serious Adverse Events (SAEs)
within 12 hours
Number of Participants With Related Surgical Procedures Within 3 Years
within 3 years
Study Arms (2)
Nitric Oxide First, Oxygen Last
EXPERIMENTAL10 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
EXPERIMENTAL10 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.
Interventions
Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mallinckrodtlead
Study Sites (18)
Lucile Salter Packard Children's Hospital at Stanford
Stanford, California, 94304, United States
The Children's Hospital
Denver, Colorado, 80218, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
New York Presbyterian Hospital
New York, New York, 10032, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Columbus Children's Hospital
Columbus, Ohio, 43205, United States
The Medical University of South Carolina
Charleston, South Carolina, 29425, United States
CHU Timone - Département de cardiologie
Marseille, France
Hôpital d'Enfants
Nancy, France
Hôpital NECKER - Enfants Malades
Paris, France
Beatrix Children's Hospital / University Hospital Groningen
Groningen, Netherlands
Hospital Sant Joan de Déu de Barcelona
Barcelona, Spain
Unidad de Cardiologia Infantil - Hospital Vall d'Hebrón
Barcelona, Spain
Hospital Gregorio Maranon
Madrid, Spain
Instituto Pediátrico del Corazón - Hospital Materno Infatil Doce de Octubre
Madrid, Spain
Royal Brompton Hospital
London, United Kingdom
Southampton University Hospitals Trust - Wessex Cardiothoracic Centre
Southampton, United Kingdom
Related Publications (1)
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.
PMID: 20405117DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Although the first and last treatments were randomly assigned, the second treatment was always the same. Therefore, a time/treatment interaction cannot be ruled out.
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Global Clinical Leader, MD
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2008
First Posted
February 29, 2008
Study Start
September 1, 2004
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
December 20, 2019
Results First Posted
September 16, 2010
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share