search
Back to results

Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing

Primary Purpose

Idiopathic Pulmonary Arterial Hypertension, Cardiomyopathy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nitric Oxide for inhalation
Oxygen
Nitric Oxide plus Oxygen
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Idiopathic Pulmonary Arterial Hypertension focused on measuring 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

Eligibility Criteria

4 Weeks - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. Scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity by acute pulmonary vasodilation testing.
  3. Male or female, ages 4 weeks to 18 years, inclusive
  4. Signed informed consent/assent

Exclusion Criteria:

  1. Focal pulmonary infiltrates on chest radiograph.
  2. Diagnosed with severe obstructive or restrictive pulmonary disease that is significantly contributing to the patient's pulmonary hypertension.
  3. 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
  4. Pregnant [urine human chorionic gonadotropin positive (HCG +)]
  5. Baseline Pulmonary capillary wedge pressure (PCWP) > 20 mmHg

Sites / Locations

  • Lucile Salter Packard Children's Hospital at Stanford
  • The Children's Hospital
  • Children's Hospital Boston
  • St. Louis Children's Hospital
  • New York Presbyterian Hospital
  • Cincinnati Children's Hospital
  • Columbus Children's Hospital
  • The Medical University of South Carolina
  • CHU Timone - Département de cardiologie
  • Hôpital d'Enfants
  • Hôpital NECKER - Enfants Malades
  • Beatrix Children's Hospital / University Hospital Groningen
  • Hospital Sant Joan de Déu de Barcelona
  • Unidad de Cardiologia Infantil - Hospital Vall d'Hebrón
  • Hospital Gregorio Maranon
  • Instituto Pediátrico del Corazón - Hospital Materno Infatil Doce de Octubre
  • Royal Brompton Hospital
  • Southampton University Hospitals Trust - Wessex Cardiothoracic Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nitric Oxide First, Oxygen Last

Oxygen First, Nitric Oxide Last

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)
A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)

Secondary Outcome Measures

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.
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.
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.
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

Full Information

First Posted
February 20, 2008
Last Updated
December 6, 2019
Sponsor
Mallinckrodt
search

1. Study Identification

Unique Protocol Identification Number
NCT00626028
Brief Title
Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2004 (Actual)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Arterial Hypertension, Cardiomyopathy
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitric Oxide First, Oxygen Last
Arm Type
Experimental
Arm Description
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.
Arm Title
Oxygen First, Nitric Oxide Last
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nitric Oxide for inhalation
Other Intervention Name(s)
INOmax®
Intervention Description
Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Intervention Type
Drug
Intervention Name(s)
Nitric Oxide plus Oxygen
Other Intervention Name(s)
Inhaled Nitric Oxide, Oxygen
Intervention Description
Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system
Primary Outcome Measure Information:
Title
Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity)
Description
A composite of hemodynamic measurements were used to identify reversible pulmonary hypertension (vasoreactivity)
Time Frame
on Day 1
Secondary Outcome Measure Information:
Title
Number of Participants With Related Surgical Procedures Within 1 Year
Description
Number of participants who received surgery for pulmonary or cardiac disease within 1 year after treatment.
Time Frame
within 1 year
Title
Number of Participants With Adverse Events (AEs)
Description
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
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
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
Title
Number of Participants With Related Surgical Procedures Within 3 Years
Description
Number of participants who received surgery related to pulmonary or cardiac disease within 3 years
Time Frame
within 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader, MD
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Lucile Salter Packard Children's Hospital at Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
The Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Columbus Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
CHU Timone - Département de cardiologie
City
Marseille
Country
France
Facility Name
Hôpital d'Enfants
City
Nancy
Country
France
Facility Name
Hôpital NECKER - Enfants Malades
City
Paris
Country
France
Facility Name
Beatrix Children's Hospital / University Hospital Groningen
City
Groningen
Country
Netherlands
Facility Name
Hospital Sant Joan de Déu de Barcelona
City
Barcelona
Country
Spain
Facility Name
Unidad de Cardiologia Infantil - Hospital Vall d'Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital Gregorio Maranon
City
Madrid
Country
Spain
Facility Name
Instituto Pediátrico del Corazón - Hospital Materno Infatil Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom
Facility Name
Southampton University Hospitals Trust - Wessex Cardiothoracic Centre
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20405117
Citation
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.
Results Reference
derived

Learn more about this trial

Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing

We'll reach out to this number within 24 hrs