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

December 6, 2019 updated by: Mallinckrodt

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • CHU Timone - Département de cardiologie
      • Nancy, France
        • Hôpital d'Enfants
      • Paris, France
        • Hopital Necker - Enfants Malades
  • Netherlands
      • Groningen, Netherlands
        • Beatrix Children's Hospital / University Hospital Groningen
  • Spain
      • Barcelona, Spain
        • Hospital Sant Joan de Déu de Barcelona
      • Barcelona, Spain
        • Unidad de Cardiologia Infantil - Hospital Vall d'Hebrón
      • Madrid, Spain
        • Hospital Gregorio Maranon
      • Madrid, Spain
        • Instituto Pediátrico del Corazón - Hospital Materno Infatil Doce de Octubre
  • United Kingdom
      • London, United Kingdom
        • Royal Brompton Hospital
      • Southampton, United Kingdom
        • Southampton University Hospitals Trust - Wessex Cardiothoracic Centre
  • United States
    • California
      • Stanford, California, United States, 94304
        • Lucile Salter Packard Children's Hospital at Stanford
    • Colorado
      • Denver, Colorado, United States, 80218
        • The Children's Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
    • New York
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital
      • Columbus, Ohio, United States, 43205
        • Columbus Children's Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • The Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Nitric Oxide for inhalation
Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Other Names:
  • INOmax®
Drug: Oxygen
100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Drug: Nitric Oxide plus Oxygen
Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system
Other Names:
  • Inhaled Nitric Oxide, Oxygen
Experimental: 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.
Drug: Nitric Oxide for inhalation
Nitric Oxide (NO) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Other Names:
  • INOmax®
Drug: Oxygen
100% oxygen (O2) for inhalation, given at 80ppm over 10 minutes using an INOvent® delivery system
Drug: Nitric Oxide plus Oxygen
Nitric Oxide (NO) for inhalation plus oxygen, given at 80ppm over 10 minutes using an INOvent® delivery system
Other Names:
  • Inhaled Nitric Oxide, Oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
on Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Related Surgical Procedures Within 1 Year
Time Frame: within 1 year
Number of participants who received surgery for pulmonary or cardiac disease within 1 year after treatment.
within 1 year
Number of Participants With Adverse Events (AEs)
Time Frame: on Day 1
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.
on Day 1
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: within 12 hours
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.
within 12 hours
Number of Participants With Related Surgical Procedures Within 3 Years
Time Frame: within 3 years
Number of participants who received surgery related to pulmonary or cardiac disease within 3 years
within 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mallinckrodt

Investigators

  • Study Director: Global Clinical Leader, MD, Mallinckrodt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2004

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Actual)

December 20, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INOT22
  • 2004-000625-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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