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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00626028
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : September 16, 2010
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Arterial Hypertension Cardiomyopathy Drug: Nitric Oxide for inhalation Drug: Oxygen Drug: Nitric Oxide plus Oxygen Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : September 2004
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010


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 Name: 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 Name: 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 Name: 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 Name: Inhaled Nitric Oxide, Oxygen




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626028


Locations
Show Show 18 study locations
Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Global Clinical Leader, MD Mallinckrodt
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00626028    
Other Study ID Numbers: INOT22
2004-000625-30 ( EudraCT Number )
First Posted: February 29, 2008    Key Record Dates
Results First Posted: September 16, 2010
Last Update Posted: December 20, 2019
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mallinckrodt:
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
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Cardiomyopathies
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents