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

This study has been completed.
Sponsor:
Information provided by:
INO Therapeutics
ClinicalTrials.gov Identifier:
NCT00626028
First received: February 20, 2008
Last updated: October 18, 2010
Last verified: October 2010
Results First Received: September 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Idiopathic Pulmonary Arterial Hypertension
Congenital Heart Disease With Pulmonary Hypertension
Cardiomyopathy
Interventions: Drug: Nitric Oxide for inhalation
Drug: Oxygen
Drug: Nitric Oxide plus Oxygen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Children scheduled for clinically indicated right heart catheterization were screened for enrollment. Participants were enrolled at 16 centers in the United States, United Kingdom, France, Spain and Netherlands.

Study duration was 2 years (primary) with 1 and 3 year follow-ups.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One hundred thirty six participants were enrolled (intent-to-treat population). One hundred twenty-one participants completed the study. Participants served as their own controls and received all 3 treatments.

Reporting Groups
  Description
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
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

Participant Flow for 4 periods

Period 1:   Treatment 1 NO First, O2 Last
    Nitric Oxide First, Oxygen Last     Oxygen First, Nitric Oxide Last  
STARTED     68     68  
COMPLETED     62     59  
NOT COMPLETED     6     9  
Adverse Event                 1                 1  
Device Failure                 0                 1  
Physician Decision                 2                 1  
Inclusion/Exclusion Criteria                 3                 6  

Period 2:   Treatment 2 10 Minute Dose NO Plus O2
    Nitric Oxide First, Oxygen Last     Oxygen First, Nitric Oxide Last  
STARTED     62     59  
COMPLETED     62     59  
NOT COMPLETED     0     0  

Period 3:   Washout Period of 10 Minutes
    Nitric Oxide First, Oxygen Last     Oxygen First, Nitric Oxide Last  
STARTED     62     59  
COMPLETED     62     59  
NOT COMPLETED     0     0  

Period 4:   Treatment 3 10 Minute Dose NO or O2
    Nitric Oxide First, Oxygen Last     Oxygen First, Nitric Oxide Last  
STARTED     62     59  
COMPLETED     62     59  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
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
Total Total of all reporting groups

Baseline Measures
    Nitric Oxide First, Oxygen Last     Oxygen First, Nitric Oxide Last     Total  
Number of Participants  
[units: participants]
  68     68     136  
Age [1]
[units: participants]
     
<=18 years     68     68     136  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age [1]
[units: years]
Mean ± Standard Deviation
  5.9  ± 5.58     5.9  ± 5.58     5.9  ± 5.58  
Gender [1]
[units: participants]
     
Female     34     34     68  
Male     34     34     68  
Region of Enrollment  
[units: participants]
     
France     30     27     57  
United States     15     17     32  
Spain     12     12     24  
Netherlands     5     6     11  
United Kingdom     6     6     12  
[1] Data for baseline measures are for the overall intent-to treat population - total 136 participants



  Outcome Measures
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1.  Primary:   Reversible Pulmonary Hypertension (Vasoreactivity)as Defined by Hemodynamic Measurements   [ Time Frame: 1 year ]

2.  Secondary:   Surgical Procedures at 1 Year   [ Time Frame: 1 year after treatment ]

3.  Secondary:   Surgical Procedures at 3 Years   [ Time Frame: 3 years after treatment ]

4.  Secondary:   Adverse Events   [ Time Frame: treatment 1 through treatment 3 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Serious Adverse Events   [ Time Frame: 12 hours after discontinuation of gas or dischange (whichever comes first) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Although the first and last treatments were randomly assigned, the second treatment was always the iNO/O2 combination. Without randomization of all 3 treatments, we cannot exclude an interaction of time with treatment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: James Baldassarre, MD
Organization: Ikaria
phone: 908-238-6363
e-mail: james.baldassarre@ikaria.com


No publications provided by INO Therapeutics

Publications automatically indexed to this study:

Responsible Party: James Baldassarre, MD, INO Therapeutics
ClinicalTrials.gov Identifier: NCT00626028     History of Changes
Other Study ID Numbers: INOT 22
Study First Received: February 20, 2008
Results First Received: September 21, 2009
Last Updated: October 18, 2010
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Agencia Española del Medicamento y Productos Sanitarios
The Netherlands: Rijksinstituut voor Volksgezondheid en Milieu