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

History of Changes

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.

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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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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

Adverse Events [ Time Frame: treatment 1 through treatment 3 ]

Results not yet posted. Anticipated Posting 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 posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

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.

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:

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. Epub 2010 Apr 20.

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

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