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Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide

Primary Purpose

Pulmonary Hypertension, Lung Disease, Sickle Cell Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Inhaled Nitric Oxide
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Patients with pulmonary arterial hypertension (PAH) as defines by a mean pulmonary artery pressure (PAP) of 25 mmHg or greater by cardiac catheterization within the previous 12 months AND/OR Patients with chronic lung disease with severe impairment of gas exchange unresponsive to conventional medical management. If patient is receiving prostacyclin infusion treatment it must have been started at least one month prior to starting INO therapy. Patients will not be withdrawn from the study if started on other medications for treatment of pulmonary hypertension. Ability to establish a clinical investigator and a drug shipment site in the local area. Exclusion Criteria: The Principal Investigator has determined that the patient and/or caregiver is/are unable to manage safe administration of home nitric oxide therapy and maintain appropriate drug accountability and storage. Women who are pregnant or nursing.

Sites / Locations

  • The Children's Hospital
  • University of Colorado Hospital
  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Inhaled Nitric Oxide will be delivered through the INOpulse® at a Low Dose Range (3mL to 10mL; in 1mL increments) and Ultra Low Dose Ranges (0.5mL to 4mL; 0.5mL, then 1 to 4mL in 1mL increments).

Outcomes

Primary Outcome Measures

Methemoglobin level

Secondary Outcome Measures

Vital Signs
Pulse Oximetry
Adverse Event Occurence
Echocardiogram

Full Information

First Posted
July 10, 2002
Last Updated
September 8, 2016
Sponsor
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT00041574
Brief Title
Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide
Official Title
Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Closed for lack of enrollment
Study Start Date
April 2002 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mallinckrodt

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient needs, patients with a variety of underlying diseases will be included. Safety of chronic therapy will be monitored by serial measurements of methemoglobin, platelet function assay and reported adverse events.
Detailed Description
This study will help develop a comprehensive home care program using INOmax delivery systems. This study will enroll a limited number of patients (5-7) from several disease categories in order to develop the experience with testing acute and chronic responsiveness to INO therapy. The following groups will be tested: Primary pulmonary hypertension (PPH) Severe pulmonary hypertension due to congenital (anatomic) heart disease Pulmonary hypertension or severe impairment of gas exchange in infants and children with chronic lung disease Pulmonary hypertension or severe impairment of gas exchange due to severe chronic lung disease in adults Pulmonary hypertension or severe impairment of gas exchange in hematologic and transplant disorders - young children and adults with sickle cell disease, chronic lung disease after bone marrow transplant, cardiac transplant, or lung transplant

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Lung Disease, Sickle Cell Disease, Cardiac Transplant, Lung Transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Inhaled Nitric Oxide will be delivered through the INOpulse® at a Low Dose Range (3mL to 10mL; in 1mL increments) and Ultra Low Dose Ranges (0.5mL to 4mL; 0.5mL, then 1 to 4mL in 1mL increments).
Intervention Type
Drug
Intervention Name(s)
Inhaled Nitric Oxide
Other Intervention Name(s)
INOmax®
Intervention Description
Inhaled Nitric Oxide will be delivered through the INOpulse® at a Low Dose Range (3mL to 10mL; in 1mL increments) and Ultra Low Dose Ranges (0.5mL to 4mL; 0.5mL, then 1 to 4mL in 1mL increments).
Primary Outcome Measure Information:
Title
Methemoglobin level
Time Frame
24 and 72 hours after treatment start, then at 1, 3, 6, 9 and 12 months
Secondary Outcome Measure Information:
Title
Vital Signs
Time Frame
taken at 1, 2, 3, 4, 24, and 72 hours after treatment begins, then at 1, 3, 6, 9 and 12 months
Title
Pulse Oximetry
Time Frame
taken at 1, 2, 3, 4, 24, and 72 hours after treatment start and then at 1, 3, 6, 9 and 12 months
Title
Adverse Event Occurence
Time Frame
Study Duration
Title
Echocardiogram
Time Frame
At 72 hours after treatment start, then at 3, 6, 9 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients with pulmonary arterial hypertension (PAH) as defines by a mean pulmonary artery pressure (PAP) of 25 mmHg or greater by cardiac catheterization within the previous 12 months AND/OR Patients with chronic lung disease with severe impairment of gas exchange unresponsive to conventional medical management. If patient is receiving prostacyclin infusion treatment it must have been started at least one month prior to starting INO therapy. Patients will not be withdrawn from the study if started on other medications for treatment of pulmonary hypertension. Ability to establish a clinical investigator and a drug shipment site in the local area. Exclusion Criteria: The Principal Investigator has determined that the patient and/or caregiver is/are unable to manage safe administration of home nitric oxide therapy and maintain appropriate drug accountability and storage. Women who are pregnant or nursing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven H Abman, MD
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
University of Colorado Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide

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