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

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

This study has been terminated.
Information provided by INO Therapeutics

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

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

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary Outcome Measure ^†

Methemoglobin level [ Time Frame: 24 and 72 hours after treatment start, then at 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measure ^†

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Adverse Event Occurence [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
Echocardiogram [ Time Frame: At 72 hours after treatment start, then at 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Condition ^†

Pulmonary Hypertension
Lung Disease
Sickle Cell Disease
Cardiac Transplant
Lung Transplant

Intervention ^†

Drug: Inhaled Nitric Oxide

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

Start Date ^†

April 2002

Completion Date

December 2005

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.

Gender

Both

Ages

5 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00041574

Organization ID

INOT-31

Secondary IDs ^††

Study Sponsor ^†

INO Therapeutics

Collaborators ^††

Investigators ^†

Principal Investigator:

Steven H Abman, MD

The Children's Hospital, Denver

Information Provided By

INO Therapeutics

Verification Date

February 2008

First Received Date ^†

July 10, 2002

Last Updated Date

February 28, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.