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

Phase 2TerminatedNCT00041574

Mallinckrodt7 enrolled

Overview

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.

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: 1. Primary pulmonary hypertension (PPH) 2. Severe pulmonary hypertension due to congenital (anatomic) heart disease 3. Pulmonary hypertension or severe impairment of gas exchange in infants and children with chronic lung disease 4. Pulmonary hypertension or severe impairment of gas exchange due to severe chronic lung disease in adults 5. 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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Hypertension

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

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 Patients will not be withdrawn from the study if started on other medications for treatment of pulmonary hypertension.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.

Locations (3)

The Children's Hospital

Denver, Colorado, United States

University of Colorado Hospital

Denver, Colorado, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Methemoglobin level

Time frame: 24 and 72 hours after treatment start, then at 1, 3, 6, 9 and 12 months

Secondary Outcomes

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

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

Adverse Event Occurence

Time frame: Study Duration

Echocardiogram

Time frame: At 72 hours after treatment start, then at 3, 6, 9 and 12 months