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

Sickle Cell Disease Clinical Trial

Official title: Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases

Status Terminated

Clinical Trial 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.

Clinical Trial 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:

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Cardiac Transplant
• Hypertension, Pulmonary
• Lung Disease
• Lung Diseases
• Lung Transplant
• Pulmonary Heart Disease
• Pulmonary Hypertension
• Sickle Cell Disease

• NCT number: NCT00041574
• Study type: Interventional
• Source: Mallinckrodt
• Status: Terminated
• Phase: Phase 2
• Start date: April 2002
• Completion date: December 2005