NCT00041574

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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: 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

Conditions

• Pulmonary Hypertension
• Lung Disease
• Sickle Cell Disease
• Cardiac Transplant
• Lung Transplant

Interventions

Type	Name	Description
DRUG	Inhaled Nitric Oxide	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).

Timeline

• Start date: 2002-04-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2002-07-11
• Last updated: 2016-09-09

Locations

3 sites across 1 country: United States