Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
Overview
- Phase
- Phase 2
- Intervention
- Inhaled Nitric Oxide
- Conditions
- Pulmonary Hypertension
- Sponsor
- Mallinckrodt
- Enrollment
- 7
- Locations
- 3
- Primary Endpoint
- Methemoglobin level
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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: 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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Arms & Interventions
1
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: Inhaled Nitric Oxide
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(taken at 1, 2, 3, 4, 24, and 72 hours after treatment begins, then at 1, 3, 6, 9 and 12 months)
- Adverse Event Occurence(Study Duration)
- Echocardiogram(At 72 hours after treatment start, then at 3, 6, 9 and 12 months)
- Pulse Oximetry(taken at 1, 2, 3, 4, 24, and 72 hours after treatment start and then at 1, 3, 6, 9 and 12 months)