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.

Condition	Treatment or Intervention	Phase
Pulmonary Hypertension Lung Disease Sickle Cell Disease Cardiac transplant Lung transplant	Drug: INOmax (nitric oxide for inhalation)	Phase II

Further Study Details: 

Expected Total Enrollment:  40

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

Ages Eligible for Study:  up to  60 Years,  Genders Eligible for Study:  Both

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 Patients will not be withdrawn from the study if started on other medications for treatment of pulmonary hypertension.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

Robert Small      908-238-6605    Robert.Small@inotherapy.com

Colorado
      The Children's Hospital, Denver,  Colorado,  80262,  United States; Recruiting
      University of Colorado Hospital, Denver,  Colorado,  80262,  United States; Recruiting
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States; Recruiting

Study ID Numbers:  INOT-31
Record last reviewed:  February 2005
Last Updated:  February 7, 2005
Record first received:  July 10, 2002
ClinicalTrials.gov Identifier:  NCT00041574
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08