Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide
Stopped early · Phase 2
Conditions studied: Pulmonary Hypertension, Lung Disease, Sickle Cell Disease, Cardiac Transplant, Lung Transplant
In brief
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.
Key facts
- Study ID
- NCT00041574
- Run by
- Mallinckrodt
- People needed
- 7
- Starts
- 2002-04-01
- Expected to finish
- 2005-12-01
- Last updated by the study team
- 2016-09-09
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 Patients will not be withdrawn from the study if started on other medications for treatment of pulmonary hypertension.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.
You may not qualify if…
- 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.
Where it is running
- The Children's Hospital — Denver, Colorado, United States
- University of Colorado Hospital — Denver, Colorado, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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