|
Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases Clinical research trials and Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases. Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases clinical trial. Test subjects typically obtain the finest healthcare available for their Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases  Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
For Condition: Pulmonary Hypertension,Lung Disease,Lung transplant,Sickle Cell Disease,Cardiac transplant
Status: Recruiting
Sponsor(s): INO Therapeutics ,
Synopsis: 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.
Details: 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
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: /60 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: 1) - 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. 2)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. 3)Ability to establish a clinical investigator and a drug shipment site in the local area.
Total Enrollment: 40
Location and Contact Information:
The Children's Hospital *Recruiting*
Denver, Colorado, 80262
United States
Recruiting Steven Abman
Rhode Island Hospital *Recruiting*
Providence, Rhode Island, 02903
United States
Recruiting James Klinger
University of Colorado Hospital *Recruiting*
Denver, Colorado, 80262
United States
Recruiting David Badesch
Additional Information:
Study ID Numbers: INOT-31;
Study Start Date: April 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041574
Other Sickle Cell Disease Studies:
1. Segmental Bronchoalveolar Lavage
2. Biomarkers of Benzene Exposure in Inner City Residents
3. Role of Genetic Factors in the Development of Lung Disease
4. Cardiovascular Vulnerability to Particulate Exposure
5. Study of the Disease Process of Lymphangioleiomyomatosis
Related Studies:
Other Sickle Cell Disease Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
|
|
|
|
|
|
|
|
