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

This study has been terminated.
Information provided by INO Therapeutics

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Descriptive Information Fields
Brief Title  Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide
Official Title  Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
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
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary Outcome Measure  Methemoglobin level [ Time Frame: 24 and 72 hours after treatment start, then at 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Vital Signs [ Time Frame: taken at 1, 2, 3, 4, 24, and 72 hours after treatment begins, then at 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
Pulse Oximetry [ Time Frame: taken at 1, 2, 3, 4, 24, and 72 hours after treatment start and then at 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Adverse Event Occurence [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
Echocardiogram [ Time Frame: At 72 hours after treatment start, then at 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Condition  Pulmonary Hypertension
Lung Disease
Sickle Cell Disease
Cardiac Transplant
Lung Transplant
Intervention  Drug: Inhaled Nitric Oxide
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment  7
Start Date  April 2002
Completion Date December 2005
Eligibility 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.

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.
Gender Both
Ages 5 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00041574
Organization ID INOT-31
Secondary IDs ††
Study Sponsor  INO Therapeutics
Collaborators ††
Investigators 
Principal Investigator:     Steven H Abman, MD     The Children's Hospital, Denver    
Information Provided By INO Therapeutics
Verification Date February 2008
First Received Date  July 10, 2002
Last Updated Date February 28, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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