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Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide
This study has been terminated.
( Closed for lack of enrollment )
Study NCT00041574   Information provided by INO Therapeutics
First Received: July 10, 2002   Last Updated: January 9, 2009   History of Changes

July 10, 2002
January 9, 2009
April 2002
December 2005   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00041574 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide
Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases

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.

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
Phase II
Interventional
Allocation:  Non-Randomized
Control:  Uncontrolled
Endpoint Classification:  Safety Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Treatment
  • Pulmonary Hypertension
  • Lung Disease
  • Sickle Cell Disease
  • Cardiac Transplant
  • Lung Transplant
Drug: Inhaled Nitric Oxide
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).
Other Name: INOmax®
1: Experimental
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: Drug: Inhaled Nitric Oxide
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
7
December 2005
December 2005   (final data collection date for primary outcome measure)

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.
Both
5 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00041574
Robert Small, INO Therapeutics
INOT-31
INO Therapeutics
 
Principal Investigator: Steven H Abman, MD The Children's Hospital, Denver
INO Therapeutics
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP