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

Sponsored by:	INO Therapeutics
Information provided by:	INO Therapeutics
ClinicalTrials.gov Identifier:	NCT00041574

Purpose

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	Intervention	Phase
Pulmonary Hypertension Lung Disease Sickle Cell Disease Cardiac Transplant Lung Transplant	Drug: Inhaled Nitric Oxide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension Sickle Cell Anemia

Drug Information available for: Nitric oxide

U.S. FDA Resources

Further study details as provided by INO Therapeutics:

Primary Outcome Measures:

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 Measures:

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 ]

Enrollment:	7
Study Start Date:	April 2002
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).	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).

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:

Primary pulmonary hypertension (PPH)
Severe pulmonary hypertension due to congenital (anatomic) heart disease
Pulmonary hypertension or severe impairment of gas exchange in infants and children with chronic lung disease
Pulmonary hypertension or severe impairment of gas exchange due to severe chronic lung disease in adults
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

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041574

Locations

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

Sponsors and Collaborators

INO Therapeutics

Investigators

Principal Investigator:

Steven H Abman, MD

The Children's Hospital, Denver

More Information

No publications provided

Responsible Party:	INO Therapeutics ( Robert Small )
Study ID Numbers:	INOT-31
Study First Received:	July 10, 2002
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00041574 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Heart Diseases
Hematologic Diseases
Anemia
Vascular Diseases
Anti-Asthmatic Agents
Anemia, Hemolytic
Cardiovascular Agents
Nitric Oxide
Anemia, Hemolytic, Congenital

Respiratory Tract Diseases
Genetic Diseases, Inborn
Hypertension, Pulmonary
Lung Diseases
Hemoglobinopathies
Sickle Cell Anemia
Pulmonary Heart Disease
Peripheral Nervous System Agents
Hemoglobinopathy
Bronchodilator Agents
Anemia, Sickle Cell
Hypertension

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Respiratory Tract Diseases
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Cardiovascular Diseases
Anemia, Sickle Cell
Heart Diseases
Hematologic Diseases
Vascular Diseases

Anemia
Anemia, Hemolytic
Anti-Asthmatic Agents
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Nitric Oxide
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hypertension, Pulmonary
Autonomic Agents
Hemoglobinopathies
Lung Diseases
Pulmonary Heart Disease
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009