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

Sponsor:	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:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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
Experimental: 1 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). Other Name: INOmax®

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

Children's Hospital Colorad

More Information

No publications provided

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

Additional relevant MeSH terms:

Anemia, Sickle Cell
Hypertension
Hypertension, Pulmonary
Lung Diseases
Pulmonary Heart Disease
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Heart Diseases

Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents

ClinicalTrials.gov processed this record on February 12, 2012