Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide
This study has been terminated.
(Closed for lack of enrollment)
Sponsor:
INO Therapeutics
Information provided by:
INO Therapeutics
ClinicalTrials.gov Identifier:
NCT00041574
First received: July 10, 2002
Last updated: January 9, 2009
Last verified: January 2009
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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 2 |
| 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
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 Colorado |
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 June 17, 2013