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

Sickle Cell Disease Clinical Trial

Official title:

Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00041574
• Other study ID #: INOT-31
• Status: Terminated
• Phase: Phase 2
• First received: July 10, 2002
• Last updated: September 8, 2016
• Start date: April 2002
• Est. completion date: December 2005

Study information

• Verified date: September 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Cardiac Transplant
• Hypertension, Pulmonary
• Lung Disease
• Lung Diseases
• Lung Transplant
• Pulmonary Heart Disease
• Pulmonary Hypertension
• Sickle Cell Disease

Intervention

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).

Locations

Country	Name	City	State
United States	The Children's Hospital	Denver	Colorado
United States	University of Colorado Hospital	Denver	Colorado
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methemoglobin level		24 and 72 hours after treatment start, then at 1, 3, 6, 9 and 12 months	Yes
Secondary	Vital Signs		taken at 1, 2, 3, 4, 24, and 72 hours after treatment begins, then at 1, 3, 6, 9 and 12 months	Yes
Secondary	Pulse Oximetry		taken at 1, 2, 3, 4, 24, and 72 hours after treatment start and then at 1, 3, 6, 9 and 12 months	No
Secondary	Adverse Event Occurence		Study Duration	Yes
Secondary	Echocardiogram		At 72 hours after treatment start, then at 3, 6, 9 and 12 months	No