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

Phase 2

Terminated

• Conditions: Lung Disease; Cardiac Transplant; Sickle Cell Disease; Lung Transplant; Pulmonary Hypertension
• Interventions: Drug: Inhaled Nitric Oxide

• Registration Number: NCT00041574
• Lead Sponsor: Mallinckrodt

Brief 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.

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:

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

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2002-07-10
• Study First Submitted QC: 2002-07-10
• Study First Posted: 2002-07-11
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	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).

Primary Outcome Measures

Name	Time	Method
Methemoglobin level	24 and 72 hours after treatment start, then at 1, 3, 6, 9 and 12 months

Secondary Outcome Measures

Name	Time	Method
Vital Signs	taken at 1, 2, 3, 4, 24, and 72 hours after treatment begins, then at 1, 3, 6, 9 and 12 months
Adverse Event Occurence	Study Duration
Echocardiogram	At 72 hours after treatment start, then at 3, 6, 9 and 12 months
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

Trial Locations

Locations (3)

The Children's Hospital; 🇺🇸 Denver, Colorado, United States

University of Colorado Hospital; 🇺🇸 Denver, Colorado, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States