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

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

Sponsoren

Hauptsponsor: Mallinckrodt

Quelle Mallinckrodt
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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

Gesamtstatus Terminated
Anfangsdatum April 2002
Fertigstellungstermin December 2005
Primäres Abschlussdatum December 2005
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Methemoglobin level 24 and 72 hours after treatment start, then at 1, 3, 6, 9 and 12 months
Sekundäres Ergebnis
Messen Zeitfenster
Vital Signs taken at 1, 2, 3, 4, 24, and 72 hours after treatment begins, then at 1, 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
Adverse Event Occurence Study Duration
Echocardiogram At 72 hours after treatment start, then at 3, 6, 9 and 12 months
Einschreibung 7
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Inhaled Nitric Oxide

Beschreibung: 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).

Armgruppenetikett: 1

Anderer Name: INOmax®

Teilnahmeberechtigung

Kriterien:

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.

Geschlecht: All

Mindestalter: 5 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Steven H Abman, MD Principal Investigator Children's Hospital Colorado
Ort
Einrichtung:
The Children's Hospital | Denver, Colorado, 80262, United States
University of Colorado Hospital | Denver, Colorado, 80262, United States
Rhode Island Hospital | Providence, Rhode Island, 02903, United States
Standort Länder

United States

Überprüfungsdatum

September 2016

Verantwortliche Partei

Nenne den Titel: Robert Small

Organisation: INO Therapeutics

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 1
Armgruppe

Etikette: 1

Art: Experimental

Beschreibung: 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).

Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov