NCT00041574

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2002

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2002

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

3.7 years

First QC Date

July 10, 2002

Last Update Submit

September 8, 2016

Conditions

Pulmonary HypertensionLung DiseaseSickle Cell DiseaseCardiac TransplantLung Transplant

Outcome Measures

Primary Outcomes (1)

  • Methemoglobin level

    24 and 72 hours after treatment start, then at 1, 3, 6, 9 and 12 months

Secondary Outcomes (4)

  • 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

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Inhaled Nitric OxideDRUG

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).

Also known as: INOmax®
1

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Children's Hospital

Denver, Colorado, 80262, United States

Location

University of Colorado Hospital

Denver, Colorado, 80262, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Hypertension, PulmonaryLung DiseasesAnemia, Sickle Cell

Interventions

Endothelium-Dependent Relaxing Factors

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Vasodilator AgentsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Steven H Abman, MD

    Children's Hospital Colorado

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 10, 2002

First Posted

July 11, 2002

Study Start

April 1, 2002

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

September 9, 2016

Record last verified: 2016-09

Locations

US(3)