Condition category
Injury, Occupational Diseases, Poisoning
Date applied
18/11/2011
Date assigned
31/01/2012
Last edited
31/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Acute respiratory distress syndrome (ARDS) is a disease in which the lungs are inflamed, wet and there is difficulty transmitting oxygen from the air that enters the lung as part of the breathing process into the blood. It has many causes including infectious and non-infectious. The objectives of this study were to add a gas called nitric oxide(NO) to the air that participants were breathing in order to raise the oxygen level in the blood in hopes of improving outcome in participants with ARDS.

Who can participate?
Patients aged 18 and over, regardless of sex, who have ARDS and are on a breathing machine (called a ventilator) in order to enable oxygen transfer into the blood.

What does the study involve?
The study compared inhaled nitric oxide (INO) added to the air the patient was breathing though the machine with a placebo nitrogen, a safe gas that makes up most of the air that we breathe and would have no effect on ARDS. All participants will receive the same treatment that they would have received for ARDS, even if they had not participated in the study. If patients were randomly allocated to the group receiving inhaled nitric oxide, this would have been the additional therapy.

What are the possible benefits and risks of participating?
By participating it is possible that the subject will have improved oxygenation and that this may lead to improved outcome. There are no anticipated potential side effects of the treatment when delivered at the doses that will be used in this study.

Where is the study run from?
There were 35 centers taking part in this trial and the lead center is St. Johns Mercy Hospital St. Louis, Missouri.

When is study starting and how long is it expected to run for?
The start date of the study was 1996 and the duration of the study was approximately 3 years. Recruitment of participants was until late summer/fall 1999.

Who is funding the study?
The study was funded by INO Therapeutics (Now called IKARIA). They paid the costs associated with the trial.

Who is the main contact?
Phil Dellinger
dellinger-phil@cooperhealth.edu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Dellinger

ORCID ID

Contact details

Cooper University Hospital
One Cooper Plaza
Camden
New Jersey
19102
United States of America
+1 856 342 2632
dellinger-phil@cooperhealth.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

INOT06

Study information

Scientific title

Low dose inhaled nitric oxide in patients with acute lung injury: a randomized controlled trial

Acronym

Study hypothesis

To evaluate the clinical efficacy of low-dose (5-ppm) inhaled nitric oxide in patients with acute lung injury.

Ethics approval

Human Subjects Committee (USA), 15 February 1996

Study design

Multicenter randomized blinded placebo-controlled

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute lung injury

Intervention

Inhaled nitric oxide (5ppm) or placebo (nitrogen gas) is delivered with mechanical ventilator breaths until the patient is extubated or for a total of 28 days.

Intervention type

Drug

Phase

Not Applicable

Drug names

Nitric oxide

Primary outcome measures

Days alive and off mechanical ventilation

Secondary outcome measures

Pulmonary function including spirometry, lung volumes and diffusion of carbon monoxide evaluated at 6 months

Overall trial start date

27/03/1996

Overall trial end date

08/09/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. Mechanically ventilated patients with acute lung injury
2. Ratio of partial pressure of arterial oxygen (O2) to the fraction of inspired partial pressure of oxygen in arterial blood/fraction of inspired oxygen (Pa02/FiO2) ratio of 250 or less

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

385

Participant exclusion criteria

Sepsis as the cause of the acute lung injury

Recruitment start date

27/03/1996

Recruitment end date

08/09/1999

Locations

Countries of recruitment

United States of America

Trial participating centre

Cooper University Hospital
Camden, New Jersey
19102
United States of America

Sponsor information

Organisation

Ohmeda/INO Therapeutics Inc (USA)

Sponsor details

c/o Ikaria Inc
Perryville III Corporate Park
53 Frontage Road
Hampton
New Jersey
08827
United States of America

Sponsor type

Industry

Website

http://www.ikaria.com

Funders

Funder type

Industry

Funder name

Ohmeda PPD/INO Therapeutics Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15069048

Publication citations

  1. Results

    Taylor RW, Zimmerman JL, Dellinger RP, Straube RC, Criner GJ, Davis K, Kelly KM, Smith TC, Small RJ, , Low-dose inhaled nitric oxide in patients with acute lung injury: a randomized controlled trial., JAMA, 2004, 291, 13, 1603-1609, doi: 10.1001/jama.291.13.1603.

Additional files

Editorial Notes