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
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
-
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.