Study Stopped
Stopped for futility by DSMB
Drug Study of Albuterol to Treat Acute Lung Injury
ALTA
Prospective, Randomized, Multicenter Trial of Aerosolized Albuterol Versus Placebo in Acute Lung Injury
3 other identifiers
interventional
282
1 country
40
Brief Summary
Acute Respiratory Distress Syndrome (ARDS) and a lesser condition that occurs prior to ARDS, Acute Lung Injury (ALI), are medical conditions that occur when there is severe inflammation and increased fluids (edema) in both lungs, making it hard for the lungs to function properly. Patients with these conditions require treatment that includes the use of a breathing machine (ventilator). The purpose of this study is to find out whether giving albuterol (a drug commonly used in asthmatics) or not giving albuterol to patients with ALI or ARDS makes a difference in how long it takes for a patient to be able to breath without the ventilator.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2007
Shorter than P25 for phase_2
40 active sites
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
First Submitted
Initial submission to the registry
January 29, 2007
CompletedFirst Posted
Study publicly available on registry
February 14, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
July 15, 2013
CompletedFebruary 10, 2017
December 1, 2016
1.1 years
January 29, 2007
December 4, 2012
December 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Ventilator Free Days (VFD)
Ventilator-free days (VFDs) is defined as the number of days from randomization to Day 28 after achieving unassisted breathing for patients who maintained unassisted breathing for at least two consecutive calendar days. If a patient achieved unassisted breathing, subsequently required additional assisted breathing, and once again achieved unassisted breathing, we counted only the VFDs after beginning the final period of unassisted breathing. Patients who died before Day 28 were assigned zero VFDs.
Determined 28 days after a subject entered the study
Secondary Outcomes (9)
Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60
Determined 60 days after a subject entered the study
Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90
Determined 90 days after a subject entered the study
Number of ICU-free Days at 28 Days After Randomization
Determined 28 days after a subject entered the study
Number of Organ Failure-free Days at Day 28 Following Randomization
Daily from baseline to study day 28
Ventilator Free Days to Day 28 in the Subset of Participants With ARDS
Determined 28 days after a subject entered the study
- +4 more secondary outcomes
Study Arms (2)
Albuterol Sulfate
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Albuterol sulfate, USP, solution for inhalation will be diluted as follows: * The full dose of 5.0 mg will be diluted into 2.0 ml of sterile normal saline solution. * The reduced dose of 2.5 mg will be diluted into 2.5 ml of sterile normal saline solution. A high-efficiency small volume jet nebulizer (SVN) powered at a flow of 8 liters/minute from a 50 psi wall oxygen flow meter will be used for continuous nebulization. The study drug will be given every 4 hours (plus or minus one hour) for ten days following randomization or until 24 hours after extubation, whichever occurs first.
The mini-BAL procedure involves blind specimen sampling from distal airspaces. Specimens are obtained with the Combicath (Plastimed) catheter. The procedure will be done on study days 0 and 3
Placebo aerosol will consist of 3.0 ml of identical appearing sterile 0.9 % sodium chloride without preservative. A high-efficiency small volume jet nebulizer (SVN) powered at a flow of 8 liters/minute from a 50 psi wall oxygen flow meter will be used for continuous nebulization (e.g.: throughout the inspiratory and expiratory cycle). The study drug will be given every 4 hours (plus or minus one hour) for ten days following randomization or until 24 hours after extubation, whichever occurs first.
Eligibility Criteria
You may qualify if:
- Must meet the following three criteria within a 24-hour period:
- Acute onset of PaO2/FiO2 less than or equal to 300 (adjustments made for altitude where appropriate)
- Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
- Requirement for positive pressure ventilation via endotracheal tube
- No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates
You may not qualify if:
- Neuromuscular disease that impairs ability to ventilate without assistance, (e.g., cervical spinal cord injury at level C5 or higher spinal cord injury amyotrophic lateral sclerosis, Guillain-Barré syndrome or myasthenia gravis)
- Pregnant or breast-feeding
- Severe chronic respiratory disease (i.e., chronic hypercapnia \[PaCO2 greater than 45 mmHg\], chronic hypoxemia \[PaO2 less than 55 mmHg on FiO2 = 0.21\], hospitalization within the last 6 months for respiratory failure \[PaCO2 greater than 50 mm Hg and/or PaO2 less than 55 mmHg on 0.21 FiO2\], secondary polycythemia, severe pulmonary hypertension \[mean PAP (pulmonary artery pressure) greater than 40 mmHg\], or ventilator dependency)
- Burns over greater than 40% of total body surface area
- Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
- Allogeneic bone marrow transplant within the 5 years prior to study entry
- Participant, surrogate, or physician is not committed to full support (Exception: a participant will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
- Severe chronic liver disease (Child-Pugh score of 11-15)
- Diffuse alveolar hemorrhage from vasculitis
- Morbid obesity (greater than 1kg/cm body weight.)
- Unwillingness or inability to utilize the ARDS network 6 ml / kg Predicted Body Weight (PBW) ventilation protocol
- Moribund participant and is not expected to survive 24 hours
- No intent to obtain central venous access for monitoring intravascular pressures
- Contraindication to aerosolized albuterol (see Appendix A.8 of the protocol for more information)
- Daily use (prior to study hospitalization) of inhaled beta agonist, corticosteroid, or oral leukotriene modifier
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
University of San Francisco-Fresno Medical Center
Fresno, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
UCSF-Moffitt Hospital
San Francisco, California, United States
UCSF-San Francisco General Hospital
San Francisco, California, United States
Centura St. Anthony Central Hospital
Denver, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Baton Rouge General Hospital-Blue Bonnet
Baton Rouge, Louisiana, United States
Baton Rouge General Hospital-Midcity
Baton Rouge, Louisiana, United States
Earl K. Long Medical Center
Baton Rouge, Louisiana, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
Medical Center of Louisiana
New Orleans, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Baltimore VA Medical Center
Baltimore, Maryland, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Maryland Shock Trauma Center
Baltimore, Maryland, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Rochester Methodist Hospital
Rochester, Minnesota, United States
St. Mary's Hospital, Mayo Clinic
Rochester, Minnesota, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Durham Regional Medical Center
Durham, North Carolina, United States
Moses Cone Health System
Greensboro, North Carolina, United States
Wesley Long Community Hospital
Greensboro, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
McKay-Dee Hospital
Ogden, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Related Publications (3)
Brown SM, Wilson E, Presson AP, Zhang C, Dinglas VD, Greene T, Hopkins RO, Needham DM; with the National Institutes of Health NHLBI ARDS Network. Predictors of 6-month health utility outcomes in survivors of acute respiratory distress syndrome. Thorax. 2017 Apr;72(4):311-317. doi: 10.1136/thoraxjnl-2016-208560. Epub 2016 Jul 20.
PMID: 27440140DERIVEDAmbrus DB, Benjamin EJ, Bajwa EK, Hibbert KA, Walkey AJ. Risk factors and outcomes associated with new-onset atrial fibrillation during acute respiratory distress syndrome. J Crit Care. 2015 Oct;30(5):994-7. doi: 10.1016/j.jcrc.2015.06.003. Epub 2015 Jun 16.
PMID: 26138630DERIVEDNational Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Matthay MA, Brower RG, Carson S, Douglas IS, Eisner M, Hite D, Holets S, Kallet RH, Liu KD, MacIntyre N, Moss M, Schoenfeld D, Steingrub J, Thompson BT. Randomized, placebo-controlled clinical trial of an aerosolized beta(2)-agonist for treatment of acute lung injury. Am J Respir Crit Care Med. 2011 Sep 1;184(5):561-8. doi: 10.1164/rccm.201012-2090OC.
PMID: 21562125DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Schoenfeld, ARDSNet CCC PI
- Organization
- Acute Respiratory Distress Syndrome (ARDS) Network
Study Officials
- PRINCIPAL INVESTIGATOR
Michael A. Matthay, MD
University of California, San Francisco
- STUDY CHAIR
Roy Brower, MD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2007
First Posted
February 14, 2007
Study Start
August 1, 2007
Primary Completion
September 1, 2008
Study Completion
November 1, 2008
Last Updated
February 10, 2017
Results First Posted
July 15, 2013
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will share
a deidentified database of the ALVEOLI study is available through BioLINCC