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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00434993 |
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.
Condition | Intervention | Phase |
---|---|---|
Respiratory Distress Syndrome, Adult |
Drug: Albuterol Sulfate USP Procedure: Mini-Bronchoalveolar Lavage Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Randomized, Multicenter Trial of Aerosolized Albuterol Versus Placebo in Acute Lung Injury |
Enrollment: | 282 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Albuterol Sulfate: Active Comparator |
Drug: Albuterol Sulfate USP
Albuterol sulfate, USP, solution for inhalation will be diluted as follows:
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.
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
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Placebo: Placebo Comparator |
Procedure: Mini-Bronchoalveolar Lavage
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
Drug: Placebo
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. |
Aerosolized beta-2 agonist therapy is anticipated to diminish the formation of lung edema, enhance clearance of lung edema and decrease pulmonary inflammation in patients with acute lung injury. Because beta-2 agonists have been shown to reduce permeability induced lung injury, it is anticipated that the severity of lung injury will be reduced by aerosolized beta-2 agonist therapy. The therapy may work by enhancing resolution of pulmonary edema by upregulating alveolar epithelial fluid transport mechanisms that will in turn enhance the clearance of alveolar edema. A reduction in the severity of lung injury and the quantity of alveolar edema should result in earlier extubation and more ventilator free days, improved pulmonary oxygen uptake, and improved lung compliance.
Study design: phase II/III prospective, randomized double-blind, placebo controlled trial.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must meet the following three criteria within a 24-hour period:
Exclusion Criteria:
Principal Investigator: | Michael A. Matthay, MD | University of California, San Francisco |
Study Chair: | Roy Brower, MD | Johns Hopkins University |
Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) ( Andrea Harabin, PhD ) |
Study ID Numbers: | 474, N01 HR056179, HHSN268200536179C |
Study First Received: | January 29, 2007 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00434993 History of Changes |
Health Authority: | United States: Federal Government |
Acute Lung Injury Acute Respiratory Distress Syndrome Albuterol |
Aerosolized Critical Care Ventilator |
Neurotransmitter Agents Adrenergic Agents Adrenergic beta-Agonists Respiratory Distress Syndrome, Adult Respiration Disorders Albuterol Acute Respiratory Distress Syndrome |
Anti-Asthmatic Agents Adrenergic Agonists Respiratory Tract Diseases Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents |
Respiratory System Agents Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists Respiratory Distress Syndrome, Adult Respiration Disorders Albuterol Physiological Effects of Drugs Anti-Asthmatic Agents Reproductive Control Agents |
Adrenergic Agonists Pharmacologic Actions Pathologic Processes Tocolytic Agents Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Syndrome Lung Diseases Peripheral Nervous System Agents Bronchodilator Agents |