• Am. J. Respir. Crit. Care Med. · Sep 2011

    Randomized Controlled Trial Multicenter Study Comparative Study

    Randomized, placebo-controlled clinical trial of an aerosolized β₂-agonist for treatment of acute lung injury.

    • National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network, Michael A Matthay, Roy G Brower, Shannon Carson, Ivor S Douglas, Mark Eisner, Duncan Hite, Steven Holets, Richard H Kallet, Kathleen D Liu, Neil MacIntyre, Marc Moss, David Schoenfeld, Jay Steingrub, and B Taylor Thompson.
    • Am. J. Respir. Crit. Care Med.. 2011 Sep 1;184(5):561-8.

    Rationaleβ₂-Adrenergic receptor agonists accelerate resolution of pulmonary edema in experimental and clinical studies.ObjectivesThis clinical trial was designed to test the hypothesis that an aerosolized β₂-agonist, albuterol, would improve clinical outcomes in patients with acute lung injury (ALI).MethodsWe conducted a multicenter, randomized, placebo-controlled clinical trial in which 282 patients with ALI receiving mechanical ventilation were randomized to receive aerosolized albuterol (5 mg) or saline placebo every 4 hours for up to 10 days. The primary outcome variable for the trial was ventilator-free days.Measurements And Main ResultsVentilator-free days were not significantly different between the albuterol and placebo groups (means of 14.4 and 16.6 d, respectively; 95% confidence interval for the difference, -4.7 to 0.3 d; P = 0.087). Rates of death before hospital discharge were not significantly different between the albuterol and placebo groups (23.0 and 17.7%, respectively; 95%confidence interval for the difference,-4.0 to 14.7%;P = 0.30). In the subset of patients with shock before randomization, the number of ventilator-free days was lower with albuterol, although mortality was not different. Overall, heart rates were significantly higher in the albuterol group by approximately 4 beats/minute in the first 2 days after randomization, but rates of new atrial fibrillation (10% in both groups) and other cardiac dysrhythmias were not significantly different.ConclusionsThese results suggest that aerosolized albuterol does not improve clinical outcomes in patients with ALI. Routine use of β₂-agonist therapy in mechanically ventilated patients with ALI cannot be recommended. Clinical trial registered with www.clinicaltrials.gov (NCT 00434993).

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