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

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, B. Taylor Thompson

Research output: Contribution to journalArticle

Abstract

Rationale: β2-Adrenergic receptor agonists accelerate resolution of pulmonary edema in experimental and clinical studies. Objectives: This 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). Methods: We conducted a multicenter, randomized, placebocontrolled 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 Results: Ventilator-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 thedifference,-4.0 to14.7%;P=0.30). In the subset of patients with shock before randomization, the number of ventilator-free days was lower with albuterol, althoughmortalitywas 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. Conclusions: These 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).

Original languageEnglish (US)
Pages (from-to)561-568
Number of pages8
JournalAmerican journal of respiratory and critical care medicine
Volume184
Issue number5
DOIs
StatePublished - Sep 1 2011

Keywords

  • Acute respiratory distress syndrome
  • Alveolar epithelium
  • Pulmonary edema

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Critical Care and Intensive Care Medicine

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  • Cite this

    Matthay, M. A., Brower, R. G., Carson, S., Douglas, I. S., Eisner, M., Hite, D., Holets, S., Kallet, R. H., Liu, K. D., MacIntyre, N., Moss, M., Schoenfeld, D., Steingrub, J., & Thompson, B. T. (2011). Randomized, placebo-controlled clinical trial of an aerosolized β2-agonist for treatment of acute lung injury. American journal of respiratory and critical care medicine, 184(5), 561-568. https://doi.org/10.1164/rccm.201012-2090OC