Randomized clinical trial of a combination of an inhaled corticosteroid and beta agonist in patients at risk of developing the acute respiratory distress syndrome

Emir Festic, Gordon E. Carr, Rodrigo Cartin-Ceba, Richard F. Hinds, Valerie Banner-Goodspeed, Vikas Bansal, Adijat T. Asuni, Daniel Talmor, Govindarajan Rajagopalan, Ryan D. Frank, Ognjen Gajic, Michael A. Matthay, Joseph E. Levitt

Research output: Contribution to journalArticle

21 Scopus citations

Abstract

Objectives: Effective pharmacologic treatments directly targeting lung injury in patients with the acute respiratory distress syndrome are lacking. Early treatment with inhaled corticosteroids and beta agonists may reduce progression to acute respiratory distress syndrome by reducing lung inflammation and enhancing alveolar fluid clearance. Design: Double-blind, randomized clinical trial (ClinicalTrials.gov: NCT01783821). The primary outcome was longitudinal change in oxygen saturation divided by the Fio2 (S/F) through day 5. We also analyzed categorical change in S/F by greater than 20%. Other outcomes included need for mechanical ventilation and development of acute respiratory distress syndrome. Setting: Five academic centers in the United States. Patients: Adult patients admitted through the emergency department at risk for acute respiratory distress syndrome. Interventions: Aerosolized budesonide/formoterol versus placebo bid for up to 5 days. Measurements and Main Results: Sixty-one patients were enrolled from September 3, 2013, to June 9, 2015. Median time from presentation to first study drug was less than 9 hours. More patients in the control group had shock at enrollment (14 vs 3 patients). The longitudinal increase in S/F was greater in the treatment group (p = 0.02) and independent of shock (p = 0.04). Categorical change in S/F improved (p = 0.01) but not after adjustment for shock (p = 0.15). More patients in the placebo group developed acute respiratory distress syndrome (7 vs 0) and required mechanical ventilation (53% vs 21%). Conclusions: Early treatment with inhaled budesonide/formoterol in patients at risk for acute respiratory distress syndrome is feasible and improved oxygenation as assessed by S/F. These results support further study to test the efficacy of inhaled corticosteroids and beta agonists for prevention of acute respiratory distress syndrome.

Original languageEnglish (US)
Pages (from-to)798-805
Number of pages8
JournalCritical care medicine
Volume45
Issue number5
DOIs
StatePublished - May 1 2017

Keywords

  • Acute lung injury
  • Acute respiratory distress syndrome
  • Budesonide
  • Formoterol
  • Prevention

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

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    Festic, E., Carr, G. E., Cartin-Ceba, R., Hinds, R. F., Banner-Goodspeed, V., Bansal, V., Asuni, A. T., Talmor, D., Rajagopalan, G., Frank, R. D., Gajic, O., Matthay, M. A., & Levitt, J. E. (2017). Randomized clinical trial of a combination of an inhaled corticosteroid and beta agonist in patients at risk of developing the acute respiratory distress syndrome. Critical care medicine, 45(5), 798-805. https://doi.org/10.1097/CCM.0000000000002284