• Gavin D Perkins, Simon Gates, Daniel Park, Fang Gao, Chris Knox, Ben Holloway, Daniel F McAuley, James Ryan, Joseph Marzouk, Matthew W Cooke, Sarah E Lamb, David R Thickett, and BALTI-Prevention Collaborators.
• 1 Heart of England NHS Foundation Trust, Bordesley Green East, Birmingham, United Kingdom.
• Am. J. Respir. Crit. Care Med. 2014 Mar 15; 189 (6): 674-83.

RationaleExperimental studies suggest that pretreatment with β-agonists might prevent acute lung injury (ALI).ObjectivesTo determine if in adult patients undergoing elective esophagectomy, perioperative treatment with inhaled β-agonists effects the development of early ALI.MethodsWe conducted a randomized placebo-controlled trial in 12 UK centers (2008-2011). Adult patients undergoing elective esophagectomy were allocated to prerandomized, sequentially numbered treatment packs containing inhaled salmeterol (100 μg twice daily) or a matching placebo. Patients, clinicians, and researchers were masked to treatment allocation. The primary outcome was development of ALI within 72 hours of surgery. Secondary outcomes were ALI within 28 days, organ failure, adverse events, survival, and health-related quality of life. An exploratory substudy measured biomarkers of alveolar-capillary inflammation and injury.Measurements And Main ResultsA total of 179 patients were randomized to salmeterol and 183 to placebo. Baseline characteristics were similar. Treatment with salmeterol did not prevent early lung injury (32 [19.2%] of 168 vs. 27 [16.0%] of 170; odds ratio [OR], 1.25; 95% confidence interval [CI], 0.71-2.22). There was no difference in organ failure, survival, or health-related quality of life. Adverse events were less frequent in the salmeterol group (55 vs. 70; OR, 0.63; 95% CI, 0.39-0.99), predominantly because of a lower number of pneumonia (7 vs. 17; OR, 0.39; 95% CI, 0.16-0.96). Salmeterol reduced some biomarkers of alveolar inflammation and epithelial injury.ConclusionPerioperative treatment with inhaled salmeterol was well tolerated but did not prevent ALI. Clinical trial registered with International Standard Randomized Controlled Trial Register (ISRCTN47481946) and European Union database of randomized Controlled Trials (EudraCT 2007-004096-19).

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