The beta agonist lung injury trial prevention. A randomized controlled trial

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, BALTI-Prevention Collaborators

Research output: Contribution to journalArticlepeer-review

43 Citations (Scopus)


RATIONALE: Experimental studies suggest that pretreatment with β-agonists might prevent acute lung injury (ALI).

OBJECTIVES: To determine if in adult patients undergoing elective esophagectomy, perioperative treatment with inhaled β-agonists effects the development of early ALI.

METHODS: We 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 RESULTS: A 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.

CONCLUSION: Perioperative 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).

Original languageEnglish
Pages (from-to)674-83
Number of pages10
JournalAmerican Journal of Respiratory and Critical Care Medicine
Issue number6
Early online date6 Jan 2014
Publication statusPublished - 15 Mar 2014


  • Acute Lung Injury
  • Administration, Inhalation
  • Adrenergic beta-2 Receptor Agonists
  • Adult
  • Aged
  • Albuterol
  • Drug Administration Schedule
  • Elective Surgical Procedures
  • Esophagectomy
  • Female
  • Humans
  • Intention to Treat Analysis
  • Logistic Models
  • Male
  • Middle Aged
  • Perioperative Care
  • Postoperative Complications
  • Treatment Outcome


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