Salbutamol Nebulization During Noninvasive Ventilation in Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial

J Aerosol Med Pulm Drug Deliv. 2019 Jun;32(3):149-155. doi: 10.1089/jamp.2018.1484. Epub 2018 Dec 27.

Abstract

Background: Although nebulizing beta 2-agonists during noninvasive ventilation (NIV) could prove helpful, this administration route has to date never been studied in unstable chronic obstructive pulmonary disease (COPD) patients. We sought to demonstrate that salbutamol could be nebulized through an NIV circuit in COPD exacerbation and improve forced expiratory volume in 1 second (FEV1) as compared with placebo. Patient and Methods: This is a bench study to determine the optimal pattern of nebulization followed by a randomized double-blind parallel-group trial comparing salbutamol and placebo aerosols delivered during NIV to 43 intensive care unit patients. Aerosols were generated by a vibrating mesh nebulizer positioned just after the Y-piece. Spirometry was performed immediately before and at several predetermined time points after nebulization. Clinical and biological safety parameters were recorded. Results: We failed to demonstrate a difference between salbutamol and placebo when changes in FEV1 were assessed immediately after nebulization (-20 vs. -35 mL, p = 0.66). However, FEV1 increased significantly from baseline to 40 minutes after the end of salbutamol nebulization, as compared with placebo (+30 vs. -50 mL, p = 0.04). Nebulization was well tolerated. Conclusion: When assessing FEV1 changes 40 minutes after the end of 5 mg salbutamol nebulization in patients undergoing NIV, we observed a slight improvement that was statistically significant compared with the changes observed with an equivalent saline volume.

Trial registration: ClinicalTrials.gov NCT01958814.

Keywords: FEV1; mechanical ventilation; point-of-care spirometry; β2-agonist.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adrenergic beta-2 Receptor Agonists / administration & dosage
  • Adrenergic beta-2 Receptor Agonists / pharmacology
  • Aerosols
  • Aged
  • Albuterol / administration & dosage*
  • Albuterol / pharmacology
  • Bronchodilator Agents / administration & dosage*
  • Bronchodilator Agents / pharmacology
  • Double-Blind Method
  • Female
  • Forced Expiratory Volume
  • Humans
  • Male
  • Middle Aged
  • Nebulizers and Vaporizers
  • Noninvasive Ventilation*
  • Pulmonary Disease, Chronic Obstructive / drug therapy*
  • Pulmonary Disease, Chronic Obstructive / physiopathology
  • Spirometry

Substances

  • Adrenergic beta-2 Receptor Agonists
  • Aerosols
  • Bronchodilator Agents
  • Albuterol

Associated data

  • ClinicalTrials.gov/NCT01958814