Safety and effectiveness of albuterol solutions with and without benzalkonium chloride when administered by continuous nebulization

Am J Health Syst Pharm. 2018 Nov 15;75(22):1791-1797. doi: 10.2146/ajhp180154. Epub 2018 Oct 3.

Abstract

Purpose: The results of a study to determine if rates of poor response differ in patients receiving continuous nebulized albuterol (CNA) therapy with or without the preservative benzalkonium chloride are presented.

Methods: A retrospective analysis of the records of all patients who received CNA therapy at a large academic medical center from July 2015 to January 2016 was conducted. Data from patient evaluations performed before and after a change to benzalkonium chloride-containing albuterol were collected. The primary outcome was the rate of poor patient response, defined as a composite endpoint. Secondary outcomes included duration of therapy, dosing requirements, and duration of supplemental oxygen therapy.

Results: There was no significant difference in rates of poor response between patients exposed (n = 80) and patients not exposed (n = 48) to benzalkonium chloride (16% and 17%, respectively; p = 0.95). The cohort not exposed to benzalkonium chloride had a median CNA duration of 7.0 hours, as compared with 10.5 hours for the cohort exposed to benzalkonium chloride, but this difference was not significant (p = 0.19). There were no significant differences between the benzalkonium chloride-exposed and nonexposed cohorts in the maximum dosing requirement (12.6 mg/hr versus 12.8 mg/hr, p = 0.89) or median duration of supplemental oxygen use (27.5 hours versus 16.5 hours, p = 0.77).

Conclusion: A study of hospitalized patients receiving CNA detected no significant difference in the frequency of poor response to therapy between groups receiving benzalkonium chloride-free versus benzalkonium chloride-containing albuterol products.

Keywords: albuterol; asthma; benzalkonium chloride; bronchospasm; preservatives; status asthmaticus.

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Albuterol / administration & dosage
  • Albuterol / adverse effects*
  • Albuterol / therapeutic use
  • Benzalkonium Compounds / administration & dosage
  • Benzalkonium Compounds / adverse effects*
  • Benzalkonium Compounds / therapeutic use
  • Bronchodilator Agents / administration & dosage
  • Bronchodilator Agents / adverse effects*
  • Bronchodilator Agents / therapeutic use
  • Child
  • Female
  • Humans
  • Male
  • Nebulizers and Vaporizers
  • Preservatives, Pharmaceutical / administration & dosage
  • Preservatives, Pharmaceutical / adverse effects*
  • Preservatives, Pharmaceutical / therapeutic use
  • Retrospective Studies
  • Status Asthmaticus / drug therapy
  • Treatment Outcome

Substances

  • Benzalkonium Compounds
  • Bronchodilator Agents
  • Preservatives, Pharmaceutical
  • Albuterol