BACKGROUND: The purpose of this study was to determine whether nebulized bacteriostatic saline, which contains the preservative benzyl alcohol, is an irritant to the tracheobronchial mucosa in healthy adults. METHODS: A randomized, double-blind, placebo-controlled study was conducted with 10 healthy adults who inhaled 3 mL of eitherbacteriostatic saline or saline placeboby nebulizer four times a day for 2 weeks. Pulmonary function tests and bronchoscopy with biopsy were performed immediately before and after the 2-week nebulization period. RESULTS:Nine of 10 volunteers were compliant with the study protocol. Four of five volunteers who used nebulized bacteriostatic saline developed bronchitic symptoms and had bronchoscopic evidence of bronchitis. The fifth remained healthy. Four volunteers used nebulized saline (placebo). Two of these four became ill, one with a much more severe bronchitis than any of the bacteriostatic saline volunteers, and one with pharyngitis. Bronchoscopic biopsies showed a lymphocytic mucosal infiltrate in those who became ill while using nebulized bacteriostatic saline and a polymorphonuclear mucosal infiltrate in those who became ill while using nebulized saline placebo. CONCLUSIONS: Nebulization of bacteriostatic saline, containing benzyl alcohol as its preservative, causes bronchitis in healthy adults. Even nebulization of sterile saline may be associated with bronchitis and pharyngitis. Physicians who prescribe nebulized medications must pay close attention to the bronchodilator diluent.
RCT Entities:
BACKGROUND: The purpose of this study was to determine whether nebulized bacteriostatic saline, which contains the preservative benzyl alcohol, is an irritant to the tracheobronchial mucosa in healthy adults. METHODS: A randomized, double-blind, placebo-controlled study was conducted with 10 healthy adults who inhaled 3 mL of either bacteriostatic saline or saline placebo by nebulizer four times a day for 2 weeks. Pulmonary function tests and bronchoscopy with biopsy were performed immediately before and after the 2-week nebulization period. RESULTS: Nine of 10 volunteers were compliant with the study protocol. Four of five volunteers who used nebulized bacteriostatic saline developed bronchitic symptoms and had bronchoscopic evidence of bronchitis. The fifth remained healthy. Four volunteers used nebulized saline (placebo). Two of these four became ill, one with a much more severe bronchitis than any of the bacteriostatic saline volunteers, and one with pharyngitis. Bronchoscopic biopsies showed a lymphocytic mucosal infiltrate in those who became ill while using nebulized bacteriostatic saline and a polymorphonuclear mucosal infiltrate in those who became ill while using nebulized saline placebo. CONCLUSIONS: Nebulization of bacteriostatic saline, containing benzyl alcohol as its preservative, causes bronchitis in healthy adults. Even nebulization of sterile saline may be associated with bronchitis and pharyngitis. Physicians who prescribe nebulized medications must pay close attention to the bronchodilator diluent.