OBJECTIVE: Evidence in vitro suggests that benzalkonium chloride, a preservative in many intranasal preparations, interferes with ciliary function and thus could potentially interfere with mucociliary transport, the mechanism for clearing secretions from the nasal cavity. STUDY DESIGN: We performed a parallel randomized study with 10 subjects in each arm comparingRhinocort AQUA (an intranasal steroid [budesonide] spray without benzalkonium chloride) and Nasonex (an intranasal steroid [mometasone furoate] spray with benzalkonium chloride). Before and after 2 weeks of treatment, subjects completed a Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and underwent a measurement of nasal clearance of a radioactive colloidal spray into the nose. RESULTS: The groups were matched at entry for nasal clearance, even though there was variability among subjects. The amount of change after 2 weeks of treatment (Delta before versus after treatment) showed a significant difference in nasal clearance favoring budesonide. After 2 weeks of treatment, both budesonide and mometasone demonstrated overall improvement in quality of life as assessed by the RQLQ. Both treatments were well tolerated. CONCLUSION: Our study extends the observation in vitro that demonstrates the adverse effect of benzalkonium chloride on cilia to a measurement in vivo of clearance. The effects after 2 weeks might not reflect changes after longer periods of treatment. SIGNIFICANCE: To determine the clinical significance of the small improvement in mucociliary transport will require large clinical trials.
RCT Entities:
OBJECTIVE: Evidence in vitro suggests that benzalkonium chloride, a preservative in many intranasal preparations, interferes with ciliary function and thus could potentially interfere with mucociliary transport, the mechanism for clearing secretions from the nasal cavity. STUDY DESIGN: We performed a parallel randomized study with 10 subjects in each arm comparing Rhinocort AQUA (an intranasal steroid [budesonide] spray without benzalkonium chloride) and Nasonex (an intranasal steroid [mometasone furoate] spray with benzalkonium chloride). Before and after 2 weeks of treatment, subjects completed a Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and underwent a measurement of nasal clearance of a radioactive colloidal spray into the nose. RESULTS: The groups were matched at entry for nasal clearance, even though there was variability among subjects. The amount of change after 2 weeks of treatment (Delta before versus after treatment) showed a significant difference in nasal clearance favoring budesonide. After 2 weeks of treatment, both budesonide and mometasone demonstrated overall improvement in quality of life as assessed by the RQLQ. Both treatments were well tolerated. CONCLUSION: Our study extends the observation in vitro that demonstrates the adverse effect of benzalkonium chloride on cilia to a measurement in vivo of clearance. The effects after 2 weeks might not reflect changes after longer periods of treatment. SIGNIFICANCE: To determine the clinical significance of the small improvement in mucociliary transport will require large clinical trials.
Authors: D Häussler; J U Sommer; A Nastev; C Aderhold; A Wenzel; B Kramer; B A Stuck; R Birk Journal: Eur Arch Otorhinolaryngol Date: 2018-04-19 Impact factor: 2.503