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A comparison of nasal clearance after treatment of perennial allergic rhinitis with budesonide and mometasone.

Author(s): Naclerio RM, Baroody FM, Bidani N, De Tineo M, Penney BC

Affiliation(s): Sections of Otolaryngology-Head and Neck Surgery and Nuclear Medicine, The Pritzker School of Medicine, The University of Chicago, Chicago, IL 60637, USA. rnaclerio@surgery.bsd.uchicago.edu

Publication date & source: 2003-02, Otolaryngol Head Neck Surg., 128(2):220-7.

Publication type: Clinical Trial; Randomized Controlled Trial

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.

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