A pilot study of the effects of intranasal budesonide delivered by NasoNeb® on patients with perennial allergic rhinitis

Authors

  • Kristal Brown MD,

    1. Section of Otolaryngology–Head and Neck Surgery, The University of Chicago Medicine and Biological Sciences, Chicago, IL
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  • James Lane BSc,

    1. Section of Otolaryngology–Head and Neck Surgery, The University of Chicago Medicine and Biological Sciences, Chicago, IL
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  • Marianella Paz Silva MD,

    1. Section of Otolaryngology–Head and Neck Surgery, The University of Chicago Medicine and Biological Sciences, Chicago, IL
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  • Marcy DeTineo BSN,

    1. Section of Otolaryngology–Head and Neck Surgery, The University of Chicago Medicine and Biological Sciences, Chicago, IL
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  • Robert M. Naclerio MD,

    1. Section of Otolaryngology–Head and Neck Surgery, The University of Chicago Medicine and Biological Sciences, Chicago, IL
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  • Fuad M. Baroody MD

    Corresponding author
    1. Section of Otolaryngology–Head and Neck Surgery, The University of Chicago Medicine and Biological Sciences, Chicago, IL
    • Correspondence to: Fuad M. Baroody, MD, Section of Otolaryngology–Head and Neck Surgery, The University of Chicago Medicine and Biological Sciences, 5841 S. Maryland Ave, MC1035, Chicago, IL 60637; e-mail: fbaroody@surgery.bsd.uchicago.edu

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  • Funding sources for the study: NasoNeb.

  • Potential conflict of interest: None provided.

  • Public clinical trial registration: http://clinicaltrials.gov/show/NCT01270256. Evaluation of NasoNeb™ Delivery of an Intranasal Steroid in the Treatment of Perennial Allergic Rhinitis.

Abstract

Background

We investigated whether nebulization of budesonide via a NasoNeb® device would treat perennial allergic rhinitis.

Methods

We performed a parallel, randomized, double-blind, placebo-controlled, pilot study in subjects (n = 40) with perennial allergic rhinitis. After recording baseline symptoms, subjects were randomized to budesonide respules (0.25 mg) or an equivalent placebo for 26 days. Nasal peak inspiratory flow (NPIF) and nasal symptoms (graded on a 0–3 scale) were recorded by the subjects twice daily. Rhinoconjunctivitis quality of life (RQOL) as well as nasal volume, measured by acoustic rhinometry, was obtained at baseline, after 2 weeks, and at the end of treatment.

Results

The average change from baseline in symptoms over the treatment period was greater for the group on budesonide (−3.33) compared to placebo (−1.98) (p = 0.45). When the average change from baseline over the treatment period was compared between the groups, budesonide resulted in higher NPIF (36.4 L/min) than placebo (18.7 L/min), p = 0.094. QOL improved in both groups compared to baseline with no significant difference between the groups. Although acoustic rhinometry indicated a larger volume in the group treated with budesonide on the last trial visit, the differences between the groups were not significant when accounting for the baseline values.

Conclusion

Compared to placebo, administration of nebulized budesonide in subjects with perennial allergic rhinitis resulted in improvements in symptoms and objective measures of nasal congestion which approached but did not achieve statistical significance. A higher dose of active agent, a less effective placebo and a larger number of subjects might have improved statistical significance.

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