The safety and efficacy of short-term budesonide delivered via mucosal atomization device for chronic rhinosinusitis without nasal polyposis

Authors

  • Andrew Thamboo MD,

    1. Division of Otolaryngology, niversity of British Columbia, St. Paul's Sinus Centre, Vancouver, British Columbia, Canada
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  • Jamil Manji MSc,

    1. Division of Otolaryngology, niversity of British Columbia, St. Paul's Sinus Centre, Vancouver, British Columbia, Canada
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  • András Szeitz PhD,

    1. Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, Canada
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  • Rachelle Dar Santos BSc,

    1. Division of Otolaryngology, niversity of British Columbia, St. Paul's Sinus Centre, Vancouver, British Columbia, Canada
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  • Iain Hathorn MBChB, FRCS (ORL-HNS),

    1. Division of Otolaryngology, niversity of British Columbia, St. Paul's Sinus Centre, Vancouver, British Columbia, Canada
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  • Eng Cern Gan MBBS, MRCS (Edin), MMED (ORL),

    1. Division of Otolaryngology, niversity of British Columbia, St. Paul's Sinus Centre, Vancouver, British Columbia, Canada
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  • Saad Alsaleh MBBS, FRCSC,

    1. Division of Otolaryngology, niversity of British Columbia, St. Paul's Sinus Centre, Vancouver, British Columbia, Canada
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  • Amin R. Javer MD, FRCSC, FARS

    Corresponding author
    1. Division of Otolaryngology, niversity of British Columbia, St. Paul's Sinus Centre, Vancouver, British Columbia, Canada
    • Correspondence to: Amin R. Javer, MD, FRCSC, FARS, St. Paul's Sinus Centre, 1081 Burrard Street, Vancouver, BC, V6Z 1Y6, Canada; e-mail: sinusdoc@me.com

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  • Funding sources for the study: St. Paul's Hospital Foundation, Vancouver, BC, Canada (01866152).

  • Potential conflict of interest: None provided.

  • Public clinical trial registration: http://clinicaltrials.gov/show/NCT01405339. The Effect of Budesonide Spray Via Mucosal Atomization Device on the Hypothalamic-Pituitary Axis: Budesonide Application Via Mucosal Atomization Device as a Treatment for Chronic Rhinosinusitis When Utilized as a Topical Nasal Steroid Spray.

Abstract

Background

Budesonide is a potent corticosteroid commonly prescribed for management of inflammation in chronic rhinosinusitis (CRS). The standard for prescribing budesonide is via impregnated nasal saline irrigation (INSI), although recently the mucosal atomization device (MAD) has emerged as a theoretically superior method of distributing medication into the sinuses. The MAD atomizes medication into small droplets and this is thought to enhance absorption and improve bioavailability. However, no studies have shown whether enhanced absorption and improved bioavailability of budesonide via MAD causes adrenal suppression. The objective of this study is to determine whether budesonide via MAD affects the hypothalamic-pituitary-adrenal (HPA) axis.

Methods

Twenty CRS patients were recruited from a tertiary rhinology clinic and randomized to take budesonide (1 mg) via MAD or via INSI twice a day for 60 days. The adrenocorticotropic hormone (ACTH) stimulation test and 22-item Sinonasal Outcomes Test (SNOT-22) questionnaire were administered on days 1, 30, and 60 of the study. Plasma budesonide and cortisol levels were simultaneously quantified using a high-performance liquid chromatography–tandem mass spectrometry technique.

Results

There was no indication of adrenal suppression in either group (n = 20) based on ACTH stimulation test results nor was there significant plasma budesonide levels detected in either group. Quality of life, as indicated by SNOT-22, did not differ between groups at 60 days (p = 0.404; 95% confidence interval [CI], −37.2 to 15.9), but SNOT-22 scores for patients using MAD did show statistically significant improvement at 60 days compared to baseline (p = 0.02).

Conclusion

The MAD is likely a safe and effective method of delivering budesonide to the sinuses in the short term.

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