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OR I G I NAL ART I CLE
Safety of long-term high-volume sinonasal budesonide irrigations
for chronic rhinosinusitis
Kristine A. Smith, MD1, Gabrielle French, BSc2, Bradford Mechor, MD 1 and Luke Rudmik, MD, MSc1
Background: Off-label high-volume sinonasal budesonide
irrigations are commonly used during the management of
chronic rhinosinusitis (CRS). Although short-term use (4 to
8 weeks) has been demonstrated to be safe, the long-term
effects on the hypothalamic-pituitary-adrenal (HPA) axis
remain unclear. The objective of this study is to determine
whether CRS patients using long-term (minimum greater
than 12 months) budesonide sinonasal irrigations have
evidence of HPA axis suppression.
Methods: Patients with CRS being managed with high-
volume sinonasal budesonide irrigations were recruited
from 2 tertiary level rhinology clinics between March 2014
and July 2015. Inclusion criteria were as follows: (1) adult
(age greater than 18 years); (2) guideline-based diagnosis
of CRS; (3) previous endoscopic sinus surgery; (4) min-
imum of twice daily high-volume sinonasal budesonide
irrigation (concentration of 1 mg per irrigation; total daily
dose of 2 mg); and (5) a minimum of 12-month duration. Ex-
clusion criteria included systemic corticosteroid use within
3 months of HPA axis testing. The primary outcomes were
morning (am) serum cortisol levels and, when indicated,
cosyntropin stimulation levels.
Results: A total of 35 patients fulfilled eligibility criteria and
underwent HPA axis testing. Mean duration of budesonide
sinonasal irrigation therapy use was 38.2 months (2.9 years).
The mean ± standard deviation (SD) am serum cortisol
was 431.2 ± 146.9 nmol/L (normal, 200 to 650 nmol/L).
Subsequent cosyntropin stimulation tests, in indicated
patients (n = 19), demonstrated no evidence of HPA axis
suppression.
Conclusion: Outcomes from this study suggest that daily
high-volume sinonasal budesonide irrigations fail to pro-
duce evidence of HPA axis suppression with prolonged
courses lasting longer than 2 years. C 2016 ARS-AAOA, LLC.
Key Words:
chronic rhinosinusitis; sinusitis; medical therapy; safety;
budesonide; topical therapy; corticosteroid; irrigations
How to Cite this Article:
Smith KA, French G, Mechor B, Rudmik L. Safety of
long-term high-volume sinonasal budesonide irrigations
for chronic rhinosinusitis. Int ForumAllergy Rhinol. 2016;6:
228–232.
C hronic rhinosinusitis (CRS) is a common inflammatory
disease of the paranasal sinuses that affects approxi-
mately 5% to 11% of the general population.1,2 Main-
tenance medical therapy is essential for successful long-
term disease control in the majority of CRS patients.3,4
1Division of Otolaryngology–Head and Neck Surgery, Department of
Surgery, University of Calgary, Calgary, Alberta, Canada; 2Faculty of
Medicine, University of Calgary, Calgary, Alberta, Canada
Correspondence to: Luke Rudmik, MD, MSc, Division of
Otolaryngology–Head and Neck Surgery, Department of Surgery, University
of Calgary, Foothills Medical Centre, South Tower Suite 602, 1403 - 29th
St. NW T2N 2T9, Calgary, Alberta, Canada; e-mail:
Potential conflict of interest: None provided.
Presented at the Annual ARS Meeting at the American Academy of
Otolaryngology Meeting on September 25–26, 2015, in Dallas, TX.
Received: 4 September 2015; Revised: 4 November 2015; Accepted:
29 November 2015
DOI: 10.1002/alr.21700
View this article online at
Common medical strategies generally include high-volume
isotonic irrigations and topical intranasal corticosteroids,
as well as systemic corticosteroids, antibiotics, leukotriene
pathway modulators, and allergy control. 3 Adequate de-
livery of topical intranasal corticosteroids continues to be
one of the greatest barriers to decreasing sinonasal mu-
cosal inflammation.5 High-volume irrigation techniques
have been shown to improve the delivery of topical medica-
tions into the paranasal sinuses and this is the recommended
approach for managing patients with CRS, especially those
who have undergone endoscopic sinus surgery (ESS).6–11
As such, the off-label use of budesonide respules mixed into
high-volume saline irrigations has become a common main-
tenance strategy during the management of CRS. However,
given the off-label nature of this treatment, the safety pro-
file has not been as rigorously defined compared to other
U.S. Food and Drug Administration (FDA) approval low-
volume metered-dose corticosteroid sprays.12
International Forum of Allergy & Rhinology, Vol. 6, No. 3, March 2016
Reprinted by permission of Int Forum Allergy Rhinol. 2016; 6(3):228-232.
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