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


CONCLUSIONS
The MAD is likely a safe and effective method of delivering budesonide to the sinuses in the short term.
Division of Otolaryngology, niversity of British Columbia, St. Paul's Sinus Centre, Vancouver, British Columbia, Canada.
Andrew
A
Thamboo
Jamil
J
Manji
András
A
Szeitz
Rachelle Dar
RD
Santos
Iain
I
Hathorn
Eng Cern
EC
Gan
Saad
S
Alsaleh
Amin R
AR
Javer
D058956:Administration, Mucosal; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D002170:Canada; D002908:Chronic Disease; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000378:metabolism; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects; D008297:Male; D009298:Nasal Polyps / Q000150:complications; D009330:Nebulizers and Vaporizers / Q000706:statistics & numerical data; D010913:Pituitary-Adrenal System / Q000187:drug effects; D011446:Prospective Studies; D011788:Quality of Life; D012220:Rhinitis / Q000150:complications / Q000188:drug therapy*; D012852:Sinusitis / Q000150:complications / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D019819:Budesonide; D006854:Hydrocortisone
budesonide; chronic rhinosinusitis; irrigations; mucosal atomization device; quality of life; safety