176 / 236
Smith et al.
TABLE 1.
Baseline characteristics for cohort with CRS
(n
=
35)
Characteristic
Gender, n (%)
Female
13 (37)
Male
22 (63)
Age (years), mean (range)
49.5 (20–77)
Asthma, n (%)
18 (62)
Allergy, n (%)
13 (45)
ASA intolerance, n (%)
6 (21)
Smoker, n (%)
2 (7)
Nasal polyposis, n (%)
20 (69)
SNOT-22 score presentation, mean
±
SD
49.1
±
21.9
SNOT-22 score follow-up, mean
±
SD
20.5
±
16.9
Sinus CT score (Lund-Mackay), mean (range)
14.3 (4–24)
Duration of budesonide use (months), mean (range)
38.2 (15–96)
Concurrent medication use, n (%)
Inhaled corticosteroids
18 (62)
Intranasal corticosteroid sprays
0 (0)
Ocular corticosteroid drops
0 (0)
Systemic corticosteroids
0 (0)
Oral contraceptive pills
1 (3)
ASA
=
acetylsalicylic acid; CRS
=
chronic rhinosinusitis; CT
=
computed tomog-
raphy; SD
=
standard deviation; SNOT-22
=
22-item Sino-Nasal Outcome Test.
results less than 500 nmol/L and required cosyntropin stim-
ulation testing. Serum
AM
cortisol results are detailed in
Table 2. Of the 19 patients who required cosyntropin stim-
ulation testing, none had abnormal test results (all cortisol
levels greater than 500 nmol/L at 60 minutes).
Discussion
This study examined the effect of long-term (greater
than 12 months) high-volume sinonasal budesonide
irrigations on HPA axis function in patients with CRS.
After a mean of 38.2 months (2.9 years) of twice daily use
of 1 mg per irrigation (2 mg daily dose), there were no de-
tected cases of HPA axis suppression on objective testing.
The results from this study suggest that the long-term use
of sinonasal budesonide irrigations (up to 2.9 years) may
be a safe treatment option in patients with CRS after ESS.
The mean serum
AM
cortisol level was 431.2 nmol/L, with
a range of 128 to 808 nmol/L. Of the 35 patients enrolled
into this study, 19 had serum
AM
cortisol levels that could
not exclude exogenous HPA axis suppression (less than
500 nmol/L). Seventeen of these patients had serum levels
within the normal range, which cannot exclude suppression
TABLE 2.
Hypothalamic pituitary adrenal axis testing
(n
=
35)
Outcome
Morning serum cortisol level
Mean
±
SD (nmol/L)
431.2
±
146.88
Range (nmol/L)
128–808
Normal (n)
a
16
Low (n)
b
2
Nondiagnostic (n)
c
17
250 mcg cosyntropin stimulation test
Normal (n)
d
19
Abnormal (n)
e
0
a
Normal: greater than 500 nmol/L.
b
Low: less than 200 nmol/L, greater than 100 nmol/L.
c
Nondiagnostic: less than 500 nmol/L, greater than 200 nmol/L.
d
Normal: cortisol greater than 500 nmol/L at 60 minutes.
e
Abnormal: cortisol less than 500 nmol/L at 60 minutes.
SD
=
standard deviation.
in patients on prolonged topical steroids. Two patients had
low serum
AM
cortisol levels, which in the general popula-
tion would have prompted further testing but are not di-
agnostic of exogenous suppression (less than 200 nmol/L,
greater than 100 nmol/L). All 19 of these patients went on
to receive normal 250 mcg cosyntropin stimulation tests.
Eighteen patients in this cohort (62%) had a history of
concurrent asthma and were taking inhaled corticosteroids.
Hypothetically, the systemic effects of multiple corticos-
teroids may be cumulative and potentially put this subset
of patients at higher risk for HPA axis suppression. How-
ever, none of these patients had evidence of suppression.
None of the patients were concurrently prescribed oph-
thalmic corticosteroids or intranasal corticosteroid sprays
and as such the cumulative effectives of these medications
of budesonide irrigations cannot be assessed.
The importance of topical intranasal steroids in the man-
agement of CRS is well established.
3,17,20,21
Although the
safety profiles for intranasal steroid sprays are well known,
the greatest drawback of these low-volume sprays is in-
adequate delivery into the paranasal sinuses.
5,6,8,9
High-
volume irrigation techniques have been shown to optimize
delivery of medications into the sinuses and are believed
to offer a better maintenance technique to control mucosal
inflammation.
6,8–10
High-volume irrigation techniques are
now recommended as the primary delivery mechanism for
topical intranasal corticosteroid therapy in patients with
CRS.
11,22
Unfortunately, they remain limited to off-label
agents and lack robust safety profiles.
4
Prolonged topical steroids are associated with a risk of
unintended systemic absorption, which can lead to a vari-
ety of adverse effects such as increased intraocular pres-
sure, glaucoma, osteoporosis, avascular necrosis of the
hip, and HPA axis suppression.
23
However, HPA axis
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