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Original Research
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of adherence to ICS
1
OM treatment, since no over-
sight of adherence was implemented in this clinical
population.
There are multiple methodologic limitations that pre-
clude assertive affirmations on the efficacy of ICS
1
OM
treatment in mild pediatric OSA. The retrospective
nature of the study and the uncontrolled and open-label
approach that are inherent to the clinical practice set-
ting in which ICS
1
OM was administered markedly
reduce the level of evidence and of the strength of
potential recommendations that can be derived from
this study.
34,35
Nevertheless, the absence of significant
side effects and the overall favorable safety profile asso-
ciated with the use of either ICS
36-38
or OM
39
and the
possibility that based on the current encouraging results
reported herein ICS
1
OM may ultimately replace T&A
as the first line of treatment in mild OSA, provides
major impetus for future, large-scale, multicenter RCTs.
In summary, the retrospective analysis of our clinical
experience associated with the implementation of ICS
and OM in the management of mild OSA in children as
an alternative to T&A is highly encouraging and sup-
ports prospective evaluation of this treatment modality
as a potential alternative to T&A.
Acknowledgments
Author contributions:
D. G. had full access
to all of the data in the study and takes respon-
sibility for the integrity of the data and the
accuracy of the data analysis. L. K.-G. was
principal author of the manuscript. L. K.-G.
and D. G. contributed to the conceptual
framework for the study; L. K.-G. and D. G.
contributed to data analysis; L. K.-G., R. B.,
and H. P. R. B. contributed to data acquisi-
tion; L. K.-G., R. B., H. P. R. B., and D. G.
contributed to data interpretation; L. K.-G.
drafted the initial manuscript; R. B. and
H. P. R. B. contributed to the revision of the
manuscript; D. G. provided critical editing of
the initial manuscript; D. G. is responsible
for the financial support of the project; and
L. K.-G., R. B., H. P. R. B., and D. G. approved
the final manuscript.
Financial/nonfinancial disclosures:
The
authors have reported to
CHEST
the
following conflicts of interest: Dr Kheirandish-
Gozal is the recipient of an investigator-
initiated grant from Merck & Co Inc on the
effect of montelukast in the treatment of
pediatric sleep apnea. Dr Gozal is the recipi-
ent of an investigator-initiated grant from
ResMed Corp on urine biomarkers in adult
sleep apnea. Drs Bhattacharjee and Bandla
have reported that no potential conflicts of
interest exist with any companies/organiza-
tions whose products or services may be
discussed in this article.
Role of sponsors:
The sponsor had no role in
the design of the study, the collection and
analysis of the data, or the preparation of the
manuscript.
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