Intranasal steroids in adenoid hypertrophy and sleep disordered breathing in children

Suparat Sirivimonpan,MD.
23/11/2012

Intranasal corticosteroid(INS)
• since 1974
• extremely effective in reducing the nasal symptoms
of sneezing, itching, rhinorrhea, and nasal
congestion
• firstline treatment choice for patients with rhinitis,
esp. persistent or more severe symptoms
• effective treatments for
– AR,NAR , rhinosinusitis, and nasal polyposis
– Adenoid hypertrophy?? , Snoring??, OSA ??
• nasal and oropharyngeal mucosal inflammation is
present in patients with OSAS

Allergy 2008: 63: 1292–1300
Immunol Allergy Clin N Am 31 (2011) 545–560

OSAS (obstructive sleep apnea syndrome)

• disorder of breathing during sleep characterized by
– prolonged partial upper airway obstruction
– and/or intermittent complete obstruction
(obstructive apnea)
– that disrupts normal ventilation during sleep and
normal sleep patterns
• prevalence of OSAS (Children) in the range of 1-5%
(relatively common disease)

• obesity being an independent risk factor

Pediatrics 2012;130:e714–e755

Seminars in Anesthesia, Perioperative Medicine and Pain (2006) 25, 109-116

Otolaryngol Clin N Am 45 (2012) 1055–1069

OSAS
• Adenotonsillar hypertrophy is the most common
cause of OSAS
• adenotonsillectomy (AT) : primary treatment 
recurrence
• postoperative PSG should be performed to ensure
that OSAS has resolved
• postoperative complications : haemorrhage, airway
obstruction secondary to edema, prolonged
muscular paralysis and palato-pharyngeal
insufficiency

The Cochrane Library 2010, Issue 10

OSAS
• CPAP was effective in the treatment of OSAS, but
adherence is a major barrier
• In less severe cases, non-surgical interventions
may be considered, however few medical
alternatives are currently available

The Cochrane Library 2010, Issue 10

• 2-stage, randomized, placebo-controlled trial
• 60 children : AH and referred for exclusive adenoidectomy

Exclusion criteria :
-concomitant tonsillar hypertrophy
Inclusion criteria -positive history of allergy or atopy
(1) adenoid pad occluding 75% of -URI within the past 2 weeks
nasopharynx(nasal endoscopy) -nasal anatomic anomalies
(2) age between 3 and 7 years -sinonasal diseases (ex. polyposis)
(3) symptoms consistent with AH -craniofacial malformations
lasting 12 months -genetic diseases
(4) no previous adenoidectomy -neurologic disorders
-cardiovascular diseases
-immunodeficiency
-history of epistaxis
-hypersensitivity to steroids
-intranasal, topical, or systemic steroid or
Pediatrics 2007;119;e1392 antibiotic treatment within the past 4 weeks

60 patients

group A group B
first stage
30 patients 30 patients

Mometasone (50 mcg/nostril/day) placebo 40 days
assessment
3 patients did not complete the study
1: systemic steroid (acute ethmoiditis) Nonresponders and placebo-treated
1 : lost to follow-up monitoring Patients  adenoidectomy
1 : dropped out

Responders (21 27pts) (77%)
second stage

group A1 group A2
11 pts 10 pts
MF alternate days , daily MF , 3 months
first 2 weeks per month first 2 weeks per month
Pediatrics 2007;119;e1392

• physical evaluation and nasal endoscopy
• clinical history
– parents with a questionnaire
– age, gender, weight, history and family history of atopy
or allergy, and use of drugs
• Symptoms such as nasal obstruction, rhinorrhea, cough,
snoring, and obstructive sleep apnea were also
– clinical scoring system ranging from 0 to 3
– (0 absent; 1 occasional; 2 frequent; 3 daytime and
nighttime symptoms)
– score related to severity
• parents reported on their children’s symptoms and eventual
adverse effects (eg, nasal bleeding)
• Compliance with drug administration was assessed biweekly
in telephone interviews with parents


No patient
-personal or family history of allergy or atopy
-undergone previous surgery
-received any drugs in the past 4 weeks
-immunodeficiencies


• chronic nasal obstruction improved significantly in
group A (mean overall symptom score: 3)
• unchanged in group B (mean overall symptom score: 9)
• Adenoid size also decreased significantly in patients
given MF (mean choanal obstruction: 64%)


it is difficult to attribute the true value to these
results because of the small number of patients studied


• no significant differences in symptom scores were
observed between the 2 subgroups (A1,A2)
• mean choanal obstruction in group A2 was less than
that in group A1 (56% vs 65.5%;P .001)
• daily administration of MF for 2 weeks per month
seems to decrease AH further

• only 1 complication (episodic epistaxis)
• Compliance with therapy during the last 3-month
period was satisfactory in both subarms

Conclusion
• Topical intranasal MF therapy can be considered a
good therapeutic option to decrease AH
• Nasal administration is safe, reproducible, easily
performed, and well tolerated by pediatric
patients
• Daily use for 2 weeks per month after an initial
40-day-period treatment seems to be the ideal
maintenance schedule
• indications for adenoidectomy remain unchanged
for nonresponders

International Journal of Pediatric Otorhinolaryngology (2008) 72, 1171—1175

60 patients

group A group B
first stage
30 patients 30 patients

Mometasone (50 mcg/nostrilday) placebo 40 days
assessment
3 patients did not complete the study
1: systemic steroid (acute ethmoiditis) Nonresponders and placebo-treated
1 : lost to follow-up monitoring Patients  adenoidectomy
1 : dropped out

Responders (21 27pts) (77%)
second stage

group A1 group A2
11 pts 10 pts
MF alternate days , daily MF , 3 months
first 2 weeks per month first 2 weeks per month

• maintenance therapy : MF aqueous nasal spray (50 mcg) in
each nostril daily for first 2 weeks of every month
• During follow-up visits, parents or legal guardians reported
– duration of maintenance therapy
– eventual adenoid surgical treatment

• Based on this information, divided into 3 subgroups:
(1) children voluntarily suspending maintenance therapy and
requiring surgery (Group A)
(2) children continuing maintenance therapy but needing
surgery (Group B)
(3) children continuing maintenance therapy but not
undergoing surgery (Group C)


• assessment performed after first 4 months of treatment
(previous trial)  clinical and endoscopic baseline

• clinical picture including nasal obstruction, rhinorrhea,
cough, snoring, and obstructive sleep apnea, and
adenoid size were evaluated before the surgical
procedure and at the last follow-up visit in the surgical
groups
• clinical and/or endoscopic evaluation
– Nasal chronic obstructive symptoms : clinical score
(0-3)
– AH size was assessed by means of nasal endoscopy


• 21 children : responders - included in study
• 12 males and 9 females
• mean age of 7±1.6 years


A : surgery , no INS : 6 pts
Group A : voluntarily suspended maintenance therapy within a few B : INS and Surgery : 3 pts
months (range: 1—3 months) after the first period of treatment C : INS , no surgery : 12 pts

Group B :
- 2 adenoidectomy , 1 patients adenoidectomy combined with transtympanic
drainage
- nasal endoscopic examination revealed mild AH close to the Eustachian tube
- Chronic obstructive nasal symptoms and adenoid pad size were unchanged
compared to baseline data

Group C :
- further significant improvement
-Maintenance therapy was stopped definitively after a mean period treatment
of 23 months (range: 15—31 months)


• Intranasal MF treatment was broken off due to poor compliance
by parents or legal guardians (group A)
– significant worsening of nasal chronic obstructive symptoms
and an increase of adenoid size  surgical treatment
• regular continuity  successful results
• longterm therapy is safe and well tolerated by pediatric patients
– No side effects were observed after a mean follow-up of 28
months (range: 6—36 months)

• A multicenter, prospective, randomized study is warranted to
confirm definitively the efficacy of nasal MF


mometasone furoate

Clinical and Experimental Otorhinolaryngology Vol. 4, No. 1: 27-32, March 2011

• prospective, observational study
• 2-11 year-old children
• Sleep-disordered breathing (SDB) : ranging from primary snoring to
OSAS

Inclusion criteria
• 1) history of habitual snoring for the last 3 months or longer
• 2) adenoid hypertrophy confirmed with simple X-ray findings or
endoscopic examination by otolaryngologist

Exclusion criteria
• 1) presence of symptoms of acute respiratory infection
• 2) use of nasal or systemic corticosteroid or antibiotics within 4
weeks prior to the study
• 3) prior tonsil or adenoid surgery
• 4) history of craniofacial, neuromuscular, or genetic disorders

• All patients received 4 weeks course of single intranasal
administration in each nostril with mometasone furoate (100 μg)
• Assessment :
– history and physical examination (BW,height)
– parental questionnaire (OSA-18)
– sinus Xray, adenoid X-ray
– skin prick test or Pharmacia CAP system for detecting allergy

• Allergic rhinitis was diagnosed in case that each child
complaining typical allergic symptoms showed positive result in
allergic test
• After 4 weeks course  re-assess


• presence of allergy (P=0.065) and obesity
(P=0.851) didn’t affect the effect of nasal steroid
on total OSA-18 score

• no significant change in body weight between
before and after treatment (P=0.954)

• Change in OSA-18 score showed no significant
difference according to presence of sinusitis
(P=0.488)


Limitation
• could not have a control group due to lack of
consent
• didn’t confirm the increased nasal airway patency
with objective tool
– under 5 years old  impossible to get patient’s
cooperation during acoustic rhinometry


Conclusion
• 4-weeks course of INS (mometasone furoate) can be a
effective treatment option in pediatric SDB patients
without significant complications
• this treatment works effectively regardless of allergic
status, sinusitis, and obesity
• improvement in quality of life of SDB children is due to
not only decreased AN ratio but also other factors such
as increase nasal airway patency
• Considering this result, intranasal steroid can be used
in SDB children regardless of allergic status or sinusitis


International Journal of Pediatric Otorhinolaryngology 76 (2012) 829–831

• study aims :
– compare the effect of environmental prophylaxis
and nasal saline douching to nasal mometasone
furoate in children with adenoid hypertrophy,
regarding:
• improvement of specific respiratory and nasal
symptoms
• objective reduction of adenoid tissue area

• Children aged 4–8 years with previous diagnosis of
adenoid hypertrophy


• Inclusion criteria
– symptoms of nasal obstruction and snoring and previous
nasoendoscopy or lateral X-ray suggestive of adenoid
hypertrophy

• Exclusion criteria
– use of topical or systemic corticosteroid, antihistamine
or antibiotics for at least 2 months at first consultation
– viral or bacterial upper airways infection at the
previous month
– Immunodeficiency
– patients with nasal septal deviation
– systemic diseases, such as cystic fibrosis or facial
malformation


0 (absent)
• questionnaire on the symptoms nasal obstruction, snoring, 1 (mild)
rhinorrhea, sneezing and itching main purpose of this study design was to
2 (moderate)
3 (severe)
minimize the interference of confusing
• all the children : prick test for respiratorymacro-environment factors
external allergens, nasoendoscopy
(such as home, school, habits and
exposure to allergens)
NSS douching + environmental prophylaxis
(general and specific allergens) 40 days

symptoms questionnaire and
to nasoendoscopy

topical mometasone furoate
(50 mcg/(nostril day) 40 days

symptoms questionnaire and
adenoid area in relation to
to nasoendoscopy the nasopharyngeal area


• 60 children were initially selected
• 51 concluded the study
– 34 (66.6%) males VS 17 (33.3%) females
– Mean age (SD) was 6.43±1.47

– 24 patients (47.05%) : positive prick test to at least
one allergen,
– 27 (52.95%) : non-atopic


MF significantly decreased from prior
treatment and after saline douching
(obstruction and snoring)
severe obstruction


MF significantly decreased from prior
treatment and after saline douching
(obstruction and snoring)

moderate irritative nasal symptoms


NSS irrigation : reduction was not MF : significantly lower than
significantly different from that detected at the other two
before treatment time points


Conclusion
Nasal douching and environmental prophylaxis
• Significantly improved nasal symptoms, snoring and all related
symptoms
due to improved nasal clearance, decreased mucosal edema
and increased nasal permeability.
• but did not influence on adenoid tissue area

Mometasone furoate
•additionally improved clinical symptoms and reduced adenoid
hypertrophy when compared to exclusive nasal saline douching
combined with environmental prophylaxis;
•also significantly reduced the adenoid area in relation to the
nasopharynx, in an objective evaluation

• prospective, randomized, placebo-controlled study

Inclusion criteria
• adenotonsillectomy-indicated patients
• having symptoms associated with adenoid
hypertrophy for at least 6 months


Exclusion criteria
• adenoidectomy previously
• URI or allergic rhinitis or turbinate hypertrophy
• had taken intranasal topical or systemic steroid in the last 1 year
• taken any intranasal medical treatment
• history of chronic nose-bleeding
• Immunodeficiency
• history of hypersensitivity, positive allergy or atopy against
fluticasone
• tonsillar hypertrophy
• chronic otitis media with effusion
• anatomic deformity in noise or sinonasal diseases
• Craniofacial abnormalities such as cleft lip/cleft palate
• genetic diseases (Down Syndrome)
• neurological diseases
• cardiovascular diseases

• randomly divided into two groups
– fluticasone propionate nasal drops of 400
mcg/day for 8 weeks (NSD- nasal steroid drop)
– normal saline (NS) in the same way
• follow-up every 4 weeks
• No patient discontinuation occurred during the
study


• symptoms of nasal airway obstruction were assessed
(0,8 wk)
• fiberendoscopic images or rigid nasal endoscopic images

• using the nasal passage way, choanal openings from top to
bottom were graded (grade 1–4)
– 1st grade: only top segment of choana is obstructed <%25
– 2nd grade: upper half of the choana is obstructed <%50
– 3rd grade: lying to the rhinopharynx and tuba opening is
partially obstructed <%75
– 4th grade: choana is almost completely obstructed


• Before the treatment there was no statistically significant difference between the NSD
and NS group
• Statistically significant improvement (p < 0.05) was observed in the NSD treated group
compared to the NS treated group

no statistically significant difference observed between the two
groups, in terms of their tonsil size

NSD treatment
• 19/25 patients(76%) : no longer a need for surgery
• Adenoidectomy 3 patients (12%)
• 3 patients (12%) were informed of their ongoing need for
surgery but their parents refused the surgery declaring that
NSD had sufficiently improved their conditions

Normal saline treatment
• 16/20(80%) : need for surgery
• 4 patients postponed their adenoidectomy at the request of
their parents for further monitoring in spite of persistant
surgical indication


• Improvement in nasal airway obstruction symptoms
– effect of intranasal corticosteroids on adenoid size
– reduce soft tissues of inferior turbinate

• Intranasal steroid in drop form provides a better spread
in the nasal cavity and reaches the nasopharynx and
pharynx faster
• Disadvantages : application position is uncomfortable
• No complaints regarding usage have been reported by
the patients in this study

• only 1 case of episodic nose-bleeding and 1 sneezing


Conclusion
• This method provides an effective alternative to
surgical treatment in children with adenoid
hypertrophy
• Intranasal corticosteroids are well tolerated by
children

• however, the most appropriate drug, the most efficient
dose and optimal treatment duration continue to be
investigated and determined by way of further
prospective and randomized studies


• randomized, double-blind, crossover design

Inclusion criteria
• Children 6-12 years
• habitual snoring, and on initial overnight polysomnographic
assessment (PSG-1) fulfilled the criteria for mild OSAS
– AHI 3-7 per hour of TST
– Or AHI of 2 per hour of TST but in the presence of a
respiratory arousal index (RAI) of 2 per hour of TST and
nadir oxygen saturation 85%


Patients with a history of allergic rhinitis were
Exclusion criteria also included
• asthma that required chronic preventive therapy
• hypersensitivity to budesonide
• recent nasal trauma
• nasal surgery or nasal septum perforation
• Current therapy with drugs that interact with budesonide
(erythromycin, clarythromycin, ketoconazole, and cimetidine)
• known immunodeficiency or undergoing immunosuppressant
therapy
• craniofacial, neuromuscular, syndromic, or defined genetic
abnormalities
• URI; systemic corticosteroidtherapy; or antibiotic therapy in the 2
weeks before the initiation of the study
• children who already had had T&A in the past 12 months


topical budesonide
(32mcg/puff/nostril
[total 64 mcg]

Total 62
placebo spray N=43
[saline]) OD
19 withdraw
(14 placebo ,5 budesonide)
7 unwillingness to continue INS
6 marked improvement (5/6 budesonide)
6 decided to pursue T&A (all placebo)


antihistaminic medications
or immunotherapy
for allergic symptoms was
recorded for 23 children


intranasal budesonide :
-significant improvements in several PSG abnormalities, namely OAHI, RAI, and nadir SpO2
-along with significant changes in some measures that pertain to sleep macroarchitecture, such as sleep latency, and the
percentage of TST spent in either slow-wave sleep or rapid-eye-movement sleep

Significant reductions in adenoid size occurred with decreases in adenoidal nasopharyngeal ratio
(N/P) ratio from 0.71±0.02 before treatment to 0.57±0.02 after 6 weeks of budesonide therapy
(P .0001)
54.1% children had normalization of their OAHI on the basis of currently accepted criteria
(ie, OAHI 1 per hour of TST) Pediatrics 2008;122:e149–e155

• No differences in the responses to treatment either
for
– Obese versus nonobese children or
– among children who had a history of allergic
symptoms as compared with those who did not
report any allergic problems


18

no significant changes emerged during this follow-up period in PSG
characteristics, degree of respiratory disturbance, or adenoid size

• Intranasal budesonide administered during a
period of 6 weeks to children with mild OSA
effectively alleviated severity of respiratory
disturbance, reduced size of adenoid tissues, and
significantly improved, albeit slightly, some
components of sleep architecture

• discontinuation of the therapy for a period of 8
weeks did not seem to be associated with
worsening of sleep or respiratory parameters


study design Partici- Rx control duration outcome
pant
Berlucchi RCT , AH 60 1st ST: MF 1x1 1st ST: 1st stage: 40 Reduce in clinical
2007 2 stage (3-7 yr) 2nd ST: MF placebo days symptom score and
daily 2 wks/mo 2nd ST: MF 2nd stage: 3 adenoid size
alternate months
days 2
wk/mo
Yong Gi Prospec- SDB 41 MF 1x2 no 4 wk improve SDB,
Jung tive (2-11 yr) physical symptom,
2001 adenoid size

Renaldo Prospec- AH 51 1st ST : NSS+Env. no 4wk Reduce nasal
2012 tive (4-8 yr) 2nd ST : MF 1x1 4 wk symptom score and
adenoid size

Demirhan RCT AH 45 FP drop 400 NSS 8 wk Reduce nasal
2010 (4-16 yr) mcg/day obstruction, snoring,
apnea, adenoid size
Gozal RCT, Mild OSAS 62 BD 1x1 NSS 6 wk Improve respiratory
2008 crossover (6-12yr) disturbance, reduce
adenoid size

Otolaryngology -- Head and Neck Surgery 2009 140: 139

Conclusion
• The available evidence suggests that nasal steroids may
significantly improve symptoms of nasal obstruction in children
with adenoid hypertrophy
• The effect of nasal steroids on adenoid hypertrophy appears to
be a group effect, not specific to any particular steroid
(MF,FP,BD,Beclo,flunisolide) (TA,FF??)
• Nasal steroids appear to be safe and well tolerated in children 
nonsurgical management option attractive
• more robust high-quality randomized controlled studies are
needed to confirm the results
• focus on optimal duration of treatment, minimum effective
dosage, long-term efficacy, and the safety of long-term
maintenance therapy

Areas for Future Research
• What is the optimal duration of intranasal steroid use?
• All trials have been short-term with a short-term follow-up
• Does the OSAS recur on discontinuation of therapy?
• What is the efficacy of intranasal steroids in children who
have chronic or atopic rhinitis?
• How do the benefits and adverse effects of long-term nasal
steroids compare with surgery?
• Do they correlate with clinical outcomes or long-term
prognosis?

Intranasal steroids in adenoid hypertrophy and sleep disordered breathing in children

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Intranasal steroids in adenoid hypertrophy and sleep disordered breathing in children

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