Intranasal steroids in adenoid hypertrophy and sleep disordered breathing in children

INS use in Adenoid hypertrophy and sleep disordered breathing in

children

Suparat Sirivimonpan,MD.

23/11/2012

Introduction

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

Immunol Allergy Clin N Am 31 (2011) 545–560

Allergy 2008: 63: 1292–1300

• 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

OSAS (obstructive sleep apnea syndrome)

Pediatrics 2012;130:e714–e755

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

Otolaryngol Clin N Am 45 (2012) 1055–1069

• 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

• 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

Momethasone Furoate

Pediatrics 2007;119;e1392

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

adenoidectomyExclusion criteria : -concomitant tonsillar hypertrophy-positive history of allergy or atopy-URI within the past 2 weeks-nasal anatomic anomalies-sinonasal diseases (ex. polyposis)-craniofacial malformations -genetic diseases-neurologic disorders-cardiovascular diseases-immunodeficiency-history of epistaxis-hypersensitivity to steroids -intranasal, topical, or systemic steroid or antibiotic treatment within the past 4 weeks

Inclusion criteria (1) adenoid pad occluding 75% of nasopharynx(nasal endoscopy)(2) age between 3 and 7 years(3) symptoms consistent with AH lasting 12 months(4) no previous adenoidectomy

group A30 patients

group B30 patients

60 patients

first stage

Mometasone (50 mcg/nostril/day)

placebo 40 daysassessment

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

group A1 11 pts

MF alternate days ,first 2 weeks per

group A2 10 pts

daily MF ,first 2 weeks per

3 months

Nonresponders and placebo-treatedPatients adenoidectomy

3 patients did not complete the study1: systemic steroid (acute ethmoiditis)1 : lost to follow-up monitoring1 : dropped out

• 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 theseresults 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

• 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

Conclusion

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

group A30 patients

group B30 patients

60 patients

first stage

Mometasone (50 mcg/nostrilday)

placebo 40 daysassessment

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

group A1 11 pts

MF alternate days ,first 2 weeks per

group A2 10 pts

daily MF ,first 2 weeks per

3 months

Nonresponders and placebo-treatedPatients adenoidectomy

3 patients did not complete the study1: systemic steroid (acute ethmoiditis)1 : lost to follow-up monitoring1 : dropped out

• 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

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

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

A : surgery , no INS : 6 pts B : INS and Surgery : 3 ptsC : INS , no surgery : 12 pts

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

Group A : voluntarily suspended maintenance therapy within a few months (range: 1—3 months) after the first period of treatment

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 unchangedcompared to baseline data

• 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

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

mometasone furoate

• 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)

• 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

Limitation

• 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

Conclusion

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

• questionnaire on the symptoms nasal obstruction, snoring, rhinorrhea, sneezing and itching

• all the children : prick test for respiratory allergens, nasoendoscopy

NSS douching + environmental prophylaxis (general and specific allergens) 40

0 (absent)1 (mild)2 (moderate) 3 (severe)

symptoms questionnaire and to nasoendoscopy

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

symptoms questionnaire and to nasoendoscopy

adenoid area in relation to the nasopharyngeal area

main purpose of this study design was to minimize the interference of confusing external macro-environment factors(such as home, school, habits and exposure to allergens)

• 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

severe obstruction

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

moderate irritative nasal symptoms

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

NSS irrigation : reduction was not significantly different from before treatment

MF : significantly lower than that detected at the other twotime points

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

Conclusion

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

Fluticasone propionate

• 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

• 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

• 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

Conclusion

Budesonide

• 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%

Exclusion criteria • 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

Patients with a history of allergic rhinitis were also included

placebo spray [saline]) OD

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

19 withdraw (14 placebo ,5 budesonide)

Total 62

7 unwillingness to continue INS6 marked improvement (5/6 budesonide) 6 decided to pursue T&A (all placebo)

antihistaminic medications or immunotherapyfor 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)

• 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

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-pant

Rx control duration

outcome

Berlucchi2007

RCT ,2 stage

AH 60(3-7 yr)

1st ST: MF 1x12nd ST: MF daily 2 wks/mo

1st ST: placebo2nd ST: MF alternate days 2 wk/mo

1st stage: 40 days

2nd stage: 3 months

Reduce in clinical symptom score

and adenoid size

Yong Gi Jung 2001

Prospec-

SDB 41(2-11 yr)

MF 1x2 no 4 wk improve SDB, physical symptom,

adenoid size

Renaldo2012

Prospec-

AH 51(4-8 yr)

1st ST : NSS+Env.2nd ST : MF 1x1

no 4wk4 wk

Reduce nasal symptom score

and adenoid size

Demirhan 2010

RCT AH 45(4-16 yr)

FP drop 400 mcg/day

NSS 8 wk Reduce nasal obstruction,

snoring, apnea, adenoid size

Gozal 2008

RCT,crossov

Mild OSAS 62

(6-12yr)

BD 1x1 NSS 6 wk Improve respiratory

disturbance, reduce adenoid

Otolaryngology -- Head and Neck Surgery 2009 140: 139Otolaryngology -- Head and Neck Surgery 2009 140: 139

Otolaryngology -- Head and Neck Surgery 2009 140: 139

• 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

Conclusion

• 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?

Areas for Future Research

Thank you

Intranasal steroids in adenoid hypertrophy and sleep disordered breathing in children

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