Tratamentul Inhalator Al Astmului Bronsic La Copil

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    Nat i o n a l In st i t u t e f o r

    Cl i n i ca l Excel l en ce

    90 Lon g Acre

    Covent Ga rden

    London

    WC2E 9RZ

    We b : w w w . n ice .o rg . uk

    22197 1P 45k Sept 00 (ABA)

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    Guidance on

    t he use of

    inhaler syst ems

    (dev ices) in

    chi ld ren under

    t he age of 5

    years w i t h

    chron ic ast hma

    Augu st 2000

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    This Guidance is written in the following context:

    This guid an ce represent s the view of t he Institut e's Appraisal

    Committee, the membership of which is set out in Appendix A,

    w hich w as arrived at af ter careful considerat ion o f t he a vailab le

    evidence. Health professionals are expected to take it fully into

    a ccoun t w hen e xercising th eir clinica l judg ement a bo ut th e use of

    inhaler systems (devices) in children unde r th e a g e of 5 years w ith

    chronic a sthm a . This g uidan ce d oes not , how ever, override the

    individual responsibility of health professionals to make

    a ppropriate decisions in the circumstances of the individual

    patient, in consulta tion w ith the pa tient a nd/or g uardian o r carer.

    National Institute for

    Clinical Excellence

    90 Lo ng Acre

    Covent Ga rden

    London

    WC2E 9RZ

    We b: w w w . nice .o rg .uk

    ISBN: 1-84257-033-1

    Published by t he Nat iona l Institut e fo r Clinica l Excellence Aug ust 2000

    Copyright Na tion al Institute fo r Clinica l Excellence 2000. All right s reserved.

    This mat erial ma y be freely reproduced f or educat ional an d no t fo r profit

    purposes w ithin the NHS. No reproduction b y or f or commercial orga nisat ions is

    permitted w ithout the e xpress w ritt en permission of the Institute.

    This document has been circulated to the following:

    Hea lth Authorit y Ch ie f Execu t ives in Eng la nd a nd Wa les

    NHS Trust Chief Execut ives in England and Wales

    PCG Ch ie f Exe cut ive s

    Lo ca l He a lt h G ro u p G e ne ra l M a na g e rs

    M ed ica l a nd Nursing D ir ecto r s in Eng la nd a nd Wa les

    He a lt h pro f essio n a ls w o r kin g w it h a st h ma

    G Ps in Eng la nd a nd Wa les

    NHS Direct or Wa les

    Ch ie f Exe cu t ive o f t he NHS in En g la n d

    NHS Exe cu t ive Re g io n a l D ire ct o rs

    Specia l Hea lth Authorit y Ch ie f Execu t ives

    Co m m un it y He a lt h Co u ncils in En g la n d a n d Wa le s

    Pa tient a dvo ca cy gro ups

    Co m missio n fo r He a lt h Im pro ve me nt

    NHS Clin ica l G o ve rn a n ce Su pp o rt Te a m

    Chie f M edica l a nd Nursing O f f icers in Eng l a nd a nd Wa les

    Medica l Director &Head of NHS Quality Na t iona l Assembly

    fo r Wales

    Clin ica l Ef f ect iveness Suppor t Un it - Wa les

    Represen ta t ive b od ies f o r hea l th services, p ro f essiona l

    orga nisat ions and sta tuto ry bodies, Royal Colleg es

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    1. Guidance

    1.1 For children under the age of 5 years with chronic stable asthma bothc o rt i c o s t e roids and bronchodilator therapy should be ro u t i n e l ydelivered by pressurised metered dose inhaler (pMDI) and spacersystem, with a facemask where necessary.

    1.2 Where this combination is not clinically effective for the child anddepending on the childs condition, nebulised therapy may beconsidered and in the case of children aged 3 to 5 years, a dry powderinhaler (DPI) may also be considered.

    1.3 Choice of device to be made within the pMDI and spacer range shouldbe primarily governed by specific individual need and the likelihood ofgood compliance. Once these factors have been taken into account,choice should be made on the basis of cost minimisation.

    Guidance on the

    use of inhaler

    systems (devices)

    in children under

    the age of 5

    years with

    chronic asthma

    Technology Appraisal

    Guidance No. 10Issue Date August 2000Review Date August 2003

    This section, Section 1, constitute s the Institutes Guida nce on th e use o f inha ler

    systems (devices) in children un der th e a ge of 5 years with chronic asthm a. The

    remainder of the d ocument is structured in the follow ing w ay:

    2 Clin ica l Need a nd P ra c t ice

    3 Th e Te ch no lo g y

    4 Evidence

    5 Implica t ions f o r the NHS

    6 Re la t ed Guid a nce

    7 Fu rt h e r Re se a rch

    8 Im ple me nt a tio n

    9 Clinica l Audit Advice

    10 Review o f Gu id a nce

    Appendix A: Appraisal Committ ee

    Appendix B: Sources of Evidence

    Appendix C: Informat ion for

    Patients.

    The full document and a Summary of Evidence are a vailab le from our w ebsite a t

    w w w .nice.org.uk or by telepho ning 0541 555 455 a nd q uot ing t he reference n umber 22197.

    Maer adran ho n (adran 1) hefyd ar g ael yn Gymraeg ar e in gw efan neu drwy g ysyll tu

    0541 555 455, rhif cyfe irnod 22198.

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    2.1 Asthma is a common disease that produces symptoms ofwheezing and breathlessness. It affects the lower airways andresults in narrowing (bronchoconstriction) of the airways withconsequent reduction in the flow of gases between the airwaysand lung alveoli. It can be triggered by a variety of

    environmental factors such as infection, allergy, airbornechemicals and also exercise. There are a number of patterns oflower airways disease in early childhood that results in twopredominant clinical patterns (acute wheezy episodes andrecurrent day to day symptoms) that may occur separately ortogether in the child.

    2.2 The overall prevalence of asthma in England and Wales isaround 8% to 10% although not all cases are currently beingtreated. In all children under the age of 5 years about 9% ofboys and 6% of girls are prescribed inhalers. There is a strong

    genetic component in the aetiology of this disease. There is alsowide geographical variation in prevalence, with asthma beingmore common in, for example, urban rather than ruralcommunities. It has a wide range of severity, is the cause ofconsiderable morbidity and a rare cause of death.

    2.3 The primary objective of asthma treatment is to achieveoptimal control of the disease by reducing exacerbations,increasing lung function and limiting symptoms in order tomaximise the quality of life of the child. This is currently besta c h i e ved by delivering both symptom re l i e v i n g(bronchodilators including 2 agonists and anticholinergics)

    and pre ve n t i ve anti-inflammatory drugs (typicallycorticosteroids) by inhalation. In the UK, asthma treatment isstrongly influenced by the 1997 guidelines of the BritishThoracic Society (BTS), which promote step-wisemanagement of increasingly severe asthma. The 1997 BTSguidelines are mainly based on a consensus of expert opinion.

    2.4 The estimated annual drug cost for asthma to the NHS inEngland and Wales in all age groups is approximately 115million. In children under the age of 5 years this cost is about8 million.

    3.1 It is important to ensure that an inhaler device delivers thedrugs to the airways consistently and in the appropriatequantity. There are a variety of inhaler devices that can be usedin the management of asthma: hand held inhalers i.e.pressurised metered dose inhalers (pMDIs) (which can bebreath activated or manual) and dry-powder inhalation systems(DPIs) and nebulisers. All the metered dose inhaler systemsrequire co-ordination of activation and inhalation and may bedifficult to use, particularly for younger children. For thisreason a pMDI should be combined with a spacer device inyoung children. The purpose of the spacer device is to act as anintermediary chamber into which the pMDI can discharge thedrug allowing the child to inhale over several breaths.

    The Technology

    3

    Clinical Needand Practice

    2

    2 NICE Techno logy Appraisal Gu idance No.10

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    NICE Techno logy Appraisal Gu idance No.10 3

    3.2 The inhalation devices have different mechanicalcharacteristics which, combined with child and carer factors,leads to variation in both the quantity of drug delivered by thedevice and the amount actually deposited in the lung. Usingthe appropriate inhalation device is important to ensure

    reproducibility and consistency of drug dosing, as well ascompliance for which child and carer acceptability andeducation regarding device usage may also be major factors.

    3.3 The 1997 BTS Guidelines recommend the following devicechoices for children of under 5 years of age:

    3.4 Interpretation of the evidence base for effectiveness of inhalerdevices is influenced by a number of potential factors thedrug being delivered by the device, the severity of asthma,

    whether the condition is acute or chronic and the ability of thechild/carer to effectively use the device. Moreover it is notpossible to directly extrapolate to children under the age of fiveyears, data collected in older children and adults, as the youngchild's anatomy and physiology may substantially alter theamount of drug delivered.

    4.1 Delivery of corticosteriods by a hand held deviceThe evidence base for pressurised metered dose inhalers(pMDIs) plus spacer versus dry-powder inhalation systems(DPI) for the delivery of corticosteriods in children with

    chronic asthma is relatively small and of poor quality. Tworandomised controlled trials were identified, which recruitedchildren of 5 years or under.These trials involved a total of 140children, although the majority of these recruited children of 5years or older. One of these trials was inadequately poweredand compared a pMDI alone (not recommended by currentBTS guidelines) versus DPI. The second and largest trialdemonstrated no difference in steroid delivery via a pMDI plusspacer compared to DPI (at half MDI dosage).

    Evidence

    4

    A ge 1 st Ch oi ce 2 nd Ch oi ce 3 rd Ch oi ce Br ea th - D ry -

    Group Device Device Device act uat ed pow der

    0-2 years M DI + spacer M DI + spacer Nebuliser Avo id Avoid

    inclusive + face m ask (rarely needed)

    3 -5 years M D I + sp acer M D I + sp acer N eb ul iser N ot p ro ven Po ssi ble u se

    inclusive + face m ask (rarely needed) for 2-agonist

    but not

    recommended

    for

    corticosteroids

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    4 NICE Techno logy Appraisal Gu idance No.10

    4.2 Delivery of 2 agonists by a hand held deviceThe evidence base for pressurised metered dose inhalers(pMDIs) alone or pMDI plus spacer compared to dry-powderinhalation systems (DPI) in children with chronic asthma ispoor. Four randomised controlled trials were identified that

    recruited children of 5 years or less. These trials involved a totalof 278 children, some of which were aged 5 years or more. Theremaining three studies demonstrated no difference whencomparing 2 agonist delivery via pMDI plus spacer with 2agonist delivery by DPI.

    4.3 Delivery of 2 agonists or anticholinergics by nebuliserThe evidence for nebulised bronchodilators compared withbronchodilator delivery via hand held device in children withchronic asthma is also poor.Three randomised controlled trialswhich recruited children aged 5 years or less, were identified.These trials were small and involved a total of 51 children,although many of the children were aged 5 years or older. Nodifferences were found between nebulisation, pMDIs or drypowder devices. These trials are likely to be of insufficient sizeto detect small differences between devices.

    4.4 Cost EffectivenessThere is currently a wide range in the cost of drug/inhalercombinations. No cost effectiveness studies were identified thatmake direct comparison between asthma devices in childrenunder the age of 5 years with chronic asthma.

    4.5 The documentation and opinion available to the AppraisalCommittee is set out in Appendix B.

    5.1 Where the 1997 BTS guidelines are currently being applied inpractice, the guidance is unlikely to result in substantial changein NHS costs. The impact of referral patterns is difficult topredict. It is likely however to strengthen and improve thequality of primary care based asthma therapy, thereby reducingthe need for admission or outpatient referral.

    6.1 At present there is insufficient evidence regarding the most

    clinically and cost effective spacer (e.g. small or large volume).This is reflected in the current lack of standardisation andvariations in the usage of these devices. Further research in thisarea should be carried out in relation to optimising thereproducibility, consistency and acceptability of these deliverysystems as well as their overall clinical and cost effectiveness.

    6.2 Well conducted community based trials in the management ofasthma in young children and studies to investigate factorsdetermining compliance (including health education and theacceptability of devices) in this group of children wouldenhance the future evidence base.

    Implications fort he NHS

    5

    Furt her Research

    6

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    NICE Techno logy Appraisal Guidance No.10 5

    7.1 Clinicians should review their current clinical practice for themanagement of chronic asthma in children under the age of 5years against the guidance set out in section 1.

    7.2 Relevant clinical guidelines and protocols should be reviewed

    in light of this guidance and revised if necessary.

    7.3 The appropriate selection of inhaler devices as described in thisguidance, is only one aspect for the provision of acomprehensive holistic approach to all aspects of asthmamanagement. In particular, parents/carers need education,su p po rt and guidance, on how to manage their child'scondition. General practitioners, the practice nurse, thespecialist asthma nurse, the health visitor and school nurse andother community health carers have an essential role in theprovision of this service and advice on general managementmay result in additional improvements in clinical and costeffectiveness.

    7.4 The Montreal Protocol has mandated that CFC propellantshould be phased out, and in the UK, the transition to CFC-free propellants is currently under way. The majority ofevidence reviewed (see paragraph 4) on the use of devices isbased on the use of corticosteroids and bronchodilators withCFC propellants. CFC-free propellants may interact withspacers differently to CFC-propellants, and can therefore affectthe dose of drug delivered by the spacer. In addition, not allspacers are compatible with all pressurised metered dose

    inhalers (pMDIs). The choice of spacer for the chosen pMDIshould therefore be guided by the information in the Summaryof the Product Characteristics.

    7.5 The dosage of drug delivered may vary considerably accordingto the static charge on spacer devices. It therefore advised thatspacers be washed in a household detergent and allowed to airdry. I f there are concerns about the possibility of contactdermatitis using this method, the mouthpiece of facemaskshould be rinsed in water and dried.

    8.1 To enable clinicians to audit their own compliance with thisguidance it is recommended that, if not already in place,management plans are recorded for each child with chronicasthma. These plans should re c o rd the type of devicesprescribed.

    8.2 This information should be incorporated into local clinicalaudit data recording systems and consideration given (if notalready in place) to the establishment of appropriate categoriesin electronic record systems.

    Implementation

    7

    Clinical Audi tAdvice

    8

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    8.3 Pro spec t i ve clinical audit programmes should rec o rd theproportion of treatments adhering to the guidance. Suchprogrammes are likely to be more effective in improvingpatient care when they form part of the organisations formalclinical governance arrangements and where they are linked to

    specific post-graduate activities.

    9.1 This advice will be reviewed in the light of new evidence inAugust 2003.

    Andrew DillonChief ExecutiveAugust 2000

    6 NICE Technology Appraisal Gu idance No.10

    Review ofGuidance

    9

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    NICE Techno logy Appraisal Guidance No.10 7

    Prof essor R. L.Akehur stDean, School of Health RelatedResearchSheffield University

    Prof essor David Barnett(Chairman)Professor of Clinical Pharmacolog yUniversity o f Leicester

    Pro fessor Sir Colin Berr yProfessor of Mo rbid Anatom ySt Bartholom ews and Royal London

    School of M edicine

    Dr Sheila BirdM RC Biostatist ics Unit, Cambridge

    Professor Martin BuxtonDirector of Health EconomicsResearch GroupBrunel University

    Professor Yvonne CarterProfessor of General Practice andPrimary Care

    St Bartholomew s and Royal LondonSchool of M edicine

    Dr Karl Claxto nLecturer in Econom icsUniversity of York

    Professor Duncan Colin-JonesProfessor of GastroenterologyUniversity of Southam pton

    M s Sarah Cow leyProfessor of Community PracticeDevelopment

    Kings College, London

    Dr Nicky CullumReader in Healt h Stud iesUniversity of York

    M r Chris EvennettChief Executi veM id-Hampshire Primary Care Group

    Ms Jean GaffinForm erly Executi ve DirectorNational Council for Hospice and

    Specialist Palliative Care Service

    APPENDIX A

    Appraisal Committee Members

    Mrs Sue GallagherChief Executiv eM erton, Sutton and Wandsw orthHealth Authority

    Dr Trevor GibbsInternational M edical OperationsDirectorGlaxo-Wellcome R&D Ltd

    M r John GoulstonDirector of FinanceThe Royal Free Hampstead NHS

    Trust

    Prof essor Phil ip HomeProfessor of Diabetes MedicineUniversity of Newcastle

    Dr Terry JohnGeneral PractitionerSt James Health Centre, London

    Dr Diane KetleyClinical Governance ProgrammeLeader

    Leicester Royal Inf irm ary

    Dr M ayur LakhaniGeneral Practit ioner, HighgateSurgery, Leicester andLecturer, University of Leicester

    Mr M MughalConsultant SurgeonChorley and South Ribble NHS Trust

    M r James Part ridgeChief ExecutiveChanging Faces

    Dr L.J. Patt ersonConsultant Physician and MedicalDirectorBurnley General Hospital

    Prof essor Phil ip Rout ledgeProfessor of Clinical Pharmacolog yUniversity of Wales

    Prof essor Andrew StevensProfessor of Public HealthUniversity of Birming ham

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    8 NICE Techno logy Appraisal Guidance No.10

    i ) Th e fo l lo w i n g do cu m en t at i onand opinion w as made availableto t he Commit t ee:

    a ) Assessmen t ReportThe eff ectiveness of inhalerdevices for young children wit hasthm a; Prepared by Payne N &Beard S, Trent Instit ute for HealthServices Research, School ofHealth & Related Research,University of Sheffield;Wright,

    Brocklebank,D & Ram F,Bradford Hospitals N HS Trust;Taylor RS, National Institut e forClinical Excellence. M arch 2000.

    b ) M anufactu rer /Sponso rsubmissions:i. A st raZen ecai i . Boehr inger Ing lhe im L td.i i i . Avent is Pharma (formerly

    Rhne-Poulenc Rorer)iv. Boehr inger Ing lheim Ltd .

    v. G la xo W el lco m ev i . 3M Heal th Care Ltd .v i i . Norton Healthcarevii i .Yamanouchi Pharma Ltd.

    c) Professiona l /specia l ist group,patient/carer group and tradeassociatio n subm issions;i . A sso ci at i on o f B ri t ish

    Health-Care Industriesi i . Br it ish M edica l Assoc ia t ionii i . Brit ish Thoracic Societyiv. Na t iona l Asthma Campa ignv. Roya l Co l lege o f Nu rsingvi. Royal College of Paediatrics

    & Child Healthvi i . Royal College of Physicians

    i i ) The fol low ing exper ts wereinvited to make submissions tothe Committee:

    a ) Dr Andrew Bush , Reader inPaediatri c Respirolo gy &Honorary Consultant PaediatricChest Physician, Royal Brompt onHospi ta l , London.

    b ) Dr C O Ca l laghan , Senio rLecturer & ConsultantPaediatrician,University of

    Leicester & Leicester RoyalInfirmary Childrens Hospital.

    APPENDIX B

    Sources of Evidence

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    NICE Technology Appraisal Guidance No.10 9

    What is ast hma?

    APPENDIX C

    Guidance on inhalers for childhood asthma patient information

    The pa tient informa tion in this appendix has been de sign ed t osuppo rt the production of your own information leaflets; youcan dow nload i t f rom our w eb site (w w w .nice.o rg .uk) w here itis ava ila ble in Eng lish a nd Welsh. A print ed version of t his te xtis a vailab le in Eng lish/Welsh or Eng lish a lone . If yo u w o uld likecopies of the printed leaflet please contact 0541 555 455, andquote the re ference nu mb er 22200 fo r t he Eng lish/Welshversion and 22199 for the English only version.

    What is NICEGuidance?

    The National Institute for Clinical Excellence (NICE) is part of the

    NHS. It produces guidance for both the NHS and patients onmedicines, medical equipment and clinical procedures and wherethey should be used.

    When the Institute evaluates these things it is called an appraisal.Each appraisal takes about 12 months to complete and involves themanufacturers of the drug or device, professional organisations andthe groups who represent patients.

    NICE was asked to look at the available evidence on inhaler devicesand provide guidance that would help the NHS decide which

    should be used for childhood asthma for children under five.

    Asthma is a common condition that affects the airways the smalltubes that carry air in and out of the lungs. It causes a narrowing ofthese airways and this makes breathing more difficult. Patients mayhave wheezy episodes and quickly become out of breath. Asthmacan be triggered by a number of factors that include infection,allergy or exercise. It is more widespread in urban than ruralcommunities.

    In children under the age of 5 years around 9 out of 100 boys and6 out of 100 of girls are currently being prescribed inhalers.

    Most asthma medication is delivered using an inhaler device. Thisensures that very small amounts of medication are delivereddirectly into the lungs. Asthma treatment aims to prevent anincrease in the severity of the disease, increase lung function andreduce the number of attacks. There are two main types of asthmamedication: relievers (usually blue) that provide relief from asthmaand preventers (brown, white, red or orange) which work over aperiod of time to help calm the inflammation of the airwaysmaking them less likely to react.

    How do i nhalerdevices helpasthma?

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    10 NICE Techno logy Appraisal Guidance No.10

    What has NICErecommendedabout the use ofinhaler devices?

    Inhalers are small devices which ensure that very small amounts ofmedication are delivered directly into the lungs. It is important toensure that an inhaler device delivers the drugs to the airwaysconsistently and in the right quantity. There are a variety of inhalerdevices that can be used in the management of asthma including:

    Pressurised Metered Dose Inhalers (pMDIs)

    Dry-Powder Inhalation systems (DPIs)

    nebulisers.

    All the Metered Dose Inhalers require the patient to be able toactivate the device and breath in at the same time. For this reasonthey may be difficult for younger children to use for this reasonthey should be combined with a spacer device in young children.The purpose of the spacer device is to act as an intermediarychamber into which the Pressurised Metered Dose Inhaler (pMDI)can deposit the drug allowing the child to inhale the drug overseveral breaths.

    NICE has recommended that for children under the age of 5 yearswho have chronic stable asthma:

    both cort i c o s t e roids and bronchodilator therapy shouldroutinely delive red by Pressurised Me t e red Dose In h a l e r(pMDI) and spacer system, with a facemask where necessary.

    where this combination is not clinically effective for the child,and depending on the childs condition, nebulised therapy maybe considered and in the case of children aged 3 to 5 years, a drypowder inhaler (DPI) may also be considered.

    the choice of which pMDI device and spacer to use should bedetermined by the specific needs of the child and how well itworks for them. Once these factors have been taken into accountthe choice should be made on the basis of reducing costs.

    Clinicians should review their current clinical practice for the

    management of chronic asthma in children under the age of 5 yearsagainst this guidance.

    The appropriate selection of inhaler devices as described is only oneaspect for the provision of a comprehensive approach to all aspectsof managing asthma. In particular, parents/carers need education,support and guidance, on how to manage their child's condition.General practitioners, the practice nurse, the specialist asthmanurse, the health visitor and school nurse and other communityhealth carers have an essential role in the provision of this serviceand advice on general management may result in additionalimprovements in clinical and cost effectiveness.

    What areinhalers?

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    NICE Techno logy Appraisal Guidance No.10 11

    Will NICE revi ewit s guidance?

    What should Ido?

    FurtherInformat ion

    If your child or a child you care for has asthma, you should discussthis guidance with a health professional at your next appointment.

    Yes. This guidance will be reviewed in August 2003.

    Further information on NICE, and the full guidance issued to theNHS is available on the NICE web site (www.nice.org.uk). It canalso be requested from 0541 555 455, quoting reference number22197.