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Figure9-1  Managementalgorithmbasedonlevelofcontrol.ICS,inhaledcorticosteroids;IL,interleukin;LABA,long-acting

β2-agonist;LAMA,long-actingmuscarinic antagonist; LTRA,leukotriene receptor antagonist;SABA,short-acting β2-agonist.

*Figurereflects recommendations foradults andadolescents aged12+years.(Copyright©2022Global Initiative forAsthma,

usedwithexpresspermission,www.ginasthma.org)

PharmacologicTherapies

Whenchoosingatreatmentregimen,thepatient’sasthmaseverityshouldbeclassifiedasdescribed above.

SHORT-ACTINGΒ2-AGONISTS

Regardlessofasthmaseverity,allpatientswithasthmashouldhaveaccesstoquick-reliefmedications used on an as-needed basis for treatment of symptoms and exacerbations (via either MDI or nebulization). Traditionally, for intermittentasthma,SABAs should be usedonan as-needed basis (e.g.,albuterol, two puffs q6h). Additionally, SABAs are considered the drug of choice for preventing exerciseinducedbronchoconstriction. AllSABAsnowusehydrofluoroalkane asa propellant.Theyshouldbeprimedwith fourpuffswhen firstusedandagainifnotusedover2weeks. The Global Initiative for Asthma (GINA) now recommends against using SABA-only treatment for mild asthmainthe GINA2019 and2020 strategy report. Thisis based on data thatseriousadverse events from asthma canoccurinthose patientswithinfrequent symptoms andthat SABA overuseis associated with risk of poor outcomes. However, the National Asthma Education and Prevention Program (NAEPP) EPR-4 update did not specifically address this issue and SABAs remain the treatmentofchoiceformildintermittentasthmaaccordingtotheNAEPP.

INHALEDCORTICOSTEROIDS

ICSinhalersaregenerallyadministeredviaadrypowderinhaler,MDIwithaspacingdevice,orcan benebulized(Table9-14).

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TABLE9-14

COMPARATIVEDAILYADULTDOSAGESFORINHALEDCORTICOSTEROIDS

Drug LowDose

(μg)

MediumDose (μg)

HighDose (μg)

BeclomethasoneHFA(40or80μg/puff) 80–240 >240–480 >480

BudesonideDPI(90,180,or200μg/dose) 180–600 >600–1200 >1200

Budesonidenebulizedrespules(250,500,or 1000μg/respules)

250–500 >500–1000 >1000

CiclesonideHFA(80or160μg/puff) 160–320 >320–640 >640

FluticasonepropionateHFA(44,110,or 220μg/puff)

88–264 >264–440 >440

Fluticasonefuroate(100,220μg/puff) 100–300 >300–500 >500

MometasonefuroateDPI(110or220μg/puff) 220 440 >440

Datafromthe2020GINAReport:GlobalStrategyforAsthmaManagementandPrevention.GlobalInitiativeforAsthma–GINA. Updated2020.AccessedFebruary24,2021.https://ginasthma.org/gina-reports/andNAEPPThirdExpertPanelonthe DiagnosisandManagementofAsthma.AccessedFebruary24,2021.https://www.jacionline.org/action/showPdf?pii=S0091-

6749%2820%2931404-4

DPI,drypowderinhaler;HFA,hydrofluoralkane;MDI,metered-doseinhaler.

Systemic corticosteroid absorption can occur in patients who use high doses of ICS. Consequently, prolongedtherapywithhigh-doseICSshouldbereservedforpatientswithseverediseaseorforthose whootherwiserequireoralcorticosteroids. PharmacologicalinhibitorsofcytochromeP450mayreducesteroideliminationinpatientsonICS,thus increasingsteroidsideeffects. AttemptsshouldbemadetodecreasethedoseofICSevery2–3monthstothelowestpossibledoseto maintaincontrol. Traditionally,patientswithmildpersistentasthmaaretreatedwithadailymaintenancelow-doseICSs that are to be taken as prescribed regardless of symptoms. Patients are further instructed to take a SABAwithsymptoms.

COMBINATIONTHERAPY

Alternative regimens in moderate persistent asthma include a maintenance low-dose ICS/LABA (or medium-doseICS)takenasamaintenanceinhalerwithaSABAusedasneeded. In addition, the treatment of moderatepersistent asthma can include a low-dose ICS/LAMA. At the momenttiotropium(Spiriva)is theonlyFDA-approvedstand-alonemuscarinic antagonistforasthma specifically. Alow-doseICSplusaleukotrienemodifier(LTM)ortheophyllinecanbeconsideredbutisgenerally lesspreferred.

REGIMENUSINGICS/FORMOTEROL

Formoterol is a LABA, but it can provide relief of symptoms quickly (similar to SABAs) due to

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formoterol’srapidonsetofactionascomparedtootherLABAs.Usingthischaracteristic,severalasneededoptionsforICS/formoterol havebeenstudiedandshownefficacy.41However,atthemoment, thesetreatmentmethodsarestilloff-labelintheUS. Low-doseICSincombinationwithformoterol usedasneededcanbeanoptionfortreatmentofmild asthmaratherthanamaintenanceICSandas-neededSABA. Single maintenance and reliever therapy(SMART)usesa low- or medium-doseICScombinedwith formoterol ona maintenancebasis andas needed for relief of asthma symptoms. SMART has been shown to reduceexacerbations and is a preferred treatment for mild or mild tomoderate persistent asthma.

LEUKOTRIENEAGENTS

Leukotrienesaremediatorsintheinflammatorycascade. LTMsincludemontelukastandzafirlukast,whichareoralleukotrienereceptorantagonists(LTRA), andzileuton,whichisanoral5-lipoxygenaseinhibitor. Thesemedicationscanbeconsideredasanalternativefirst-linemedicationformildpersistentasthma andasanadd-ontoICSformoresevereformsofasthma. In particular, these medications should be considered for patients with aspirin-sensitive asthma, exercise-inducedbronchoconstriction,concurrentallergicrhinitis,orinindividualswhocannotmaster theuseofaninhaler.

PharmacologicTherapiesinSeverePersistentAsthma

Optimal treatment of severe persistent asthma is of the utmost importance given the high degree of morbidityandmortalityinthisgroupanddeservesparticularattention. Treatment of severe persistent asthma generally involves the use of a medium-dose or high-dose ICS/LABA as a maintenance inhaler. However, use of a LAMA in the place of a LABA can be considered. In patients notcontrolled onhigh-dose ICS/LABA therapy, consideration should be givento add-on therapywithtiotropiumoranLTM. Selectedpatientswhohaveuncontrolledasthmadespitetheuseofhigh-doseICS/LABAtherapyandin whommedicationadherenceisnotanissueshouldbecarefullyconsideredforbiologictherapy. Biologic therapywith monoclonalantibodies against IgEandinterleukin(IL)-4, IL-5, andIL-13 has beenshowntobe highlyeffective incertainpatientswithseverepersistentasthmanotcontrolledon highdosesofICSpluslong-actingbronchodilators(seeTable9-15).

OmalizumabisamonoclonalantibodyagainstIgEthathasbeenshowntoreduceexacerbationrates, decrease emergency healthcare utilization, and improve asthma-related quality of life in patients with moderate to severe persistent allergic asthmawith a demonstrable sensitivityto a perennial allergenandincompletesymptomcontrolwithICS.

TABLE9-15

FDA-APPROVEDBIOLOGICSFORASTHMA

Biologic Medication

Mechanism ofAction

Indication Dosingand

Administration

Omalizumab Bindsfree ≥6yoldwithmoderatetoseverepersistent 150–375mg

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IgE asthma,anIgElevelof30–700IU/mL(US

≥12y)and30–1300IU/mL(US6–11y),and positiveIgEspecifictestsorskintestingtoa perennialallergen.

SCq2-4weeks dependingon IgElevel

Mepolizumab BindstoIL-5

ligand

≥12yold(US)or≥6yold(EU)withsevere eosinophilicasthmaunresponsivetoGINA Step4–5therapy.SerumAEC≥150–300 cells/μL.

100mgSC q4wk

Reslizumab BindstoIL-5

ligand

≥18yoldwithsevereeosinophilicasthma unresponsivetoGINAStep4–5therapy. SerumAEC≥400cells/μL.

3mg/kgIV q4wk

Benralizumab BindstoIL-5

receptorα

≥12yoldwithsevereeosinophilicasthma unresponsivetoGINAStep4–5therapy. SerumAEC≥300cells/μL.

30mgSCq4wk forfirstthree dosesfollowed by30mgq8wk

Dupilumab BindstoIL-4

receptorα; blocks signalingof IL-4andIL13

≥12yoldwithsevereeosinophilicasthma unresponsivetoGINAStep4–5therapy. SerumAEC≥150cells/μLorFeNO≥25ppb.

400–600mg SCloading doseinitially followedby 200–300mg SCq2wk

AEC, absolute eosinophil count; FeNO, fractional nitric oxide concentration in exhaled breath; GINA, Global Initiative for Asthma;IL,interleukin;IU,internationalunit.

Mepolizumab and reslizumab are humanized monoclonal antibodies against IL-5, which reduce eosinophilic inflammation and have been shown to significantly reduce the frequency of exacerbations and hospitalizations in patients with severe asthma. Mepolizumab is delivered subcutaneously(andcannowbeself-administeredathome),whilereslizumabisdeliveredbasedon weightdosingintravenously.

43,44

BenralizumabisamonoclonalantibodydirectedagainsttheαreceptorofIL-5thathasbeenshown tosignificantlydecrease exacerbations, improve lung function, andreducesystemic corticosteroid exposureinpatientswithsevere,steroid-dependentasthma.Benralizumabcanbeself-administered athomeandcarriesthebenefitofevery8weekdosing(afterthefirstthreedoses).

DupilumabisahumanmonoclonalantibodyagainsttheαreceptorofIL-4thatblockssignalingfor IL-4andIL-13.Amongpatientswithuncontrolledsevereasthma,dupilumabwasshowntodecrease therateofsevereexacerbation,improvelungfunction,andimproveasthmacontrol.Thiseffectwas mostpronouncedinpatientswithaneosinophilcount>300cells/mm3orFeNO≥25ppb.Dupilumab canbeself-administeredathomeandshouldbeadministeredevery2weeks.

ManagementofAsthmaExacerbations

Managementofanexacerbationrequiring hospital-based care should followa treatmentalgorithm to triagepatientsbasedonresponsetotreatment.

The response to initial treatment (three treatments with a short-acting bronchodilator every 20 minutesfor60–90minutes)canbeabetterpredictoroftheneedforhospitalizationthantheseverity

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ofanexacerbation. Patientsathighriskofasthma-relateddeathshouldbeadvisedtoseekmedicalattentionearlyinthe courseofanexacerbation. A low threshold foradmissionis appropriatefor patients withrecent hospitalization, a failureof aggressiveoutpatientmanagement(withoralcorticosteroids),orapreviouslife-threateningattack. During an exacerbation, reversal of airflow obstruction is achieved most effectively by frequent administrationofaninhaledSABA.

Fora mild to moderate exacerbation, initialtreatmentstartswithtwotosixpuffsofalbuterol

via MDI with a spacer or 2.5 mg via nebulizer and is repeated q20min until improvement is

obtainedortoxicityisnoted.

Forasevereexacerbation,albuterol2.5–5mgq20minwithipratropiumbromide0.5mgq20min

should be administered via nebulizer. Alternatively, albuterol 10–15 mg, administered

continuouslyoveranhour,maybemoreeffectiveinseverelyobstructedadults.Ifused,telemetry

monitoringisnecessary.

Levalbuterolfourtoeightpuffsornebulized1.25–2.5mgq20mincanbesubstitutedforalbuterol

buthasnotbeenassociatedwithfewersideeffectsinadults.

During an exacerbation, systemic corticosteroids speed the resolution of exacerbations of asthmaandshouldbeadministeredpromptlytoallpatients.

The ideal dose of corticosteroid needed to speed recovery and limit symptoms is not well

defined.A singleordivided dailydose equivalenttoprednisone40–60mgisusuallyadequate.

Oral corticosteroid administration seems to be as effective as IV administration if given in

equivalentdoses.

For maximal therapeutic response, tapering of high-dose corticosteroids should not take place

untilobjectiveevidenceofclinicalimprovementisobserved(usually36–48hoursorwhenPEF

>70%).Initially,patientsaregivenadailydoseoforalprednisone,whichisthenreducedslowly.

A 7- to 14-day tapering dose of prednisone is usually successful in combination with an ICS

instituted at the beginning of the tapering schedule. In patients with severe disease or with a

historyofrespiratoryfailure,aslowerdosereductionisappropriate.

Patientsdischargedfrom theED should receive oral corticosteroids. Adose of prednisone, 40

mg/day for 5–7 days, can be substituted for a tapering schedule in selected patients. Either

regimenshouldbeaccompaniedbytheinitiationofanICSoranincreaseinthepreviousdoseof

ICS.

For selected patients having a mild or moderate exacerbation, an alternative to oral

corticosteroidsisarecommendationthatpatientshavinganexacerbationquadrupletheirICS.

OtherAsthmaTherapies

Methylxanthines:Theophyllinehashistoricalutilityinthemanagementofasthmabutshouldbealastlineoptiongiventhewidevarietyofoptionswithlesstoxicity. IVmagnesiumsulfate:Duringasevereexacerbationrefractorytostandardtreatmentover1hour,one doseof2gIVover20minutesintheEDshouldbeconsidered.Ithasbeenshowntoacutelyimprove lungfunctionespeciallyinthosewithsevere,life-threateningexacerbations. Inhaled heliox: During a severe exacerbation refractory to standard treatment over 1 hour, helioxdrivenalbuterolnebulizationinamixturewithoxygen(70:30)shouldbeconsidered.Ithasbeenshown toacutelyimprovelungfunction,especiallyinthosewithsevere,life-threateningexacerbations.

Macrolides: Antibiotics have not been shown to have any benefit when used to treat asthma exacerbations. Although results are conflicting across trials, chronic azithromycin therapy can be

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considered in patients with severe persistent asthma who are poorly controlled despite maximal therapy. SC allergen immunotherapy (SCIT) can be considered in allergic patients with mild to moderate disease with persistent symptoms despiteadherence toallergenavoidance andmedications. SCITis relativelycontraindicatedinpatientswithsevereorunstableasthma(chronicoralcorticosteroiduseor severeexacerbationsrequiringhospitalizationorintubationintheprevious6months). Bronchial thermoplasty: Bronchial thermoplasty is a novel therapy for severe asthma in which a specializedradiofrequencycatheterisintroducedthroughabronchoscopetodeliverthermalenergyto smallerairwaystoreducesmoothmusclemasssurroundingtheairways.Bronchialthermoplastyshould be only performed in veryselected patientsbyexperienced bronchoscopists inconjunction with an asthmaspecialist,andideallyaspartofaclinicalregistry.

OxygenationandMechanicalVentilation

Supplementaloxygenshouldbeadministeredtothepatientwhoisawaitinganassessmentofarterial oxygentensionandshouldbecontinuedtomaintainanoxygensaturation>92%(95%inpatientswith coexistingcardiacdiseaseorpregnancy). Mechanicalventilationmayberequiredforrespiratoryfailure.

General principles include use of a large endotracheal tube (≥7.5 mm), prolonged expiratory

timewithhighinspiratoryflows,andlowrespiratoryrate.PEEPshouldbepatienttargetedand mayneedtobeupwardlyadjustedinsomecasestoavoiddevelopmentofintrinsicPEEP.

Ketamineand propofol mayprovide modest bronchodilatoryeffects in addition to sedation. After deep sedation, paralytics may have an advantage in decreasing muscular tone and minimizing patient–ventilatordyssynchrony. RecenttrialshaveshownthatNIVmaybecarefullyusedinpatientswithacuteasthmaexacerbations anddecreasestheriskofendotrachealintubation.48Dataonasurvival benefitinusingNIV inthis groupareconflicting. Although prospective data are lacking, extracorporeal life support may be beneficial in cases of severeventilatoryfailureassociatedwithasthmaexacerbationsinpatientswhoaredeterioratingon mechanicalventilation.

Lifestyle/RiskModification

DIET

Thereisnogeneraldietthatisknowntoimproveasthmacontrol.However,asmallpercentageofpatients mayhavereproducibledeteriorationafterexposuretodietarysulfitesusedtopreventdiscolorationin foodssuchasbeer,wine,processedpotatoes,anddriedfruit.Thesefoodsshouldbeavoidedinpatients iftheyhavehadpriorreactionstothem.

ACTIVITY

Patientsshouldbeencouragedtoleadanactivelifestyle.Ifasthmaiswellcontrolled,patientsshould expecttobeasphysicallyactiveastheydesire.Ifexerciseisatrigger,patientsshouldbeadvisedto continuephysicalactivityafterprophylacticuseofanLTM(montelukast10mg2hoursbeforeexercise) oraninhaledβ2-agonist(twotofourpuffs15–20minutesbeforeexposure).

SPECIALCONSIDERATIONS

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Duringpregnancy,patientsshouldhavemorefrequentfollow-upbecausetheseverityofasthmaoften changesandrequiresmedicationadjustment.Thereismorepotentialrisktothefetuswithpoorly

controlledasthmathanwithexposuretoasthmamedications,mostofwhicharegenerally consideredsafe.

Occupationalasthmarequiresadetailedhistoryofoccupationalexposuretoasensitizingagent,lackof asthmasymptomsbeforeexposure,andadocumentedrelationshipwithsymptomsandtheworkplace. Beyondstandardasthmamedicaltreatment,exposureavoidanceiscrucial. AERD: Patients with aspirin sensitivity and chronic rhinosinusitis with nasal polyps typically have onset of asthma in the third or fourth decade of life. Aspirin desensitization may be considered in patientswithcorticosteroid-dependentasthmaorthoserequiringdailyaspirin/NSAIDtherapyforother medicalconditions.

Complications

MedicationSideEffects

SABA: Sympathomimetic symptoms (tremor, anxiety,tachycardia), decrease in serumpotassium and magnesium,mildlacticacidosis,prolongedQTc.

ICS

Increased risk for systemic effects at high doses (equivalent >1000 μg/day of beclomethasone) includingskinbruising,cataracts,elevatedintraocularpressure,andacceleratedlossofbonemass. Pharyngeal and laryngeal effects are common, such as sore throat, hoarse voice, and oral candidiasis. Patients should be instructed to rinse their mouth after each administration to reducethe possibilityofthrush. Achangeinthedeliverymethod and/oruse ofa valved holding chamber/spacermayalleviatetheothersideeffects.

LABA

Fewersympathomimetic-typesideeffects. Associated withan increased riskof severe asthma exacerbations and asthma-related deathwhen usedwithoutICSbasedontheSalmeterolMulticenterAsthmaResearchTrial,whichshowedavery low but significant increase in asthma-related deaths in patients receiving salmeterol (0.01%–

0.04%).

Should only be used in combination with ICS. FDA recommends discontinuation of LABA once asthmacontrolisachievedandmaintained.

LTM

Cases of newly diagnosed eosinophilic granulomatosis with polyangiitis (Churg-Strauss) after exposuretoLTRAhavebeendescribed,butitisunclearwhethertheyarerelatedtounmaskingofa preexistingcasewithconcurrentcorticosteroidtaperingorwhetherthereisacausalrelationship. Zileutoncancauseareversiblehepatitis,soitisrecommendedthathepaticfunctionbemonitoredat initiation once a month during the first 3 months, every 3 months for the first year, and then periodically.

Biologictherapy:Allbiologictherapiesposethe riskofimmunogenicity,hypersensitivity,or,rarely, anaphylaxis.Todaymostbiologictherapiescansafelybeadministeredathome.

Methylxanthines

Theophylline has a narrow therapeutic range with significant toxicities, such as arrhythmias and seizures,aswellasmanypotentialdruginteractions,especiallywithantibiotics. Serumconcentrationsoftheophyllineshouldbemonitoredonaregularbasis,aimingforapeaklevel of5–10μg/mL;however,atthelowerdosesusedforasthma,toxicityismuchlesslikely.

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Referral

Referraltoaspecialistshouldbeconsideredinthefollowingsituations:

Patients who require step 4 (see Figure 9-1) or higher treatment, or patients who have had a life- threateningasthmaexacerbation. Patientsbeingconsideredforbiologictherapy,bronchialthermoplasty,orotheralternativetreatments. Patientswithatypicalsignsorsymptomsthatmakethediagnosisuncertain. Patients withcomorbidities such as chronic sinusitis, nasal polyposis, ABPA, VCD, severe GERD, severerhinitis,orsignificantpsychiatricorpsychosocialdifficultiesinterferingwithtreatment. Patients requiring additional diagnostic testing, such as rhinoscopy or bronchoscopy, bronchoprovocationtesting,orallergyskintesting. Patientswhoneedtobeevaluatedforallergenimmunotherapy.

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