Asthma Control: Guideline Asthma Control: Guideline BasedBased

American Thoracic Society (ATS), American Thoracic Society (ATS), National Asthma Education and Prevention National Asthma Education and Prevention

Program (NAEPP), and Global Initiative for Asthma Program (NAEPP), and Global Initiative for Asthma (GINA)(GINA)

Michael P. Pietila, MDMichael P. Pietila, MDPulmonary, Critical Care and Internal Pulmonary, Critical Care and Internal Medicine Yankton Medical Clinic, P.C.Medicine Yankton Medical Clinic, P.C.Assistant Professor Sanford School of Assistant Professor Sanford School of

Medicine at USDMedicine at USD

Professional RelationshipsProfessional Relationships

I am a contracted speaker for:I am a contracted speaker for:– Merck PharmaceuticalsMerck Pharmaceuticals– Dey Pharma L.P. Bureau of COPD Research Dey Pharma L.P. Bureau of COPD Research

and Education to Advance Therapeutic and Education to Advance Therapeutic Excellence (BREATHE)Excellence (BREATHE)

I will not be speaking specifically about I will not be speaking specifically about any of these companies products today.any of these companies products today.

Defining and Recognizing AsthmaDefining and Recognizing Asthma

Netter’s Anatomy

Asthma EpidemiologyAsthma Epidemiology

Estimated > 23 million AmericansEstimated > 23 million Americans– Prevalence 5-25% of populationPrevalence 5-25% of population

Increasing prevalence and severityIncreasing prevalence and severity– USA and worldwideUSA and worldwide– Socioeconomics > geneticsSocioeconomics > genetics

$14 Billion direct annual costs in USA$14 Billion direct annual costs in USA

EpidemiologyEpidemiologyMore common in males (equal after age 20).More common in males (equal after age 20).

Atopy – Skin test reactivity, elevated IgE Atopy – Skin test reactivity, elevated IgE levels, blood eosinophilia.levels, blood eosinophilia.

Indoor allergens – dust mites, animal dander.Indoor allergens – dust mites, animal dander.

Environmental pollution, occupational Environmental pollution, occupational exposure.exposure.

Respiratory infections.Respiratory infections.

TOBACCO SMOKE.TOBACCO SMOKE.

Increasing Asthma MortalityIncreasing Asthma Mortality

500,000 hospitalizations per year in U.S.500,000 hospitalizations per year in U.S.

5-6,000 deaths per year 5-6,000 deaths per year

1978 - beginning of increasing mortality1978 - beginning of increasing mortality

Role of poverty (vs. race)Role of poverty (vs. race)– Access to health care, medications, educationAccess to health care, medications, education– Greater environmental exposureGreater environmental exposure– Importance of identifying persons with high risk of Importance of identifying persons with high risk of

deathdeath

Definition of AsthmaDefinition of Asthma

• Obstructive lung disease with characteristics Obstructive lung disease with characteristics of:of:– Airway obstruction;Airway obstruction; reversiblereversible in most patients in most patients– Chronic airwayChronic airway inflammation (eosinophils)inflammation (eosinophils)

– Increased Increased airwayairway responsivenessresponsiveness

Onset of symptoms can occur at any ageOnset of symptoms can occur at any age

NAEP - Guidelines for the Diagnosis and Management of Asthma 1991NAEP - Guidelines for the Diagnosis and Management of Asthma 1991

Guidelines for the Diagnosis and Management of Guidelines for the Diagnosis and Management of AsthmaAsthma

Key MessagesKey Messages

Asthma is an inflammatory diseaseAsthma is an inflammatory disease

Environmental factors are importantEnvironmental factors are important

Objective measures are neededObjective measures are needed

Health education is crucialHealth education is crucial

Emphasis on recognition and avoidance of triggersEmphasis on recognition and avoidance of triggers

Buist & Vollmer. NEJM 331:1584-5;1996Buist & Vollmer. NEJM 331:1584-5;1996

Asthma Guidelines 2007Asthma Guidelines 2007

Asthma Guidelines 2007Asthma Guidelines 2007

Components of severity:Components of severity:– Symptoms and objective testing.Symptoms and objective testing.– FEV1 and FEV1/FVC measurement.FEV1 and FEV1/FVC measurement.– Need for short-acting beta-agonist (SABA).Need for short-acting beta-agonist (SABA).– Nighttime awakenings.Nighttime awakenings.– Interference with normal activity.Interference with normal activity.

Diagnosing AsthmaDiagnosing Asthma

Symptoms and Medical HistorySymptoms and Medical History– Wheezing, cough, difficult breathing and chest Wheezing, cough, difficult breathing and chest

tightnesstightness

Symptoms worse at night/on awakeningSymptoms worse at night/on awakeningSeasonal patternSeasonal patternEczema, hay fever, family historyEczema, hay fever, family historyTriggers – animal fur, chemicals, temperature Triggers – animal fur, chemicals, temperature change, dust mites, drugs, exercise, pollen, URI, change, dust mites, drugs, exercise, pollen, URI, smokesmokeSymptoms respond to anti-asthma therapySymptoms respond to anti-asthma therapyColds “go to the chest” or last > 10 days.Colds “go to the chest” or last > 10 days.

Pocket Guide for Asthma Management and Prevention 2011

Asthma PhenotypesAsthma Phenotypes

Intermittent/PersistentIntermittent/Persistent– Mild/Moderate/SevereMild/Moderate/Severe

Adult onset wheezingAdult onset wheezing– Primary asthma and secondary causesPrimary asthma and secondary causes– Tends to me more severeTends to me more severe

Occupational asthmaOccupational asthma

Neutrophilic inflammationNeutrophilic inflammation

Diagnostic TestsDiagnostic Tests

No single test can secure a diagnosis of No single test can secure a diagnosis of asthmaasthma

Spirometry is the most helpful, preferred Spirometry is the most helpful, preferred method for establishing diagnosis.method for establishing diagnosis.– Increase in FEV1 of > 12% and 200 ml after Increase in FEV1 of > 12% and 200 ml after

inhaled bronchodilator.inhaled bronchodilator.– Many asthma patients are negative and Many asthma patients are negative and

repeat testing is advised.repeat testing is advised.

Diagnostic TestingDiagnostic Testing

Peak expiratory flow (PEF) – aid in Peak expiratory flow (PEF) – aid in diagnosis and management.diagnosis and management.– Compare to patient's previous best effortCompare to patient's previous best effort– 60 L/min improvement after BD or diurnal 60 L/min improvement after BD or diurnal

variation in PEF of more than 20%variation in PEF of more than 20%

Bronchoprovaction testing.Bronchoprovaction testing.– Methacholine, histamine or inhaled mannitolMethacholine, histamine or inhaled mannitol

Skin testing or specific IgE testing for Skin testing or specific IgE testing for allergens.allergens.

Diagnostic ChallengesDiagnostic Challenges

Cough variant asthmaCough variant asthma– Chronic cough, often at nightChronic cough, often at night

Exercise induced bronchospasmExercise induced bronchospasm– Exercise challengeExercise challenge

Asthma in the elderlyAsthma in the elderly– COPD vs asthmaCOPD vs asthma

Occupational asthmaOccupational asthma– Must correlate symptoms with occupationMust correlate symptoms with occupation

Goals of TherapyGoals of Therapy

Avoid troublesome symptoms night and Avoid troublesome symptoms night and dayday

Use little or no reliever medsUse little or no reliever meds

Have productive and physically active lifeHave productive and physically active life

Have (near) normal lung functionHave (near) normal lung function

Avoid serious attacksAvoid serious attacks

Initiating TherapyInitiating Therapy

Determine level of severity.Determine level of severity.Consider interval since last exacerbation.Consider interval since last exacerbation.– Fluctuations in severity and frequency may occur.Fluctuations in severity and frequency may occur.

Risk assessment:Risk assessment:– Exacerbations requiring oral corticosteroids:Exacerbations requiring oral corticosteroids:

0-1 per year in intermittent (low risk) patient.0-1 per year in intermittent (low risk) patient.> or equal to 2 per year in persistent (higher risk) patient.> or equal to 2 per year in persistent (higher risk) patient.

Keep in mind the patients baseline FEV1.Keep in mind the patients baseline FEV1.Initiate treatment in a stepwise fashion.Initiate treatment in a stepwise fashion.– Reevaluate level of control in 2-6 weeks.Reevaluate level of control in 2-6 weeks.

Asthma CareAsthma Care

Patient/doctor relationshipPatient/doctor relationship– Avoid triggers, understand and take meds, recognize Avoid triggers, understand and take meds, recognize

symptoms and seek advice in timely fashionsymptoms and seek advice in timely fashion

Identify and reduce exposure to riskIdentify and reduce exposure to risk– Smoke, drugs, dust, fur, pollens, moldSmoke, drugs, dust, fur, pollens, mold

Assess, treat and monitorAssess, treat and monitor– Stepwise approach, Ongoing monitoring q 3 monthly Stepwise approach, Ongoing monitoring q 3 monthly

when stable, within 2 weeks after exacerbation.when stable, within 2 weeks after exacerbation.

Manage exacerbationsManage exacerbations

Stepwise ApproachStepwise Approach

If disease is poorly controlledIf disease is poorly controlled– First evaluate for adherence to treatments and First evaluate for adherence to treatments and

avoidance of triggersavoidance of triggers– Consider a step up treatmentsConsider a step up treatments

If disease is well controlledIf disease is well controlled– Step down treatmentsStep down treatments

Medications must be adjusted based on Medications must be adjusted based on response to treatment and control of underlying response to treatment and control of underlying disease, not on a fixed timetable.disease, not on a fixed timetable.– If a medicine is not effective after 3 months, it should If a medicine is not effective after 3 months, it should

be stoppedbe stopped

Inhaler TechniqueInhaler Technique

Moderate to Severe Persistent Moderate to Severe Persistent AsthmaAsthma

Daytime symptoms daily and nighttime Daytime symptoms daily and nighttime symptoms at least weekly.symptoms at least weekly.

Using their rescue inhaler at least once Using their rescue inhaler at least once daily.daily.

FEV1 < 80% of predicted.FEV1 < 80% of predicted.

FEV1/FVC ratio reduced by 5% from FEV1/FVC ratio reduced by 5% from baseline.baseline.

Moderate to Severe Persistent Moderate to Severe Persistent AsthmaAsthma

Moderate to High dose Inhaled Moderate to High dose Inhaled Corticosteroids (ICS) are the cornerstone Corticosteroids (ICS) are the cornerstone of treatment.of treatment.– Higher potency preparations require fewer Higher potency preparations require fewer

puffs and encourage compliancepuffs and encourage compliance– Under dosing of ICS will result in poorer Under dosing of ICS will result in poorer

controlcontrol

Managing DiseaseManaging Disease

Add in a Long Acting Beta Agonist (LABA)Add in a Long Acting Beta Agonist (LABA)– Most pts in the severe category require at least 2 controller Most pts in the severe category require at least 2 controller

agentsagents– Should NEVER be used as monotherapyShould NEVER be used as monotherapy

Leukotriene antagonists are also an option:Leukotriene antagonists are also an option:– Limited evidence in literatureLimited evidence in literature– Montelukast, Zafirlukast, ZiluetonMontelukast, Zafirlukast, Zilueton

TheophyllineTheophylline– Limited role, controller agent only, not as efficacious as LABA’sLimited role, controller agent only, not as efficacious as LABA’s

If symptoms are severe add oral corticosteroids.If symptoms are severe add oral corticosteroids.– 5-7 days if normal FEV1, 14-21 days if reduced FEV15-7 days if normal FEV1, 14-21 days if reduced FEV1

Consider treatment with IgE antibody.Consider treatment with IgE antibody.

Oral GlucocorticoidsOral Glucocorticoids

Most potent and effective controller agent.Most potent and effective controller agent.– Reserve for severe disease and those with Reserve for severe disease and those with

reduced FEV1, use lowest dose possiblereduced FEV1, use lowest dose possible– Should see an improvement in FEV1 of 15% Should see an improvement in FEV1 of 15%

after 2-3 weeksafter 2-3 weeks– If requiring oral GC’s every 2-3 months If requiring oral GC’s every 2-3 months

consider daily low dose (5-10 mg)consider daily low dose (5-10 mg)

Follow-upFollow-up

4 to 8 week intervals.4 to 8 week intervals.– Use a questionnaire to evaluate controlUse a questionnaire to evaluate control

Asthma Control Test (ACT)Asthma Control Test (ACT)

– Consider spirometry if worsening symptoms Consider spirometry if worsening symptoms or a step down in careor a step down in care

http://www.asthma.com/resources/asthma-control-test.html

Xolair: What is That?Xolair: What is That?

Xolair (Omalizumab): Is an recombinant Xolair (Omalizumab): Is an recombinant monoclonal anti-IgE antibody designed to monoclonal anti-IgE antibody designed to treat moderate to severe allergy treat moderate to severe allergy associated asthma.associated asthma.– Must demonstrate sensitization to an allergen.Must demonstrate sensitization to an allergen.– Inadequate control with inhaled steroids.Inadequate control with inhaled steroids.

Asthma Guidelines 2007Asthma Guidelines 2007

Xolair therapy:Xolair therapy:– Reduce the need for systemic and inhaled Reduce the need for systemic and inhaled

glucocorticoids.glucocorticoids.– Reduce the number of exacerbations, especially Reduce the number of exacerbations, especially

severe exacerbations.severe exacerbations.– No effect on FEV1 values.No effect on FEV1 values.– Given via SubQ route q 2 to 4 weeks.Given via SubQ route q 2 to 4 weeks.– 850 patients radomized850 patients radomized

25% reduction in rate of exacerbation25% reduction in rate of exacerbationOverall response rate 30-50%Overall response rate 30-50%12 week trial should be offered12 week trial should be offered

Hanania, et al;Ann Intern Med 2011;154:573

Co-Morbid IllnessCo-Morbid Illness

Allergic rhinitis – treat with nasal GC’s if Allergic rhinitis – treat with nasal GC’s if surgical disease refer to ENTsurgical disease refer to ENT

GERD – treat with PPI if patient is GERD – treat with PPI if patient is symptomatic from GERDsymptomatic from GERD

Vocal cord dysfunction (VCD)- referral to Vocal cord dysfunction (VCD)- referral to qualified speech therapistqualified speech therapist

OSA – study in sleep lab and treat as OSA – study in sleep lab and treat as indicatedindicated

Special ConsiderationsSpecial Considerations

PregnancyPregnancy– Variable, safeVariable, safe

ObesityObesity– Weight loss helpsWeight loss helps

SurgerySurgery– PFT’s, if < 80% FEV1 PFT’s, if < 80% FEV1

steroids helpsteroids help

Chronic sinus/rhinitisChronic sinus/rhinitis– Treating these will Treating these will

improve asthmaimprove asthma

OccupationalOccupationalURI’sURI’sGERGER– More common in More common in

asthma but treatment asthma but treatment doesn’t reduce doesn’t reduce morbiditymorbidity

ASA inducedASA induced– 28%28%

AnaphylaxisAnaphylaxis

SummarySummary

Accurate and complete history and Accurate and complete history and physical is crucial.physical is crucial.

Objective testing – spirometry, Objective testing – spirometry, methacholine challenge, peak flows, methacholine challenge, peak flows, serum studies.serum studies.

Classify the patient.Classify the patient.

Step care.Step care.

Reevaluation/follow-up.Reevaluation/follow-up.

SummarySummary

Written action planWritten action planProper inhaler techniqueProper inhaler techniqueTrigger avoidanceTrigger avoidanceInhaled GC’s are cornerstone of therapyInhaled GC’s are cornerstone of therapyLABA’s should be added nextLABA’s should be added nextLTA’s or theophylline followLTA’s or theophylline followConsider IgE antibody in proper subsetConsider IgE antibody in proper subsetTreat comorbid illnessesTreat comorbid illnesses