Asthma (Chest 2012)

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STEPPING DOWN APPROACH

OF ASTHMA BRONCHIALE(GINA 2011)

C. Martin Rumende

Divisi Pulmonologi Departemen Ilmu

Penyakit Dalam FKUI/RSCM

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G

IN

A

lobal

itiative for

sthma

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Definition of Asthma

A chronic inflammatory disorder of the airways

Many cells and cellular elements play a role

Chronic inflammation is associated with airwayhyperresponsiveness that leads to recurrentepisodes of wheezing, breathlessness, chest

tightness, and coughing Widespread, variable, and often reversible

airflow limitation

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GINA Program Objectives

Increase appreciation of asthma as a global public

health problem

Present key recommendations for diagnosis andmanagement of asthma

Provide strategies to adapt recommendations to

varying health needs, services, and resources

Identify areas for future investigation of particular

significance to the global community

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Levels of Asthma Control(Preferably over 4 weeks)

Characterist icControlled

(All of the following)

Partly controlled(Any present in any week)

Uncontrolled

Daytime symptomsNone (2 or less /

week)

More than

twice / week

3 or more

features of

partly

controlled

asthma

present inany week

Limitations ofactivities

None Any

Nocturnal

symptoms /

awakening

None Any

Need for rescue /reliever

treatment

None (2 or less /

week)

More than

twice / week

Lung function

(PEF or FEV1)Normal

< 80% predicted or

personal best (if

known) on any day

Exacerbation None One or more / ear 1 in an week

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1.Develop Patient/DoctorPartnership

2. Identify and Reduce Exposureto Risk Factors

3.Assess, Treat and Monitor

Asthma4. Manage Asthma Exacerbations

Asthma Management and PreventionProgram: Five Components

Revised 2011

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Asthma Management and Prevention Program

Component 3: Assess, Treatand Monitor Asthma

The goal of asthma treatment, toachieve and maintain clinical

control, can be achieved in amajority of patients with apharmacologic intervention strategy

developed in partnership betweenthe patient/family and the healthcare professional

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Depending on level of asthma control,the patient is assigned to one of fivetreatment steps

Treatment is adjusted in a continuouscycle driven by changes in asthmacontrol status. The cycle involves:

- Assessing Asthma Control

- Treating to Achieve Control

- Monitoring to Maintain Control

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A stepwise approach to pharmacologicaltherapy is recommended

The aim is to accomplish the goals oftherapy with the least possible medication

Although in many countries traditionalmethods of healing are used, their efficacyhas not yet been established and their usecan therefore not be recommended



A th M t d P ti P

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The choice of treatment should be guided by:

Level of asthma control

Current treatment

Pharmacological properties and availabilityof the various forms of asthma treatment

Economic considerations

Cultural preferences and differing health caresystems need to be considered



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Component 4: Asthma Management and Prevention Program

Controller Medications

Inhaled glucocorticosteroids

Leukotriene modifiers

Long-acting inhaled 2-agonists Systemic glucocorticosteroids

Theophylline

Cromones

Long-acting oral 2-agonists

Anti-IgE

Systemic glucocorticosteroids

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Estimate Comparative Daily Dosages of Inhaled

Glucocorticosteroids for Adults and Children > 5 years

Drug Low Daily Dose (g) Medium Daily Dose (g) High Daily Dose (g)

Beclomethasone 200-500 >500-1000 >1000

Budesonide 200-400 400-800 800 - 1600

Budesonide-Neb

Inhalation Suspension

250-500 >500-1000 >1000

Ciclesonide 80 160 >160-320 >320-1280

Flunisolide 500-1000 >1000-2000 >2000

Fluticasone 100-250 >250-500 >500

Mometasone furoate 200-400 > 400-800 >800-1200

Triamcinolone acetonide 400-1000 >1000-2000 >2000

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Component 4: Asthma Management and Prevention Program

Reliever Medications

Rapid-acting inhaled 2-agonists

Anticholinergics

Theophylline

Short-acting oral 2-agonists

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Global Strategy for Asthma

Management and Prevention

Evidence Category Sources of Evidence

A Randomized clinical trials

Rich body of data

B Randomized clinical trialsLimited body of data

C Non-randomized trialsObservational studies

D Panel judgment consensus

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controlled

partly controlled

uncontrolled

exacerbation

LEVEL OF CONTROL

maintain and find lowest

controlling step

consider stepping up to

gain control

step up until controlled

treat as exacerbation

TREATMENT OF ACTION

TREATMENT STEPSREDUCE INCREASE

STEP

1

STEP

2

STEP

3

STEP

4

STEP

5

REDUCE

INCREASE

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Step 1 As-needed reliever medication

Patients with occasional daytime symptoms of

short duration

A rapid-acting inhaled 2-agonist is the

recommended reliever treatment (Evidence A)

When symptoms are more frequent, and/or

worsen periodically, patients require regular

controller treatment (step 2or higher)

Treating to Achieve Asthma Control

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Step 2 Reliever medication plus a singlecontroller

A low-dose inhaled glucocorticosteroid isrecommended as the initial controller

treatment for patients of all ages (Evidence A)

Alternative controller medications includeleukotriene modifiers (Evidence A)

appropriate for patients unable/unwilling to

use inhaled glucocorticosteroids


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Step 3

Reliever medication plus one or twocontrollers

For adults and adolescents, combine a low-dose

inhaled glucocorticosteroid with an inhaled long-acting 2-agonist either in a combination inhaler

device or as separate components (Evidence A)

Inhaled long-acting 2-agonist must not be usedas monotherapy

For children, increase to a medium-dose inhaled

glucocorticosteroid (Evidence A)


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Additional Step 3 Options for Adolescents and Adults

Increase to medium-dose inhaled

glucocorticosteroid (Evidence A) Low-dose inhaled glucocorticosteroid

combined with leukotriene modifiers

(Evidence A)

Low-dose sustained-release theophylline

(Evidence B)


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Step 4

Reliever medication plus two or morecontrollers

Selection of treatment at Step 4depends

on prior selections at Steps 2 and 3

Where possible, patients not controlled on

Step 3treatments should be referred to a

health professional with expertise in the

management of asthma


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Step 4

Reliever medication plus two or more controllers

Medium- or high-dose inhaled glucocorticosteroid

combined with a long-acting inhaled 2-agonist

(Evidence A)

Medium- or high-dose inhaled glucocorticosteroid

combined with leukotriene modifiers (Evidence A)

Low-dose sustained-release theophylline addedto medium- or high-dose inhaled

glucocorticosteroid combined with a long-acting

inhaled 2-agonist (Evidence B)


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Step 5

Reliever medication plus additional controller options

Addition of oral glucocorticosteroids to other

controller medications may be effective

(Evidence D) but is associated with severe

side effects (Evidence A)

Addition of anti-IgE treatment to othercontroller medications improves control of

allergic asthma when control has not been

achieved on other medications (Evidence A)

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Treating to Maintain Asthma Control

Stepping down treatment when asthma is controlled

When controlled on medium- to high-dose

inhaled glucocorticosteroids: 50% dosereduction at 3 month intervals (Evidence

B)

When controlled on low-dose inhaled

glucocorticosteroids: switch to once-daily

dosing (Evidence A)

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Stepping down treatment when asthma is controlled

When controlled on combination inhaled

glucocorticosteroids and long-actinginhaled 2-agonist, reduce dose of inhaledglucocorticosteroid by 50% whilecontinuing the long-acting 2-agonist

(Evidence B) If control is maintained, reduce to low-

dose inhaled glucocorticosteroids and

stop long-acting 2-agonist (Evidence D)

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Stepping up treatment in response to loss of control

Rapid-onset, short-acting or long-

acting inhaled 2-agonistbronchodilators provide temporaryrelief.

Need for repeated dosing over morethan one/two days signals need forpossible increase in controller therapy

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Stepping up treatment in response to loss of control

Use of a combination rapid and long-actinginhaled

2

-agonist (e.g.,formoterol) and aninhaled glucocorticosteroid (e.g.,budesonide)in a single inhaler both as a controller andreliever is effecting in maintaining a high levelof asthma control and reduces exacerbations(Evidence A)

Doubling the dose of inhaled glucocortico-steroids is not effective, and is not

recommended (Evidence A)

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Asthma management - a continuous process

is needed to ensure that controlis maintained

Adapted from GINA 2011 (www.ginasthma.org)

RESCUE USE

> 2 /WEEK

Party

Controlled

Uncontrolled

NOConsider

Step-upmaintenance

treatment

Initiate

treatment

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GINA 2009

When should you step down?

When control is maintained for at least 3

months, treatment can be stepped downwith the aim of establishing the lowest step

and dose of treatment that maintains

control

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ss

ICS/LABA 50/250g bd

n=660

ICS/LABA 50/100g bd

n=208

ICS 250g bd

n=188

12 16 20 24

ScreeningEnd of

treatment

SABA

only

2 0 4 8

Run-in period Double-blind treatment period

Weeks

Stepping-down Bateman study

Randomisation

Primary endpoint: mean morning PEF

Secondary endpoints:Asthma control, symptoms, and rescue albuterol usage

Bateman et al. J Allergy Clin Immunol 2006

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M i t f th t l

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Maintenance of asthma control

during step down

14 16 18 20 22 24

ICS 250 bid0

20

40

60

80

100

2 4 6 8 10 12

%o

fwell-controlle

dsubjects

Weeks

Open-label period

ICS/LABA 50/250

Run-in

Double-blind period

4 wks

Well

controlled

ICS/LABA 50/250 bid

(two lines show groups that were

randomised during blinded phase)

ICS/LABA 50/100 bid

Bateman et al. J Allergy Clin Immunol 2006

Conclusion: Stepping down to a lower dose of

ICS/LABA is more effective than switching to an ICS

alone

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THANK YOU

Asthma (Chest 2012)

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