7. Assessment of Asthma Control – Symptom control
Simple
Screening
Tools
Numerical
Control
Tools
eg, Asthma Control Test (ACT)
A. Symptom control
In the past 4 weeks, has the patient had:
Well-
controlled
Partly
controlled
Uncontrolled
• Daytime asthma symptoms more
than twice a week?
Yes No
None of
these
1-2 of
these
3-4 of
these
• Any night waking due to asthma?
Yes No
• Reliever needed for symptoms*
more than twice a week?
Yes No
10. 10
Risk factors for exacerbations include:
• Ever intubated for asthma
• Uncontrolled asthma symptoms
• Having ≥1 exacerbation in last 12 months
• Low FEV1 (measure lung function at start of treatment, at 3-6 months
to assess personal best, and periodically thereafter)
• Incorrect inhaler technique and/or poor adherence
• Smoking
• Elevated FeNO in adults with allergic asthma
• Obesity, pregnancy, blood eosinophilia
Risk factors for fixed airflow limitation include:
• No ICS treatment, smoking, occupational exposure, mucus
hypersecretion, blood eosinophilia
Assessment of risk factors for poor asthma outcomes
11. 11
Risk factors for exacerbations include:
• Ever intubated for asthma
• Uncontrolled asthma symptoms
• Having ≥1 exacerbation in last 12 months
• Low FEV1 (measure lung function at start of treatment, at 3-6 months
to assess personal best, and periodically thereafter)
• Incorrect inhaler technique and/or poor adherence
• Smoking
• Elevated FeNO in adults with allergic asthma
• Obesity, pregnancy, blood eosinophilia
Risk factors for fixed airflow limitation include:
• No ICS treatment, smoking, occupational exposure, mucus
hypersecretion, blood eosinophilia
Risk factors for medication side-effects include:
• Frequent oral steroids, high dose/potent ICS, P450 inhibitors
Assessment of risk factors for poor asthma outcomes
12. 12
• How?
– Asthma severity is assessed retrospectively from the
level of treatment required to control symptoms and
exacerbations
• When?
– Assess asthma severity after patient has been on
controller treatment for several months
– Severity is not static – it may change over months or
years, or as different treatments become available
Assessment of Asthma Severity
13. 13
Categories of asthma severity
– Mild asthma:
well-controlled with Steps 1 or 2 (as-needed SABA
or low dose ICS)
– Moderate asthma:
well-controlled with Step 3 (low-dose ICS/LABA)
– Severe asthma:
requires Step 4/5 (moderate or high dose
ICS/LABA ± add-on), or remains uncontrolled despite
this treatment
14. Step 1
Step 2
Step 3
Step 4
Step 5
NoYes
NoYes
NoYes
NoYes
Was required treatment provided, symptoms controlled and
exacerbations prevented?
Control Severity
Mild
Moderate
Severe
Treatment
Severity is not static. It may change over months or years
18. How do we apply the
stepwise approach?
•
Maintain control
by stepping up
treatment as
necessary.
19. Stepping down
Ensure regular review of
patients as treatment is
stepped down
Decide which drug to step
down first and at what rate
When control is
good,
step down
24. Children’s Healthcare of AtlantaGINA 2017, Box 3-5, Step 1
PREFERRED
CONTROLLER
CHOICE
Other
controller
options
RELIEVER
STEP 1 STEP 2
STEP 3
STEP 4
STEP 5
Low dose ICS
Consider low
dose ICS
Leukotriene receptor antagonists (LTRA)
Low dose theophylline*
Med/high dose ICS
Low dose ICS+LTRA
(or + theoph*)
As-needed short-acting beta2-agonist (SABA) As-needed SABA or
low dose ICS/formoterol#
Low dose
ICS/LABA**
Med/high
ICS/LABA
*Not for children <12 years
**For children 6-11 years, the preferred Step 3 treatment is medium dose ICS
#For patients prescribed BDP/formoterol or BUD/ formoterol maintenance and reliever therapy
Tiotropium by mist inhaler is an add-on treatment for patients ≥12 years with a history of exacerbations
Add tiotropium*
High dose ICS
+ LTRA
(or + theoph*)
Add low
dose OCS
Refer for
add-on
treatment
e.g.
tiotropium,*
anti-IgE,
anti-IL5*
Step 1 – as-needed inhaled short-acting
beta2-agonist (SABA)
25. Children’s Healthcare of AtlantaGINA 2017, Box 3-5, Step 1
Step 1 – as-needed inhaled short-acting
beta2-agonist (SABA)
• Preferred option: as-needed inhaled short-acting beta2-
agonist (SABA)
– SABAs are highly effective for relief of asthma symptoms
– However …. there is insufficient evidence about the safety of
treating asthma with SABA alone
– This option should be reserved for patients with infrequent
symptoms (less than twice a month) of short duration, and with
no risk factors for exacerbations
• Other options
– Consider adding regular low dose inhaled corticosteroid (ICS)
for patients at risk of exacerbations
26. Children’s Healthcare of AtlantaGINA 2017, Box 3-5, Step 2 (5/8)
PREFERRED
CONTROLLER
CHOICE
Other
controller
options
RELIEVER
STEP 1 STEP 2
STEP 3
STEP 4
STEP 5
Low dose ICS
Consider low
dose ICS
Leukotriene receptor antagonists (LTRA)
Low dose theophylline*
Med/high dose ICS
Low dose ICS+LTRA
(or + theoph*)
As-needed short-acting beta2-agonist (SABA) As-needed SABA or
low dose ICS/formoterol#
Low dose
ICS/LABA**
Med/high
ICS/LABA
*Not for children <12 years
**For children 6-11 years, the preferred Step 3 treatment is medium dose ICS
#For patients prescribed BDP/formoterol or BUD/ formoterol maintenance and reliever therapy
Tiotropium by mist inhaler is an add-on treatment for patients ≥12 years with a history of exacerbations
Refer for
add-on
treatment
e.g.
tiotropium,*
anti-IgE,
anti-IL5*
Add tiotropium*
High dose ICS
+ LTRA
(or + theoph*)
Add low
dose OCS
Step 2 – low-dose controller + as-needed
inhaled SABA
29. Children’s Healthcare of AtlantaGINA 2017, Box 3-5, Step 1
Start controller treatment early
– For best outcomes, initiate controller treatment as early
as possible after making the diagnosis of asthma
Indications for regular low-dose ICS - any of:
– Asthma symptoms more than twice a month
– Waking due to asthma more than once a month
– Any asthma symptoms plus any risk factors for
exacerbations
Recommended Initial Treatment Step
32. Children’s Healthcare of AtlantaGINA 2017, Box 3-5, Step 1
Consider starting at a higher step if:
– Troublesome asthma symptoms on most days
– Waking from asthma once or more a week,
especially if any risk factors for exacerbations
If initial asthma presentation is with an exacerbation:
– Give a short course of oral steroids and start regular
controller treatment (e.g. high dose ICS or medium
dose ICS/LABA, then step down)
Recommended Initial Treatment Step
34. Recommended Initial Treatment Step
Step Frequency of Asthma Symptoms /
Frequency of SABA Use
Risk Factors for
Exacerbations
1 < Twice a month ---
2 Twice a month – twice a week ---
2 < Twice a month +
3 Twice a month – twice a week +
4 Troublesome asthma symptoms most days +
5 Initial presentation with severely
uncontrolled asthma or an asthma
exacerbation
+
35. Children’s Healthcare of AtlantaGINA 2017, Box 3-5, Step 1
Practical issues
• Inhaler technique - can the patient use the device correctly after
training?
• Adherence: how often is the patient likely to take the medication?
• Cost: can the patient afford the medication?
After starting initial controller treatment
– Review response after 2-3 months, or according to clinical
urgency
– Adjust treatment (including non-pharmacological treatments)
– Consider stepping down when asthma has been well-controlled
for 3 months
37. Treatment Options for adult Patients
Not Controlled on Iow dose ICS
Patients not controlled on inhaled steroids (ICS)Patients not controlled on inhaled steroids (ICS)Patients not controlled on inhaled steroids (ICS)Patients not controlled on inhaled steroids (ICS)
Increase theIncrease the
dose of inhaleddose of inhaled
steroidsteroid
Add leukotrieneAdd leukotriene
receptorreceptor
antagonistsantagonists
Add long-acting
beta2-agonists
Add SRAdd SR
theophyllinetheophylline
38. 38
Step 3 – one or two controllers + as-needed inhaled reliever
39. 39
Step 3 – one or two controllers + as-needed inhaled reliever
40. Children’s Healthcare of Atlanta 40
Step 3 – one or two controllers + as-needed inhaled reliever
• Children 6-11 years:
preferred option is medium dose ICS with as-needed
SABA
• Other options
– Adults/adolescents: Increase ICS dose or add LTRA or SR
theophylline (less effective than ICS/LABA)
– Adults: consider adding SLIT ( Non-pharmacological
interventions)
– Children 6-11 years – add LABA (similar effect as
increasing ICS)
UPDATED
2017
42. Children’s Healthcare of Atlanta
ICS/LABA combination therapy
Different ICS/LABA combinations
• Fluticasone propionate/salmeterol MDI and DPI
– Different strenght, standard dosing
• Budesonide/formoterol DPI
– Single strenght, different dosing
• BDP/formoterol MDI and DPI
– Single strenght, different dosing
• Fluticasone propionate/formoterol MDI
– Different strenght, standard dosing
• Fluticasone furoate/vilanterol DPI
– Different strenght, once daily
Different indications
– Traditional treatment vs maintenance and reliever treatment
– Different severity ?
54. Children’s Healthcare of Atlanta
Evolution in Asthma Management
Therapy used over time
MedicationUse
Maintenance
+ prn SABA
Maintenance
+ prn Symbicort
One inhaler:
Maintenance &
relief
Rapid adjustments in
controller replacing
SABA
No adjustment in
controller
SMART =
Single inhaler Maintenance
And Reliever Therapy
GOAL
55. Shaded green - preferred controller options
TO STEP 3 TREATMENT,
SELECT ONE OR MORE:
TO STEP 4 TREATMENT,
ADD EITHER
GINA 2013
64. 64
• Add-on tiotropium by soft-mist
inhaler is a new ‘other controller
option’ for Steps 4 and 5, in patients
≥ 18 years with history of
exacerbations
What’s new in GINA 2015
65. Children’s Healthcare of AtlantaGINA 2017, Box 3-5, Step 1
Step 4 – two or more controllers + as-needed
inhaled reliever
• Before considering step-up
– Check inhaler technique and adherence
• Adults or adolescents:
preferred option is :
• Combination low dose ICS/formoterol as maintenance and
reliever regimen*, OR
•
Combination medium dose ICS/LABA with as-needed
SABA
*Approved only for low dose beclometasone/formoterol and low dose
budesonide/formoterol
66. Children’s Healthcare of AtlantaGINA 2017, Box 3-5, Step 1
Other options (adults or adolescents)
– Tiotropium by mist inhaler may be used as add-on therapy
for patients aged ≥12 years with a history of exacerbations
– Adults: consider adding SLIT (Non-pharmacological therapy)
– Trial of high dose combination ICS/LABA, but little extra
benefit and increased risk of side-effects
– Increase dosing frequency (for budesonide-containing
inhalers)
– Add-on LTRA or low dose theophylline
Step 4 – two or more controllers + as-needed
inhaled reliever
UPDATED
2017
67. 67
Consider adding SLIT sublingual immunotherapy (SLIT)
in adult HDM-sensitive patients with allergic rhinitis
and asthma who have exacerbations despite ICS
treatment, provided FEV1 is 70% predicted
In such patients with exacerbations despite taking step 3
or step 4 therapy (according to GINA),SLIT can
now be considered as add on therapy
UPDATED
2017
68. Children’s Healthcare of Atlanta
Step 5 – higher level care and/or add-on
treatment
GINA 2017, Box 3-5, Step 5 (8/8)
Other
controller
options
RELIEVER
STEP 1 STEP 2
STEP 3
STEP 4
STEP 5
Low dose ICS
Consider low
dose ICS
Leukotriene receptor antagonists (LTRA)
Low dose theophylline*
Med/high dose ICS
Low dose ICS+LTRA
(or + theoph*)
As-needed short-acting beta2-agonist (SABA)
Low dose
ICS/LABA**
Med/high
ICS/LABA
PREFERRED
CONTROLLER
CHOICE
UPDATED
2017
*Not for children <12 years
**For children 6-11 years, the preferred Step 3 treatment is medium dose ICS
#For patients prescribed BDP/formoterol or BUD/ formoterol maintenance and reliever therapy
Tiotropium by mist inhaler is an add-on treatment for patients ≥12 years with a history of exacerbations
Refer for
add-on
treatment
e.g.
tiotropium,*
anti-IgE,
anti-IL5*
As-needed SABA or
low dose ICS/formoterol#
Add tiotropium*
High dose ICS
+ LTRA
(or + theoph*)
Add low
dose OCS
69. Children’s Healthcare of Atlanta
• Preferred option is referral for specialist investigation and consideration
of add-on treatment
– If symptoms uncontrolled or exacerbations persist despite Step 4
treatment, check inhaler technique and adherence before referring
– Add-on tiotropium for patients ≥12 years with history of exacerbations
– Add-on omalizumab (anti-IgE) for patients with severe allergic asthma
– Add-on mepolizumab (anti-IL5) for severe eosinophilic asthma (≥12
yrs)
• Other add-on treatment options at Step 5 include:
– Sputum-guided treatment: this is available in specialized centers; reduces
exacerbations and/or corticosteroid dose
– Add-on low dose oral corticosteroids (≤7.5mg/day prednisone
equivalent): this may benefit some patients, but has significant systemic
side-effects. Assess and monitor for osteoporosis
– See ERS/ATS Severe Asthma Guidelines (Chung et al, ERJ 2014) for more
detail
GINA 2016
Step 5 – higher level care and/or add-on treatment
2016
70. Children’s Healthcare of AtlantaGINA 2016
Step 5 – higher level care and/or add-on treatment
2017
• Preferred option is referral for specialist investigation and consideration
of add-on treatment
– If symptoms uncontrolled or exacerbations persist despite Step 4 treatment,
check inhaler technique and adherence before referring
– Add-on tiotropium for patients ≥12 years with history of exacerbations
– Add-on anti-IgE (omalizumab) for patients with severe allergic asthma
– Add-on anti-IL5 (mepolizumab (SC) or reslizumab (IV) for severe
eosinophilic asthma (≥12 yrs)
• Other add-on treatment options at Step 5 include:
– Sputum-guided treatment: this is available in specialized centers; reduces
exacerbations and/or corticosteroid dose
– Add-on low dose oral corticosteroids (≤7.5mg/day prednisone
equivalent): this may benefit some patients, but has significant
systemic side-effects. Assess and monitor for osteoporosis
– See ERS/ATS Severe Asthma Guidelines (Chung et al, ERJ 2014) for more
detail
UPDATED
2017
72. 72
Omalizumab
Recombinant DNA-derived, humanized antibody
First FDA-approved biologic : 2003
Age ≥ 12 yr --> In July 2016, FDA approved Age ≥ 6
yr Moderate-to- severe persistent asthma whose
disease is not adequately controlled with ICSs +
LABA
73. 73
Mepolizumab
Humanized IgG1 mAb against IL-5 FDA
Approved : Nov 2015
Age ≥ 12 yr
Severe eosinophilic asthma
- Blood eosinophils ≥ 150 cells/µl at initiation of Rx
OR ≥ 300 cells/µl in the past 12 months
100 mg SC q 4 wk
NUCALA
(mepolizumab)
74. 74
CINQUIR (Reslizumab)
Humanized IgG4 kappa mAb against IL-5 FDA
approved : March 2016
Age > 18 yr
Severe eosinophilic asthma
Blood eosinophils > 400 cells/µl at initiation of
Rx 3 mg/kg q 4 wk IV infusion over 20-50 min
Reslizumab
Both severity and control are assessed based on treatment.
Severity Is assessed according to treatment required.
Control is assessed according to how far the required treatment is implemented and how far the expected therapeutic response is achieved.
To get the best results it is necessary to establish the optimal treatment for each patient on an individual basis.
It is important to control symptoms as quickly as possible, so starting treatment at a very low level and building up slowly is not appropriate.
Ask the audience if they have real case histories to demonstrate stepping up treatment to achieve optimal control.
It is equally important not to over-treat.
The point being made by this slide is that Symbicort single inhaler therapy (SSIT) or Symbicort maintenance and reliever therapy (SMART) is different from any other adjustable approach such as SAMD, GOAL or the Sont and Green studies which were all dependent on a complex algorithm to adjust maintenance treatment.
With SMART adjustment becomes automatic based on the need for reliever
