8. Step 2 Step 3 Step 4 Step 5Step 1
Asthma Education
Enviromental Control
As needed
rapid acting
2 agonists
As needed rapid acting 2 agonists
Controller
options
Select one Select one Add one or
more
Add one or
both
Low-dose ICS Low-dose ICS +
LABA
Medium or high
dose ICS+
LABA
Oral steroid
LTRA Medium or high
dose ICS
LTRA Anti-IgE
Low-dose ICS
+ LTRA
Theophylline
Low-dose ICS
+ Theophylline
INCREASEREDUCE TREATMENT STEPS
GINA 2013
As needed rapid acting B2-agonist
14. 14
• 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
15. 15
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
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.
21. Step 1 treatment is for
patients with symptoms
<twice/month
Previously, no controller
was recommended for
Step 1, i.e. SABA-only
treatment was
‘preferred’
GINA 2018 – main treatment figure
22.
23. 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
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
Step 1 – as-needed reliever inhaler 2018
GINA 2017
24.
25. Daily Low dose ICS has been suggested by GINA since 2014 in step1
to reduce the risk of severe exacerbations .
However, patients with symptoms less than twice a month are unlikely
to take ICS regularly, leaving them exposed to the risks of SABA-only
treatment.
26.
27.
28. Preferred option: regular low dose ICS with as-needed inhaled SABA
Low dose ICS reduces symptoms and reduces risk of exacerbations and asthma-
related hospitalization and death
Other options
Leukotriene receptor antagonists (LTRA) with as-needed SABA
Less effective than low dose ICS
May be used for some patients with both asthma and allergic rhinitis, or if patient will not
use ICS
Combination low dose ICS/long-acting beta2-agonist (LABA) with as-needed
SABA
Reduces symptoms and increases lung function compared with ICS
More expensive, and does not further reduce exacerbations
Intermittent ICS with as-needed SABA for purely seasonal allergic asthma with no
interval symptoms
Start ICS immediately symptoms commence, and continue for 4 weeks after pollen season
ends
Step 2 – Low dose controller + as-needed SABA 2018
GINA 2017
31. GINA 2017, Box 3-5, Step 1 (4/8)
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. Treatment Options for adult Patients
Not Controlled on low dose Inhaled Steroids
Patients not controlled on Low dose ICS
Increase the
dose of inhaled
steroid
Add leukotriene
receptor
antagonists
Add long-acting
beta2-agonists
Add
theophylline
33.
34. 35
Step 3 – one or two controllers + as-needed inhaled
reliever
48. Combination inhalers of salmeterol with an ICS, such as Seretide,
are not suitable for single inhaler maintenance and reliever therapy.
Salmeterol should not be used for the relief of acute asthma
symptoms because it has a significantly slower onset of action than
either formoterol, salbutamol or terbutaline.
49
53. 55
• 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
55. 57
Consider adding 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
60. ClAdd-on Controller Medication
Long-acting anticholinergic (At Step 4 or 5 with a history of
exacerbations despite ICS ± LABA) :
Tiotropium
Anti-IgE (with severe allergic asthma uncontrolled on high dose ICS-
LABA):
Omalizumab
61. ClAdd-on Controller Medication
Anti-IL5 & Anti-IL5R (Severe eosinophilic asthma uncontrolled on high dose
ICS-LABA)
Mepolizumab & Reslizumab
Benralizumab
Anti-IL4R (Severe eosinophilic asthma uncontrolled on high dose ICS-LABA,
or requiring maintenance OCS)
Dupilumab
65. ClStarting Asthma Treatment
ICS-containing treatment should be initiated as soon as possible
after the diagnosis of asthma is made.
Consider starting at a higher step (e.g. medium/high dose ICS, or
low-dose ICS-LABA) if on most days the patient has troublesome
asthma symptoms; or is waking from asthma once or more a
week.
66. ClStarting Asthma Treatment
If the initial asthma presentation is with severely uncontrolled
asthma, or with an acute exacerbation, give a short course of OCS
and start regular controller treatment (e.g. medium dose ICS-LABA).
Consider stepping down after asthma has been well controlled for 3
months. However, in adults and adolescents, ICS should not be
completely stopped.
68. CAfter Starting Initial Controller Treatment
Review response after 2–3 months, or according to clinical urgency.
Review for ongoing treatment and other key management issues.
Consider step down when asthma has been well controlled for 3 months.
69. C
Reviewing response and adjusting treatment
Patients should preferably be seen 1–3 months after starting treatment
Every 3–12 months after that, but in pregnancy, asthma should be
reviewed every 4–6 weeks.
After an exacerbation, a review visit within 1 week should be scheduled.
70. C
Stepping up treatment
Sustained step-up (for at least 2–3 months): if symptoms and/or
exacerbations persist despite 2–3 months of controller treatment, assess
the following common issues before considering a step-up
• Incorrect inhaler technique
• Poor adherence
• Modifiable risk factors
• Comorbid conditions
71. C
Stepping up treatment
Short-term step-up (for 1–2 weeks) by clinician or by patient with written
asthma action plan, e.g. during viral infection or allergen exposure.
Day-to-day adjustment by patient for those who prescribed as-needed
low dose ICS formoterol for mild asthma, or low dose ICS-formoterol as
maintenance and reliever therapy.
72. C
Stepping down treatment
Consider stepping down treatment once good asthma control has been
achieved and maintained for 3 months, to find the lowest treatment that
controls both symptoms and exacerbations, and minimizes side-effects.
73. C
Stepping down treatment
Choose an appropriate time for step-down (no respiratory infection, patient
not travelling, not pregnant).
Document baseline status (symptom control and lung function), provide a
written asthma action plan, monitor closely and book a follow-up visit.
86. Many guidelines over the past 50 years have recommended SABA as
the first line to treat asthma and to move on to ICS when that proved
to be unsuccessful in controlling symptoms.
For safety, GINA no longer recommends SABA only treatment for Step
1
This decision was based on evidence that SABA-only treatment increases
the risk of severe exacerbations, and that adding any ICS significantly
reduces the risk.
87. Background to changes in 2019
Risks of SABA-only treatment
Regular or frequent use of SABA is associated with adverse effects
β-receptor downregulation, decreased bronchoprotection, rebound
hyperresponsiveness, decreased bronchodilator response (Hancox, Respir
Med 2000)
Increased allergic response, and increased eosinophilic airway
inflammation (Aldridge, AJRCCM 2000).
88. Higher use of SABA is associated with adverse clinical outcomes :
Dispensing of ≥3 canisters per year (average 1.7 puffs/day) is associated with
higher risk of emergency department presentations (Stanford, AAAI 2012)
Dispensing of ≥12 canisters per year is associated with higher risk of death
(Suissa, AJRCCM 1994)
89. Background to changes in 2019
Risks of Mild Asthma
Epidemiological data shows that mild asthma accounts for 50 -75% of the total
population of asthma patients.
Mild asthma, often termed mild intermittent or mild persistent asthma, is
defined by the Global Initiative in Asthma (GINA) management strategy as
patients who meet the criteria for step 1 and step 2 treatment strategies.
Although these patients have fewer symptoms, they are the main and largest
subgroup of asthma patients.
90. “There is a perception that infrequent symptoms mean low-risk, but
the evidence is that patients with mild asthma still have severe
attacks”
Patients with apparently mild asthma are at risk of serious adverse
events
30–37% of adults with acute asthma
16% of patients with near-fatal asthma
15–20% of adults dying of asthma
91.
92.
93. Step 1 is for patients with symptoms less than twice a month, and with
no exacerbation risk factors
As-needed low dose ICS-formoterol (off-label)
Evidence
Indirect evidence from SYGMA 1 of large reduction in severe exacerbations
SABA-only treatment in patients eligible for Step 2 therapy (O’Byrne, NEJMed
Step 1 – ‘preferred’ controller option
94. Low dose ICS taken whenever SABA is taken (off-label)
As Separate or Combination ICS and SABA inhalers
Evidence
Indirect evidence from studies in patients eligible for Step 2 treatment
(BEST, TREXA, BASALT)
Daily Low dose ICS is no longer listed as a Step 1 option
This was included in GINA 2014 -2018, but with high probability of
adherence
Now replaced by more feasible as-needed controller options for Step 1
Step 1 - other controller option
95. The new GINA 2019 asthma treatment recommendations represent
significant shifts in asthma management at Steps 1 and 2 of the 5
treatment steps.
The report acknowledges an emerging body of evidence suggesting the
non safety of SABAs overuse in the absence of concomitant controller
medications.
96. The new GINA 2019 does not support SABA-only therapy in mild
asthma and has included new off-label recommendations such as :
Symptom-driven (as-needed) low dose ICS-formoterol or
“Low dose ICS taken whenever SABA is taken”.
These recommendations represent a clear deviation from decades of
clinical practice mandating the use of symptom-driven SABA treatment
alone in those with mild asthma.
97.
98. Step 2 – there are two ‘preferred’ controller options
1- Regular low dose ICS with as-needed SABA
For patients requiring Step 2 treatment, GINA 2019 has retained the
previous recommendation for preferred controller treatment as daily low
dose ICS with as needed SABA .
This is based on cumulative evidence demonstrating that regular low dose
use substantially reduces asthma symptoms, increases lung function,
improves QoL and reduces risks of severe exacerbations, hospitalizations
or death.
99. Step 2 – there are two ‘preferred’ controller options
1- Regular low dose ICS with as-needed SABA
For patients requiring Step 2 treatment, GINA 2019 has retained the
previous recommendation for preferred controller treatment as daily low
dose ICS with as needed SABA .
This is based on cumulative evidence demonstrating that regular low dose
use substantially reduces asthma symptoms, increases lung function,
improves QoL and reduces risks of severe exacerbations, hospitalizations
death.
Poor adherence with ICS is common in mild asthma , and that this would
expose patients to the risks of SABA-only treatment .
100. Step 2 – there are two ‘preferred’ controller options
2- As-needed low dose ICS-formoterol (off-label; all evidence with budesonide-
formoterol)
Another preferred controller option in Step 2 in the 2019 GINA
recommendations is the newly included, as-needed low dose ICS-formoterol
label) combination which reflects the clinical concern of non-adherence to
low dose ICSs in people with milder forms of asthma (needing Step 1 and Step
treatment) and resultant exposure to SABA monotherapy with such non-
adherence,
101. Step 2 – other controller options
1- Low dose ICS taken whenever SABA taken (off-label, separate or combination
inhalers)
2-Another option: leukotriene receptor antagonist (less effective for
exacerbations)
