5. Asthma Guidelines
5
1989
1st expert
panel
convened
1991
EPR-1
1993
GINA
founded
1995
1st GINA
guideline
1997
EPR-2
2002
Focused
update of
GINA
guideline
2002
Focused
update of
EPR-2
2006
GINA
guideline
major
revision
2007
EPR-3
2014
GINA
guideline
major
revision
EPR= National Heart, Lung, and Blood Institute (NHLBI). National Asthma
Education and Prevention Program (NAEPP). Expert Panel Report (EPR):
Guidelines for the Diagnosis and Management of Asthma
GINA= Global Initiative for Asthma.
Global Strategy for Asthma
Management and Prevention.
2011
EPR-3 quick-
reference guide
updated
8. 8
In susceptible individuals, inflammatory symptoms
are usually associated with widespread but variable
airflow obstruction and an increase in airway
response to a variety of stimuli.
Obstruction is often reversible, either spontaneously
or with treatment.
Asthma definition
11. 11
• Inflammation in asthma patients can be present
during symptom-free periods:
Symptoms resolve quickly. Inflammation,
as measured by airway hyperresponsiveness,
far longer time .
As chronic inflammation causes an increase in
airway hyperresponsiveness, if the inflammation
is not controlled, symptoms are likely to reoccur.
12. 12
Can asthma be cured?
Asthma is an eminently controllable illness. Indeed,
most sufferers, control is so effective that it amounts
a virtual cure. But asthma is not curable
Asthma is a long-term disease that has no cure. The
goal of asthma treatment is to control the disease.
13. Asthma Goals of Therapy
13
Reduce Impairment
Prevent and control symptoms (e.g. SOB,
coughing) Reduce use of SABA for quick-relief of symptoms
Maintain near normal pulmonary function
Maintain normal activity levels
Reduce Risk
Prevent acute exacerbations
Prevent ED visits and hospitalizations
Prevent progressive loss of lung function
Minimize adverse effects of pharmacotherapy
www.ginasthma.org
17. 17
Controllers =
Medications taken
daily on a long-term
basis to keep asthma
under clinical control
due to
antiinflammatory
effects
Relievers =
Medications used
on an as-needed
basis that act
quickly to reverse
bronchoconstriction
and relieve its
symptoms
Controllers Vs Relievers
23. 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 2006
As needed rapid acting B2-agonist
31. 31
The use of short-acting inhaled beta2-agonists on
a daily basis, or increasing use, indicates
inadequate asthma control & the need for
additional long term control therapy.
32. 32
Increasing use of SABA treatment or the use of SABA > 3
3 doses a week for symptom relief (not prevention of
EIB) generally indicates inadequate asthma control and
the need for initiating or intensifying anti-inflammatory
therapy.
Regularly scheduled, daily, chronic use of SABA is not
recommended.
34. 34
Good asthma control is associated with little or no need for
short-acting β2 agonist.
Anyone prescribed more than one short acting bronchodilator
inhaler device a month should be identified and have their
asthma assessed urgently and measures taken to improve
asthma control if this is poor.
38. 38
• Inhaled corticosteroids are the recommended &
most effective preventer drug for adults and children
with asthma , for achieving overall treatment goals.
51. 51
1. Oropharyngeal candidiasis
2. Hoarseness
3. Coughing
To reduce the potential for adverse affects:
Use the lowest dose necessary to maintain control.
Administer with spacers/holding chambers.
Advise patients to (Rinse with water , gargle and
spit out) after inhalation.
Local side effects
58. 58
Fate of inhaled drugs – Good Technique
Swallowed
GI tract
Deposited in lung
Lungs
Metabolism or absorption
from the lung
Liver
Oral
bioavailability
Absorption
from gut
First-pass
metabolism
Systemic
Circulation
Mouth
pharynx
mucociliary
clearance
80%
20%
Schematic representation of potential dose distribution
A Guide to Aerosol Delivery Devices for Respiratory Therapists. American Association for
Respiratory Care. 1st Edition. Page 1.
Webpage: http://www.aarc.org/education/aerosol_devices/
Adapted from Barnes et al. AJRCCM 1998;157:S1-S53
59. 59
Fate of inhaled drugs – Good Technique
Swallowed
GI tract
Deposited in lung
Lungs
Metabolism or absorption
from the lung
Liver
Oral
bioavailability
Absorption
from gut
First-pass
metabolism
Systemic
Circulation
Mouth
pharynx
mucociliary
clearance
80%
20%
Schematic representation of potential dose distribution
A Guide to Aerosol Delivery Devices for Respiratory Therapists. American Association for
Respiratory Care. 1st Edition. Page 1.
Webpage: http://www.aarc.org/education/aerosol_devices/
Adapted from Barnes et al. AJRCCM 1998;157:S1-S53
Swallowed
GI tract
Deposited in lung
Lungs
Metabolism or absorption
from the lung
Liver
Oral
bioavailability
Absorption
from gut
First-pass
metabolism
Systemic
Circulation
Mouth
pharynx
mucociliary
clearance
95%
5%
Schematic representation of potential dose distributionAdapted from Barnes et al. AJRCCM 1998;157:S1-S53
A Guide to Aerosol Delivery Devices for Respiratory Therapists. American Association for
Respiratory Care. 1st Edition. Page 1.
Webpage: http://www.aarc.org/education/aerosol_devices/
Fate of inhaled drugs – Poor Technique
60. 60
Inhaled medications is a waste of money if not used
properly
Poor technique is a barrier to good asthma control
Check at each visit
Don’t rely on patient’s knowledge – ask them to
demonstrate
62. 62
Stepping down therapy once asthma is controlled is
recommended , but often not implemented leaving
some patients overtreated.
Patients should be maintained at the lowest possible
dose of inhaled corticosteroid.
Reduction in inhaled corticosteroid dose should be
as patients deteriorate at different rates.
63. 63
Stepping down therapy
Reductions should be considered every three months,
decreasing the dose by approximately 25–50% each
Regular review of patients as treatment is stepped
is important .
64. 64
GINA 2016
When controlled on low-dose inhaled glucocorticosteroids:
switch to once-daily dosing (((
Consider stopping controller treatment only if there have
been no symptoms for 6–12 months, and patient has no
risk factors . Provide a written asthma action plan, and
monitor closely.
Complete cessation of ICS in adults is not advised as the
risk of exacerbations is increased
67. 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
68. 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
69. Stepwise Therapy- GINA 2017
Before stepping up, check:
Diagnosis
Adherence
69
Inhaler technique
Modifiable risk factors
www.ginasthma.org
Stepping up is a “Therapeutic Trial”
Sustained step up (2-3 months)
Short-term step up (1-2 weeks)
Day-today adjustment
78. 78
Long-acting inhaled β2 agonists should only be started
in patients who are already on inhaled corticosteroids,
and the inhaled corticosteroid should be continued.
The benefits of these medicines used in conjunction with
ICS in the control of asthma symptoms outweigh any
apparent risks.
Safety Of LABA
79. 1. Recent data indicating a possible increased risk of asthma
Related death associated with use of LABA in a
small group of individuals has resulted in increased
emphasis on the message that:
2. LABA should not be used as monotherapy in asthma & must
only be used in combination with an appropriate dose of
ICS.
92. 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.
92
93.
94. 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
105. Tiotropium
FDA approvals
2004: Handihaler® for COPD
2014: Respimat® for COPD
2015: Respimat® for asthma in ≥ 12
2017: Respimat® for asthma in ≥6
GINA 2018 Guidelines
In Steps 4 & 5 :
• Add-on therapy for adults/adolescents with a
history of exacerbations
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm; www.ginasthma.org
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What is the Respimat® Soft Mist™ Inhaler?
The Respimat® Soft Mist™ Inhaler is a highly
efficient and effective inhaler developed by
Boehringer Ingelheim1,2
It delivers a metered dosage of medication by
mechanical energy, without the use of propellants2,3
The Respimat® Soft Mist™ Inhaler delivers
medication in a slow-moving fine mist and is
designed to overcome problems such as2,3
Limited drug deposition in the lung
Reliance on adequate patient coordination
for effective inhalation
Use once daily in two consecutive puffs
(2.5 mcg per puff)1
1. Boehringer Ingelheim. Spiriva® Respimat® 2.5 mcg solution for inhalation. Summary of Product Characteristics. 2014. Available at:
https://www.medicines.org.uk/emc/medicine/20134/SPC/Spiriva+Respimat+2.5+micrograms+solution+for+inhalation/. Accessed: Sept 2014;
2. Moroni-Zentgraf P. RDD Europe 2013;1:141‒152; 3. Dalby R, et al. Int J Pharm 2004;283:1‒9.
109
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FOR INTERNAL USE ONLY. STRICTLY CONFIDENTIAL.
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Respimat® unique mist
• The Respimat® unique mist has all the properties needed for deep lung deposition
Aerosol velocity: the unique mist is slow-moving, allowing it to
follow the natural curve of the throat, resulting in lower deposition
in mouth and throat1
Aerosol duration: the unique mist cloud is long-lasting (1.5 s).
Patients have enough time to breathe in the medication1
Highly respirable, fine droplets: up to 77% of the droplets are in
the fine particle fraction, helping patients get the medication deep
into the lungs2
Respimat® generates a unique mist leading to deep lung deposition
Features and benefits
1. Hochrainer 2005.
2. Ziegler 2005.
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The Respimat® Soft Mist™ Inhaler delivers a higher
percentage dose than pMDIs
pMDI, pressurized metered-dose inhalers.
1. Brand, Int J COPD 2008;3:76370; 2. Zierenberg B. J Aerosol Med 1999;12 Suppl 1:S1924.
SLOW INHALATION
FINE
PARTICLES
1–5 µm
Whole lung deposition was higher with Respimat® Soft Mist™ Inhaler than
with pMDI in trained patients (53% of delivered vs. 21% of metered dose)
111
TOTAL LUNG DEPOSITION
Study undertaken in patients with COPD
116. Smoking is the Single Most Important
Risk Factor for COPD
Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease, Global Initiative for Chronic Obstructive
Lung Disease (GOLD) 2008. Available from: http://www.goldcopd.org.
117. 118
4–10%
of population
COPD is an important and increasing cause
of morbidity and mortality
Mathers 2006;
WHO 2015.
COPD remains a global health problem
COPD 5th
4th 3rd
2002 2015 2030
…leading cause of death in the world
122. COPD GOLD Guidelines
123
1998
GOLD
formed
2001
1st GOLD report
(spirometric grading)
2011
GOLD Major Revision
(ABCD multimodal grading)
2017
GOLD Major Revision
(refined ABCD
grading)
GOLD = Global Initiative for Chronic Obstructive Lung Disease
123. Common preventable & treatable disease
Characterized by persistent airflow limitation that is
usually progressive
Associated with an enhanced chronic inflammatory
response in the airways & the lung to noxious particles
or gases
Exacerbations & comorbidities contribute to the
overall severity in individual patients
Definition of COPD 2016
131. Frequent exacerbations are associated with
increased mortality
A = No exacerbations B = 1-2 exacerbations C = 3 or more exacerbations
Soler-Cataluna JJ, et al. Thorax 2005;60:925-931.
p < 0.0001
1.0
Probabilityofsurviving
0.8
0.6
0.4
0.2
0.0
0 10 20 30 40 50 60
Time (months)
A
B
C
p = 0.069
p < 0.0002
132. COPD is:
a multi- component disease
with systemic involvement & inflammation
Respiratory system
Systemic
inflammation
Target organs
QuickTime™ and a
TIFF (Uncompressed) decompressor
are needed to see this picture.
COPD is: More than just a lung disorder
139. Smoking cessation is the single most effective and
cost-effective intervention to reduce the risk of
developing COPD and stop its progression
(Evidence A)
141. Expiratory flow-limitation and lung hyperinflation that are only partially reversible
to bronchodilator therapy are pathophysiological hallmarks of COPD
142. V
BD
Air flowDeflation
Improvement in flow – FEV1
Improvement in volumes – FVC and IC
Bronchodilator therapy deflates the lung
BD = bronchodilator; V = ventilation; FEV1= forced expiratory volume in 1 second;
FVC= forced vital capacity; IC = inspiratory capacity
155. Children’s Healthcare of Atlanta
Proskocil BJ et al. Proc Am Thorac Soc. 2005;2(4):305-310.
SMC relaxationSMC contraction
M3- muscarinic
receptors
Beta Agonists
(LABA)Anticholinergics
(LAMA)
β2-adrenergic
receptors
Mechanisms of action of bronchodilators
on airway smooth muscle
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Combination inhalers in COPD
Symbicort 320 Turbohaler and Seretide 500 Accuhaler
167. Assessment of Symptoms
Best way to assess symptoms is to use validated
questionnaires:
Modified Medical Research Council dyspnea scale.
MMRC
COPD AssessmentTest CAT
178. 179
For Group C patients, it is recommended that treatment be
started with a single long-acting bronchodilator, preferably
a LAMA ( LAMA was superior to the LABA regarding
exacerbation prevention).
A second long-acting bronchodilator or the combination of
LABA/ICS may be used for persistent exacerbations;
The guidelines recommend LABA/LAMA as the addition of
ICS has been shown to increase pneumonia risk in some
patients.
180. 181
For Group D patients, a LABA/LAMA combination is
preferred as initial therapy over LABA/ICS as these patients
may be at higher risk of developing pneumonia with ICS
use.
For patients with high blood eosinophil counts or those with
asthma-COPD overlap, LABA/ICS could be considered first-
line therapy.
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Treatment of COPD: GOLD 2017
GOLD
Grade
Preferred Treatment For Continued Symptoms or
Exacerbations
A
PRN SABA or LABA
or SAMA or LAMA
Use alternative class
B LABA or LAMA LAMA + LABA
C LAMA
LAMA + LABA*
[or] LABA + ICS
D LAMA + LABA
LAMA + LABA + ICS
[or] LABA + ICS
182
*Preferred
GOLD 2017
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183. Children’s Healthcare of Atlanta
(C)
(D)
(A) (B)
LAMA + LABA LABA + ICS
LAMA
Further
exacerbation(s)
Continue, stop or try
alternative class of
bronchodilator
A bronchodilator
Evaluate effect A long-acting
bronchodilator
(LABA or LAMA)
Persistent
symptoms
LAMA + LABA
LAMA +
LABA + ICS
Further
exacerbation(s)
Further
exacerbation(s)
Consider roflumilast
if FEV1 <50% pred.
and patient has
chronic bronchitis
Consider
macrolide
(in former
smokers)
Persistent
symptoms/further
exacerbation(s)
Treatment algorithm by GOLD groups:
No role of ICS containing treatment in Groups A and B
GOLD
Group A
and B
completely
ICS-free
In patients with a major discrepancy between the perceived level of
symptoms
and severity of airflow limitation, further evaluation is warranted
Preferred
treatment
LAMA + LABA
LABA +
ICS
LAMA
184. Children’s Healthcare of Atlanta
(C)
(D)
(A) (B)
LAMA + LABA LABA + ICS
LAMA
Further
exacerbation(s)
Continue, stop or try
alternative class of
bronchodilator
A bronchodilator
Evaluate effect A long-acting
bronchodilator
(LABA or LAMA)
Persistent
symptoms
LAMA + LABA
LAMA +
LABA + ICS
Further
exacerbation(s)
Further
exacerbation(s)
Consider roflumilast
if FEV1 <50% pred.
and patient has
chronic bronchitis
Consider
macrolide
(in former
smokers)
Persistent
symptoms/further
exacerbation(s)
Treatment algorithm by GOLD groups:
Limited role of ICS containing treatment in Groups C & D
Preferred
treatment
LAMA + LABA
LABA +
ICS
LAMA
No
initiation
with ICS
containing
treatment
in GOLD
Groups C
and D*
*LABA/ICS may be the first choice in some patients. For example, those with
a history and/or findings suggestive of asthma-COPD overlap.
185. Children’s Healthcare of Atlanta
(C) (D)
(A) (B)
LAMA + LABA LABA + ICS
LAMA
Further
exacerbation(s)
Continue, stop or try
alternative class of
bronchodilator
A bronchodilator
Evaluate effect A long-acting
bronchodilator
(LABA or LAMA)
Persistent
symptoms
LAMA + LABA
LAMA +
LABA
LABA +
ICSLAMA
LAMA +
LABA + ICS
Further
exacerbation(s)
Further
exacerbation(s)
Consider
roflumilast if FEV1
<50% pred. and
patient has chronic
bronchitis
Persistent
symptoms/further
exacerbation(s)
Preferred
treatment
In patients with a major discrepancy between the perceived level of symptoms
and severity of airflow limitation, further evaluation is warranted
LAMA/LABA plays a
critical, central role
for GOLD B-D
Treatment algorithm by GOLD groups:
LAMA/LABA plays a central role for GOLD B-D
Consider
macrolide
(in former
smokers)
Consider roflumilast if
FEV1 <50% pred. and
patient has chronic
bronchitis
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188
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ICSs in stable COPD
ICSs do not modify the progressive decline in FEV1
or decrease mortality (level of evidence A).
The dose response with ICS in COPD is unknown (in
contrast to asthma treatment).
Moderate to high doses have been used in COPD
clinical trials.
1
8
9
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ICS/LABA combination therapy
Inhaled steroids not licensed for use in COPD except
as combination
ICS must be used in combination with LABA for
patients with COPD
ICS monotherapy only FDA approved for treatment of
asthma, not COPD
1
9
0
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Combination inhalers in COPD
Symbicort 320 Turbohaler and Seretide 500 Accuhaler
191. ICS-containing therapies currently over-used in management
of COPD
o More than 70% of patients with COPD are currently
receiving an ICS-containing therapy but, based on
guidelines, this should be less than 20%
o ICS should be reserved for those patients in whom
additional bronchodilation is failing to control their
exacerbations
ICS in combination with LABA have limited role in COPD
GOLD 2015 guidelines only recommend the addition of ICS to a
LABA in patients with an increased risk of exacerbations (Groups
and D)
The use of ICS-containing therapies in COPD
192. The use of ICS-containing therapies in COPD
Compared to non-ICS-containing therapies in COPD,
therapies containing ICS, eg, LABA/ICS FDC are associated
with greater risk of:
Pneumonia
Bone density decline and fractures
Candidiasis and skin lesions
Cataracts
Evidence linking ICS-containing therapies with increased
risk of diabetes mellitus
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Randomised
controlled trial
Observational
study
Systematic
review
Pneumonia X X X
Tuberculosis X
Bone fracture
(no effect on
fracture risk)
X X
Skin thinning/
easy bruising
X
Cataract X
Diabetes X
Oropharyngeal
candidiasis
X X X
Side effects of ICS in COPD and type of evidence
Price D. Prim Care Respir J 2013; 22: 92-100.
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Discontinuation of ICS reduces the risk of serious pneumonia
associated with long-term ICS use
196
* Retrospective analysis using the Quebec health insurance databases for COPD patients discontinued from ICS during 1990-2005 (n=103,386).
ICS=inhaled corticosteroid; RR=rate ratio.
Suissa S et al. Chest 2015;148(5):1177-1183.
20% reduction
after 1month
The overall risk of serious pneumonia was reduced by 37% following ICS discontinuation
50% reduction
after 4 months
0.5
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1
9
7
Is ICS Withdrawal or Step Down
Therapy Possible in COPD ?
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WISDOM study
The impact of stepwise withdrawal of
inhaled corticosteroids on exacerbations
in COPD patients
Magnussen H et al.: Withdrawal of Inhaled Glucocorticoids and Exacerbations of COPD
N Engl J Med 2014;371:1285-94
For internal use only – strictly confidential. Do not copy, detail or distribute externally.
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1
9
9
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2
0
0
WISDOM (Withdrawal of Inhaled Steroids During
Optimised bronchodilator Management) study
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Study design
6-7 0
S
C
R
E
E
N
I
N
G
Treatment
52Week -6
ICS
(remained on triple therapy from run-in)
Stepwise ICS withdrawal
(remained on dual bronchodilator)
Run-in
Triple
therapy
12
R
A
N
D
O
M
I
S
A
T
I
O
N
ICS stepwise withdrawal Stable
treatmen
t
Reduced to 250 µg BID
Reduced to 100 µg BID
Reduced to 0 µg (placebo)
Fluticasone propionate 12-week
withdrawal schedule
500 µg BID
18
• Tiotropium 18 µg QD
• Salmeterol 50 µg BID
• Fluticasone propionate 500 µg BID
Triple therapy
regimen
Magnussen H et al N Engl J Med 2014;371:1285-94
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With regard to the risk of exacerbations, the majority of patients with
stable severe COPD can be satisfactorily managed with appropriate
inhaled bronchodilator therapy alone
And even those with a higher blood eosinophil count (≥300 cells/µL or
≥4%) who may benefit from an additional treatment with ICS should
also be assessed for risks and benefits of ICS therapy
Conclusions
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2
0
3
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