29. 29
Expiratory flow-limitation and lung hyperinflation that are only partially reversible to
bronchodilator therapy are pathophysiological hallmarks of COPD
30. Children’s Healthcare of Atlanta
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
42. 42
Less symptoms
High risk
Less symptoms
High risk
Less symptoms
Low risk
Less symptoms
Low risk
More symptoms
high risk
More symptoms
high risk
More symptoms
low risk
More symptoms
low risk
(GOLDClassificationofAirflowLimitation)
Risk
CAT < 10
Breathlessness
mMRC 0–1 mMRC ≥ 2
Symptoms CAT≥10
≥2
or
1 (not leading
to hospital
admission)
0
≥1 leading
to hospital
admission
GOLD 2011 Combined assessment of COPD
49. 49
Bronchodilators
Continue , stop or
try alternative
class of
bronchodilators
Evaluate effect
Group A Group B
A long – acting bronchodilators
( LABA or LAMA )
LAMA + LABA
Persistent
Symptoms
Group C
LAMA
LAMA + LABA LABA + ICS
Further
exacerbation(s)
Group D
LAMA LAMA + LABA LABA + ICS
LAMA
+ LABA
+ ICS
Consider Roflumilast
if FEV1 50% pred.˂
And patient has
chronic bronchitis
Consider
macrolides in
former smokers
Further exacerbation(s)
Further
exacerbation(s)
Persistent
Symptoms / further
exacerbation(s)
51. 51
• "This is a major revision of the GOLD document since
2011 and is a step forward for individualised COPD
management.
• The updated pharmacotherapy recommendations are
now based solely on two factors, symptoms and
exacerbation history,"
GOLD2017GOLD2017
52. 52
Revised combined COPD assessment
• A refinement of the ABCD assessment tools is proposed that
separates spirometric grades from the “ ABCD “ groups
• ABCD groups will be derived exclusively from patient
symptoms & exacerbations history
• Spirometery in conjugation with patient symptoms &
exacerbation history remains vital for :
1) Diagnosis
2) Prognostication
3) Therapeutic approaches
56. 56
All Group A patients should be offered bronchodilators
treatment based on it’s effect on breathlessness ( this
can be either short- or long-acting bronchodilator ) .
This should be continued if symptomatic benefits is
documented.
if necessary, an alternative class of bronchodilator
(alternative mono bronchodilator )can be used if benefit
is not achieved with the first.
58. 58
Group B
A long – acting bronchodilators
( LABA or LAMA )
LAMA + LABA
Persistent
Symptoms
59. 59
For Group B patients, therapy should begin with a long-
acting bronchodilator LABA or LAMA , (no evidence to
recommend one over another), and should be escalated to
two bronchodilators if breathlessness continues with
monotherapy.
If breathlessness is severe, starting the patient on dual
long-acting bronchodilators can be considered, however if
the second therapy does not improve symptoms, the
guidelines suggest stepping down to one bronchodilator.
73. 73
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.
74. 74
Inhaled Steroids in COPD
Exacerbation reduction when
added to LABD in placebo-
controlled trials
Improvement in FEV1 in
combination with beta-
agonists
Clinical trial evidence
o No reduction in COPD
progression
o No mortality reduction
Side effect profile
o Risk of pneumonia
o Risk of osteoporosis, adrenal
suppression
o Hoarse voice
o Oral Thrush
ConsPros
Burge PS, et al. BMJ. 2000;320(7245):1297-1303.
Calverley PM, et al. NEJM. 2007;356:775-789.
Festic E, et al. AJRCCM. 2015;191:141-148.
Kaplan AG. Int J COPD. 2015;10:2535-2548.
Suissa S, et al. Eur Resp J. 2015;46:1232-1235.
75. 75
Risk of patients with COPD developing serious pneumonia is
particularly elevated and dose-dependent with fluticasone
propionate use, and comparatively much lower with
budesonide.
Based on the latest EMA review on ICS for COPD overall the
benefits of inhaled corticosteroid medicines in treating COPD
continue to outweigh their risks
80. 80
Group D
LAMA LAMA + LABA LABA + ICS
LAMA
+ LABA
+ ICS
Consider Roflumilast
if FEV1 50% pred.˂
And patient has
chronic bronchitis
Consider macrolides in
former smokers
Further exacerbation(s)
Further exacerbation(s)
Persistent
Symptoms / further
exacerbation(s)
81. 81
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.
82. 82
The GOLD Report also reinforces the role of ICS/LABA for
patients that have asthma features and/or high blood
eosinophil count, and patients who show more frequent
exacerbations.
For the first time the GOLD Report recognises eosinophils as
a potential decision-driver for COPD treatment and
as a biomarker for risk of exacerbations and identifying ICS
responders
83. 83
In patients who develop further exacerbations on
LABA/LAMA therapy we suggest two alternative
pathways:
1.Escalation to LABA/LAMA/ICS (Triple therapy).
2.Switch to LABA/ ICS
If LABA/ICS therapy does not positively impact
exacerbations/symptoms a LAMA can be added.
85. 85
• For patients who still have exacerbations with
LABA/LAMA/ICS, the following three options can be
considered:
• 1) adding roflumilast (for patients with FEV1<50% predicted
and chronic bronchitis)
• 2) adding a macrolide (azithromycin preferred, however,
antibiotic resistance should be factored in decision-
making)
• 3) discontinuing ICS.
91. 91
The Role of Inhaled Steroids in COPD
Pharmacotherapy
There is no advantage in adding ICS to bronchodilator
therapy in patients at low risk of exacerbations .
Early observational studies suggested that simply stopping
therapy increased the risk of exacerbations. However more
recent data suggest that this may not be true if the patient is
receiving long-acting inhaled bronchodilators .
95. 95
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
treatment
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
WISDOM: Study design
100. 100
Triple therapy may be over used in COPD patients today so ,
Constant evaluation of COPD patients and changes in
patient status over time is essential to good patient care
Step down therapy, by stopping ICS use in patients on
triple therapy , may be considered under the right set of
conditions in selected patients
Patients undergoing treatment step down require close
monitoring to insure no adverse effects over time,
especially COPD exacerbations, are associated with the
change in therapy.
102. 102
Bronchodilators
Continue , stop or
try alternative
class of
bronchodilators
Evaluate effect
Group A
Group B
A long – acting bronchodilators
( LABA or LAMA )
LAMA + LABA
Persistent
Symptoms
Group C
LAMA
LAMA + LABA LABA + ICS
Further
exacerbation(s)
Group D
LAMA LAMA + LABA LABA + ICS
LAMA
+ LABA
+ ICS
Consider Roflumilast
if FEV1 50% pred.˂
And patient has
chronic bronchitis
Consider
macrolides in
former smokers
Further exacerbation(s)
Further
exacerbation(s)
Persistent
Symptoms / further
exacerbation(s)
104. 104
Treatment recommendations are tailored to patient needs
based only on symptoms and exacerbation history.
For patients with only occasional symptoms, a short acting
bronchodilator, either a short-acting beta-agonist (SABA)
or a short-acting muscarinic antagonist (SAMA) is
recommended.
105. 105
For patients with persistent symptoms, either a (LABA) or a
(LAMA) is recommended.
For patients with persistent symptoms on single bronchodilator
therapy, advancement to dual therapy with a LAMA plus a
LABA, or combination ICS/LABA is recommended, with a
preference given to dual-bronchodilator therapy.
106. 106
ICS are not recommended as monotherapy in COPD .
ICS-containing pharmaceutical regimens no longer
recommended as first-choice treatments for COPD of any
severity .
Combination agents containing ICS + LABA are considered
appropriate step-up therapy for patients experiencing COPD
exacerbations while taking long-acting bronchodilators.
107. 107
The new GOLD Strategy provides clear guidance on when
and in which patients ICS can be added or withdrawn.
Only those who have ≥2 exacerbations/year or ≥1 leading to
hospital admission may be considered for an ICS containing
therapy after LAMA/LABA.
In addition, the new GOLD Strategy suggests that ICS therapy
may be withdrawn safely (de-escalation path ) in people with
COPD who are in GOLD group D and stable, by using a
LAMA/LABA regimen.
108. 108
The updated 2017 GOLD Strategy now positions a combination
of a LAMA (long-acting muscarinic receptor antagonists ) and
a LABA (long-acting beta2-agonist), as a mainstay treatment
for people with COPD in GOLD groups B-D.
This represents a significant change versus previous GOLD
guidelines.
109. 109
The GOLD Report acknowledges the potential benefits of
escalation to triple therapy for those patients who are still
exacerbating despite a LAMA/LABA or still symptomatic on
ICS/LABA .
The GOLD Report now mentions roflumilast ( PDE-4
inhibitor ) as an additional treatment option on top of
triple therapy in patients with FEV1 <50% predicted and
chronic bronchitis who still have exacerbations .
110. 110
Inhaled bronchodilators preferred over oral bronchodilators
(A)
Theophylline not recommended; only to be used if other long-
term treatments are not available or unaffordable (B)
112. 112
LAMA/LABA therapy now an essential cornerstone for
COPD treatment across the spectrum of people with COPD
in GOLD groups B-D
Clearer guidance for physicians on which subset of
patients may benefit from the addition of ICS
The Winner of GOLD 2017
113. 113
GOLD 2017 represents a big win for makers of the next-
generation LAMA+LABA combination inhaler treatments.
Once-daily combination inhalers for COPD will likely result
in better adherence, which could result in improved health
outcomes compared to those regimens requiring multiple
devices .
114. 114
The newest COPD combination inhalers aren't on all
formularies and will be out of financial reach for many
patients .
The 2017 GOLD guidelines emphasizing:
The choice of inhaler device has to be individually tailored
and will depend on access, cost, prescriber, and most
importantly the patient's ability and preference .
In other words, the best inhaler for COPD is the one a
patient can afford, understands, agrees with and will use
regularly.
