COPD Translating Guidelines into Clinical Pracice part 2

4
Learning the COPD Guidelines by
Case Studies

 A 68-year-old man was given a diagnosis of COPD year
ago, and his symptoms have been managed with an
albuterol inhaler as needed since.
 Recent spirometry found an FEV1/FVC less than 0.70 and
FEV1 of 65%.
 Last week, he was discharged from the hospital after his
first COPD exacerbation. His mMRC score is currently 1
6

Which COPD patient group is most appropriate
for this patient?
1) Group A
2) Group B
3) Group C
4) Group D
7

Which COPD patient group is most appropriate
for this patient?
1) Group A
2) Group B
3) Group C
4) Group D
8

Scenario
Step 1: assess mMRC or CAT. mMRC=1
– Left side, Less symptoms
Step 2: assess exacerbation hx = 1
(hospitalization)
– Upper side, High risk
– Assessment Score = C

 When identifying the correct patient group category,
patients should be classified according to their worst
symptom.
 mMRC score of 1 would qualify for either patient
group A or C.
 However, if patients have had more than 1
exacerbation or at least 1 exacerbation leading to a
hospitalization in the past 12 months, they would fit
into group C or D.
10
Answer: Group C

Which is the most appropriate treatment
for this COPD patient?
1) Continue albuterol as needed; add Tiotropium.
2) Continue albuterol as needed; add Formoterol.
3) Continue albuterol as needed; add Ipratropium
bromide daily.
4) Continue albuterol as needed; add fluticasone
furoate / vilanterol daily.
12

Which is the most appropriate treatment
for this COPD patient?
1) Continue albuterol as needed; add Tiotropium.
2) Continue albuterol as needed; add Formoterol.
3) Continue albuterol as needed; add Ipratropium
bromide daily.
4) Continue albuterol as needed; add fluticasone
furoate / vilanterol daily.
13

16
 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.

17
Long-Acting Bronchodilators
• LAMAs
• Block acetylcholine-
mediated
bronchoconstriction (via
M3 receptors)
– Tiotropium
– Aclidinium
– Glycopyrronium
(glycopyrrolate
)
– Umeclidinium
• LABAs
• Direct relaxant
activity on airway
smooth muscle (via β2
adrenoceptors)
– Formoterol
– Salmeterol
– Indacaterol
– Oldaterol
– Vilanterol

All of the following LABA/LAMA combination
inhalers for COPD can be Used once daily
except?
A) Indacaterol/ glycopyrrolate
B) Tiotropium/ olodaterol
C) Umeclidinium/ vilanterol
D) Formoterol/aclidinium
18

All of the following LABA/LAMA combination
inhalers for COPD can be Used once daily
except?
A) Indacaterol/ glycopyrrolate
B) Tiotropium/ olodaterol
C) Umeclidinium/ vilanterol
D) Formoterol/aclidinium
19

20
Fixed-dose
combination
LABA/LAMA
DPI Ellipta Anoro®
(vilanterol/umeclidiniu
m)
DPI Breezhaler Ultibro®
(indacaterol/glycopyrr
onium)
SMI Respimat Inspiolto®
(olodaterol/tiotropium
)
DPI Genuair Duaklir®
(formoterol/aclidinium
)
Combination LABA/LAMA inhalers for COPD

For many years, Spiriva had a monopoly on the long-acting anti-
muscaric market but now, there are additional competitors.
The newest products are the combined long-acting muscarinic
antagonists and long-acting beta agonists (LAMA/LABAs).
Although these can be prescribed individually as a LAMA inhaler plus a
second LABA inhaler, the combination inhalers are less expensive than
purchasing the LAMA plus LABA individually.
29

Children’s Healthcare of Atlanta

31
ICS/LABA
DPI Diskus Advair®
(Fluticasone/salmete
rol)
DPI Turbuhaler Symbicort®
(Budesonide/formote
rol)
DPI Ellipta Relvar®
(Fluticasone/vilanter
ol)

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:
– Pneumonia1-6
– Bone density decline and fractures7-10
– Candidiasis and skin lesions6,11,12
– Cataracts13
• Evidence linking ICS-containing therapies
with increased risk of diabetes mellitus14,151. Calverley PM, et al. N Engl J Med. 2007;356:775-789. 2. Crim C, et al. Eur Respir J. 2009;34:641-647;
3. Drummond MB, et al. JAMA. 2008;300:2407-2416;
4. Rodrigo GJ, et al. Chest. 2009;136:1029-1038. 5. Singh S, Loke YK. Curr Opin Pulm Med. 2010;16:118-122;
6. Yang IA, et al. Cochrane Database Syst Rev. 2012;7:CD002991. 7. Lung Health Study Research Group. N Engl J Med. 2000;343:1902-1909;
8. Scanlon PD, et al. Am J Respir Crit Care Med. 2004;170:1302-1309. 9. Hubbard R, et al. Chest. 2006;130:1082-1088;
10. Loke YK, et al. Thorax. 2011;66:699-708. 11. Alsaeedi A, et al. Am J Med. 2002;113:59-65;
12. Mahler DA, et al. Am J Respir Crit Care Med. 2002;166:1084-1091;
13. Weatherall M, et al. Respirology. 2009;14:983-990;
14. O’Byrne PM, et al. Respir Med. 2012;106:1487-1493;
15. Suissa S, et al. Am J Med. 2010;123:1001-1006.
COPD, chronic obstructive pulmonary disease; FDC, fixed-dose combination;
ICS, inhaled corticosteroid; LABA, long-acting β2-agonist

38
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.

39
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 .

Is ICS Withdrawal or Step Down
Therapy Possible in COPD?
40

42
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

45
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
treatme
nt
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

46
WISDOM (Withdrawal of Inhaled
Steroids During Optimised
bronchodilator Management) study

Stepwise withdrawal of ICS was
not associated with an increased
risk of exacerbations
Inhaled glucocorticoid (IGC) = inhaled corticosteroid (ICS).
Magnussen H et al. N Engl J Med 2014;371:1285-94.
IGC
withdrawal
0.0
0.1
0.9
Estimatedprobability
0.2
0.3
0.5
0.4
0.6
0.7
0.8
1.0
0 6 12 18 24 30 36 42 48 54
Weeks to event
Moderate or severe COPD
exacerbation
Hazard ratio 1.06 (95% CI
0.94–1.19)
P = 0.35 by Wald’s chi-square
test
IGC
continuation
Tiotropium+
fluticasone/salmeterol
Tiotropium + salmeterol

48
Stepping Down ICS: A Proposed
Algorithm
Kaplan AG. Int J COPD.
2015;10:2535-2548.

49

A 62-year-old man was recently given a diagnosis of COPD.
Spirometry shows he has a post-bronchodilator FEV1/FVC 60%,
pre-bronchodilator FEV1 70% of predicted, and post-bronchodilator FEV1
72% of predicted.
His symptoms are very bothersome. He reports walking more slowly
than others because of shortness of breath and having to stop to
catch his breath every so often when walking on level ground .
He had 1 exacerbation in the past year that did not require
hospitalization.
51

Which is the most appropriate patient group
classification for him, according to the GOLD
guidelines?
1) Group A
2) Group B
3) Group C
4) Group D 52

Which is the most appropriate patient group
classification for him, according to the GOLD
guidelines?
1) Group A
2) Group B
3) Group C
4) Group D 53

Assessment of Symptoms
• Best way to assess symptoms is to use validated
questionnaires:
– Modified Medical Research Council dyspnea scale. 
MMRC
– COPD Assessment Test  CAT

58
0-1 = less
breathlessness
>2 = more
breathlessness

Scenario
Step 1: assess mMRC or CAT. mMRC=2
– Right side, more symptoms
Step 2: assess exacerbation hx =1 (No
hospitalization)
– Lower side, Low risk
– Assessment Score = B

In addition to albuterol HFA 2 puffs every 4–6
hours as needed, which pharmacotherapy
option is most appropriate to initiate?
1) No additional therapy needed.
2) Formoterol: Inhale contents of 1 capsule twice
daily.
3) Salmeterol/fluticasone 50/500 1 puff twice daily.
4) Salmeterol/fluticasone 50/500 1 puff twice daily
plus roflumilast 500 mcg orally once daily.
63

In addition to albuterol HFA 2 puffs every 4–6
hours as needed, which pharmacotherapy
option is most appropriate to initiate?
A) No additional therapy needed.
B) Formoterol: Inhale contents of 1 capsule twice
daily.
C) Salmeterol/fluticasone 50/500 1 puff twice daily.
D) Salmeterol/fluticasone 50/500 1 puff twice daily
plus roflumilast 500 mcg orally once daily.
64

67
Long-Acting Bronchodilators
• LAMAs
• Block acetylcholine-
mediated
bronchoconstriction (via
M3 receptors)
– Tiotropium
– Aclidinium
– Glycopyrronium
(glycopyrrolate
)
– Umeclidinium
• LABAs
• Direct relaxant
activity on airway
smooth muscle (via β2
adrenoceptors)
– Formoterol
– Salmeterol
– Indacaterol
– Oldaterol
– Vilanterol

68
LAMA
DPI HandiHaler/
SMI Respimat
Spiriva®
(tiotropium)
DPI Breezhaler Seebri®
(glycopyrronium
)
DPI Genuair Eklira®
(aclidinium)
DPI Ellipta Incruse®
(umeclidinium)
LAMA inhalers for COPD

69
LABA
DPI Diskus Serevent®
(salmeterol)
DPI Aerolizer Foradil®
(formoterol)
DPI Breezhaler Onbrez®
(indacaterol)
SMI Respimat Striverdi®
(Olodaterol)
LABA inhalers for COPD

70
 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.

 According to GOLD guidelines,the recommended
treatment for patient group B is regular
treatment with a Long acting bronchodilator (either a
LABA or LAMA), in addition to a Short
acting bronchodilator as needed.
 Answer B is correct as formoterol is a LABA.
 Answers C and D are incorrect as inhaled corticosteroids
are recommended only in groups C and D.
72
Answer: B

(C)
(D)
(A) (B)
LAMA +
LABA
LAMA +
LABA LABA + ICSLABA + ICS
LAMALAMA
Further
exacerbation(s
)
Continue, stop or
try alternative
class of
bronchodilator
Continue, stop or
try alternative
class of
bronchodilator
A bronchodilatorA bronchodilator
Evaluate effect
A long-acting
bronchodilator
(LABA or LAMA)
A long-acting
bronchodilator
(LABA or LAMA)
Persistent
symptoms
LAMA + LABALAMA + LABA
LAMA +
LABA + ICS
LAMA +
LABA + ICS
Further
exacerbation(s)
Further
exacerbation(s)
Consider
roflumilast if FEV1
<50% pred. and
patient has
chronic bronchitis
Consider
roflumilast if FEV1
<50% pred. and
patient has
chronic bronchitis
Consider
macrolid
e (in
former
smokers)
Consider
macrolid
e (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
completel
y
ICS-free
GOLD
Group A
and B
completel
y
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 + LABALAMA + LABA LABA +
ICS
LABA +
ICSLAMALAMA

(C)
(D)
(A) (B)
LAMA +
LABA
LAMA +
LAMALAMA
Further
exacerbation(s
)
Continue, stop or
try alternative
class of
bronchodilator
Continue, stop or
try alternative
class of
bronchodilator
Evaluate effect
A long-acting
bronchodilator
(LABA or LAMA)
A long-acting
bronchodilator
(LABA or LAMA)
Persistent
symptoms
LAMA +
LABA + ICS
LAMA +
LABA + ICS
Further
exacerbation(s)
Further
exacerbation(s)
Consider
roflumilast if FEV1
<50% pred. and
patient has
chronic bronchitis
Consider
roflumilast if FEV1
<50% pred. and
patient has
chronic bronchitis
Consider
macrolid
e (in
former
smokers)
Consider
macrolid
e (in
former
smokers)
Persistent
symptoms/further
exacerbation(s)
Limited role of ICS containing treatment in
Groups C and D
Preferred
treatment
LAMA + LABALAMA + LABA LABA +
ICS
LABA +
ICSLAMALAMA
No
initiation
with ICS
containin
g
treatment
in GOLD
Groups
C and D*
No
initiation
with ICS
containin
g
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.

(C)
(D
)
(A) (B)
LAMA +
LABA
LAMA +
LAMALAMA
Further
exacerbation(s)
Continue, stop or
try alternative
class of
bronchodilator
Continue, stop or
try alternative
class of
bronchodilator
Evaluate effect
A long-acting
bronchodilator
(LABA or LAMA)
A long-acting
bronchodilator
(LABA or LAMA)
Persistent
symptoms
LAMA +
LABA
LAMA +
LABA
LABA +
ICS
LABA +
ICS
LAM
A
LAM
A
LAMA +
LABA + ICS
LAMA +
LABA + ICS
Further
exacerbation(s)
Further
exacerbation(s)
Consider
roflumilast if
FEV1 <50% pred.
and patient has
chronic
bronchitis
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
LAMA/LABA
plays a critical,
central role for
GOLD B-D
LAMA/LABA plays a central role for
GOLD B-D
Consider
macrolid
e (in
former
smokers
)
Consider
macrolid
e (in
former
smokers
)
Consider
roflumilast if FEV1
<50% pred. and
patient has
chronic bronchitis
Consider
roflumilast if FEV1
<50% pred. and
patient has
chronic bronchitis

Additionally, Answer D is incorrect as roflumilast
is recommended only if FEV1 is less than 50%
of predicted with chronic
bronchitis&the patient has a history of
frequent exacerbations.
76

 Linda is a 71-year-old retired executive assistant
who enjoys playing with her grandchildren and
gardening, although lately she has had a lot of
trouble doing both due to shortness of breath.
 She quit smoking 10 years ago and has a 50
pack-year history.
82

She was diagnosed with COPD 8 years ago; she was
placed on a tiotropium HandiHaler once daily and
albuterol HFA as needed.
She recently presented to the emergency department
with persistent dyspnea, cough, and purulent sputum.
She had another exacerbation several months ago .
83

Post-bronchodilator spirometry results for Linda :
FEV1 40%
FEV1/FVC 0.59
Her Modified Medical Research Council (mMRC) score
is currently 3
What would you do next to help improve Linda’s symptoms?
84

According to the GOLD guidelines, which is the
most appropriate course of action?
A) Shift to olodaterol/tiotropium 2 puffs once daily.
B) Add long-term azithromycin 250 mg once daily.
C) Add fluticasone 110 mcg 2 puffs twice daily.
D) Discontinue tiotropium and initiate
salmeterol/fluticasone 250/50 1 puff twice daily.

Scenario
Step 1: assess mMRC or CAT. mMRC= 3
– Right side, more symptoms
Step 2: assess exacerbation hx = 2
– Upper side, High risk
– Assessment Score = D

94
 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.

Linda experiences two more
exacerbations over the next year. Would
you change her treatment?
95

Step-wise treatment for patients with COPD, starting at
the lowest step and then moving up the steps if the
patient’s condition warrants:
Short-acting combination anti-cholinergic plus short-
acting beta agonist should be the initial PRN rescue
inhaler.
A LAMA (long-acting muscarinic antagonist) should be
the first line maintenance therapy.
98

 Once a LAMA is started, the short-acting PRN rescue inhaler
should be changed to a short-acting beta agonist alone (e.g.,
albuterol).
 A LAMA + LABA (long-acting beta agonist) should be the
second line maintenance therapy.
 A LAMA + LABA + ICS (triple therapy) should be the third line
maintenance therapy.
 Inhaled corticosteroid (ICS) alone is not recommended.
99

ICS use increases the risk of pneumonia1-3
ICSs should be avoided in most patients with infrequent
exacerbations (< 1/year)4
Patients with frequent exacerbations (≥ 1/year) may
benefit from ICSs,4 but:
LAMA+LABA therapy is recommended prior to
considering addition of ICS4
Patients with ACOS may benefit from ICS/LABA or
LAMA/LABA/ICS therapy4
Inhaled corticosteroids in COPD
management
ACOS, asthma-COPD overlap syndrome.
1. Suissa et al. Thorax 2013;68:1029-36.
2. Yang et al. Cochrane Database Syst Rev 2012;7:CD002991.
3. Nannini et al. Cochrane Database Syst Rev 2012;9:CD006829.
4. O’Donnell et al. Can Respir J. 2008:15(suppl A):1A-8A.

Care must be taken to exclude ACOS and to
closely monitor symptoms and spirometry if ICS
therapy is tapered and withdrawn
ICS therapy, particularly with fluticasone, is
associated with increased pneumonia risk
ICS dose re-evaluation should be part of COPD
reassessment
Inhaled corticosteroids in COPD
management

10
2
Triple Combo COPD
Inhaler

108
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.

109
 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.

Possible next step from triple therapy
What if she continues to have frequent
exacerbations?
Consider the role of macrolide or PDE4 inhibitor.
111

118
 The newest COPD combination inhalers aren't on all
formularies and will be out of financial reach for many
patients .
 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.

119
 Inhaler technique needs to be assessed regularly to
improve therapeutic outcomes.
 Instructions and demonstration of a proper inhalation
technique are essential also a re-check at each visit to
ensure a correct use of the inhaler.
 Inhaler technique (and adherence) should be
evaluated before a treatment is assessed as
insufficient.

Critical steps in using inhaler
devices correctly

121

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