Ashtma in children and young people - Pharmacological management

Management in children under5 years
Children under 5 years are a particular problem for
asthma management guidelines because the
evidence base is limited or absent.
There are two particular problems at this age,
Firstly, there is a lack of good objective
tests to guide either diagnosis or
management in children under 5 years.
Secondly, the pattern of asthma in preschool
children is heterogeneous and different from adults. 7

 For children under 5 with suspected asthma,
treat symptoms based on observation &
clinical judgement, and review the child on a
regular basis
 If they still have symptoms when they reach 5
years, carry out objective tests
8

 There is no single test that can definitively
diagnose asthma.
 There is currently no gold standard test
available to diagnose asthma;
diagnosis is principally based on a thorough
history taken by an experienced clinician
9

 It can be difficult to confirm asthma diagnosis
in young children, therefore treatment
recommendations apply to children with
suspected or confirmed asthma.
 Asthma diagnosis should be confirmed when
the child is able to undergo objective
tests.
10

12
Pharmacological treatment pathway for children
under 5

Pharmacological treatment pathway for
children under 5
 Offer a SABA as reliever therapy to children <5
years with suspected asthma.
 This should be used for symptom relief
alongside all maintenance therapy.
13

17
 Oral preparations of beta2 agonists have
been used extensively in the past with
children but , are less effective than inhaled
preparations and have more side-
effects

18
The use of albuterol syrup has fallen out of favor over
the past
decade with the advent of better modalities of targeted,
inhaled delivery systems (e.g., MDI with spacer/holding
chamber, nebulizer solution).
AAAAI Guidelines (2004, p88) prefer inhaled beta2-
agonists to oral because higher
concentrations are delivered more effectively to the
airways, the onset of action is substantially shorter, and
systemic side effects can be avoided or minimized.
• Authors concluded lack of updated information was a possible reason that community-
Special Consideration – Albuterol
Syrup

19
 Increasing use of SABA treatment or the use of SABA
> 3 doses a weekforsymptomrelief (not
prevention of EIB) generally indicates inadequate asthma
control and the need forinitiating orintensifying anti-
inflammatory therapy.
 Regularly scheduled, daily, chronic use of SABA
is not recommended.

21
The use of short-acting inhaled beta2-agonists
on a daily basis, orincreasing use, indicates
the need foradditional long termcontrol
therapy.

First-line preventertreatment in children under5
Y with probable asthma and poorsymptom control
:
In young children with symptoms uncontrolled by
intermittent reliever use in whom maintenance therapy is
being considered, regulardaily inhaled corticosteroid is
the first-line preventerof choice.
22

 In these children, NICE recommends an 8-weektrial
of a paediatric moderate dose (‘Trial of treatment’).
 At the end of the 8 weeks, NICE advises stopping
treatment and assessing the response and
subsequent progress.
23

 NICE’s recommendation to start at a paediatric
moderate dose was driven by a need to be
confident whetherornot the symptoms
were responsive to ICS.
24

Consideran 8-weektrial of a paediatric moderate dose
of an ICS in children <5 years with :
Symptoms at presentation that clearly indicate the need for
maintenance therapy (e.g. asthma-related symptoms ≥3 times
a week, orcausing waking at night), OR
Suspected asthma that is uncontrolled with a SABA alone.
25

After8 weeks, stop ICS treatment and continue to
monitorthe child's symptoms:
1)if symptoms did not resolve during the trial period, review
whether an alternative diagnosis is likely,
2)ifsymptomsresolvedthenreoccurredwithin4weeksof
stoppingICStreatment, restarttheICSatapaediatric
lowdoseasfirst-linemaintenancetherapy,
3)ifsymptomsresolvedbutreoccurredbeyond4weeks
afterstoppingICStreatment, repeatthe8-weektrial
ofapaediatricmoderatedoseofICS.
27

1)if symptoms did not resolve during the trial period, review
whether an alternative diagnosis is likely,
2)if symptoms resolved then reoccurred within 4 weeks of
stopping ICS treatment, restart the ICS at a paediatric
low dose as first-line maintenance therapy,
3)if symptoms resolved but reoccurred beyond 4 weeks after
stopping ICS treatment, repeat the 8-week trial
of a paediatric moderate dose of ICS.
28

1)ifsymptomsdidnotresolveduringthetrialperiod,
reviewwhetheranalternativediagnosisislikely,
2)ifsymptomsresolvedthenreoccurredwithin4weeks
ofstoppingICStreatment, restarttheICSatapaediatric
lowdoseasfirst-linemaintenancetherapy,
3)if symptoms resolved but reoccurred beyond 4 weeks after
stopping ICS treatment, repeat the 8-weektrial
of a paediatric moderate dose of ICS.
29

If suspected asthma is uncontrolled in children
under5:
1)on a paediatric low dose of ICS as maintenance therapy,
consideran LTRA* in addition to the ICS.
2)on a paediatric low dose of ICS & LTRA* as maintenance
therapy, stop the LTRA &referthe child to a healthcare
professional with expertise in asthma forfurther
investigation and management.
30

If suspected asthma is uncontrolled in children
under5:
1)on a paediatric low dose of ICS as maintenance therapy,
consider an LTRA* in addition to the ICS.
2)on a paediatric low dose of ICS & LTRA* as maintenance
therapy, stop the LTRA &referthe child to a healthcare
professional with expertise in asthma forfurther
investigation and management.
31

If asthma in children under5 is uncontrolled on
first line preventer, what next?
At this stage, both NICE and BTS/SIGN state that evidence
is very limited.
BTS/SIGN note that long acting bronchodilators are not
licensed under4 years and evidence comparing ICS +
LABA vs ICS + LTRA at this age is absent.
32

36
Pharmacological treatment pathway for children and young people
aged 5 to 16 years

 Offera SABA as relievertherapy to children and young
people (aged 5 to 16 years) with newly diagnosed
asthma
 Forchildren and young people (aged 5 to 16 years)
with asthma who have infrequent, short-lived wheeze
and normal lung function, considertreatment with
SABA relievertherapy alone
40

 Offera paediatric low dose of an ICS as the first-line
maintenance therapy to children and young people
(aged 5 to 16) with:
Symptoms at presentation that clearly indicate the need
for maintenance therapy for example, asthma-related
symptoms 3 times a week or more, or causing waking at
night) or asthma that is uncontrolled with a SABA alone
41

 If asthma is uncontrolled in children and young people
(aged 5 to 16 years) on a paediatric low dose of ICS
as maintenance therapy :
 Consideran LTRA in addition to the ICS and
 Review the response to treatment in 4 to 8 weeks
43

and an LTRA as maintenance therapy :
 Considerstopping the LTRA and starting a LABA in
combination with the ICS
44

and a LABA as maintenance therapy :
 Considerchanging theirICS and LABA maintenance
therapy to a MART regimen with a paediatric low
maintenance ICS dose.
45

(aged 5 to 16 years) on a MART regimenwith a
paediatric low maintenance ICS dose:
 Considerincreasing the ICS to a paediatric moderate
maintenance dose (eithercontinuing on a MART
regimen orchanging to a fixed-dose of an ICS and a
LABA, with a SABA as a relievertherapy)
46

(aged 5 to 16 years) on a paediatric moderate maintenance
ICS dose with LABA (either as MART‡
or a fixed-dose
regimen), consider seeking advice from a healthcare
professional with expertise in asthma and consider either:
1) increasing the ICS dose to paediatric high maintenance dose
(only as part of a fixed-dose regimen, with a SABA used as
a reliever therapy) or
2) a trial of an additional drug (for example, theophylline)
47

(aged 5 to 16 years) on a paediatric moderate maintenance
ICS dose with LABA (either as MART‡
or a fixed-dose
regimen), consider seeking advice from a healthcare
professional with expertise in asthma and consider either:
1) increasing the ICS dose to paediatric high maintenance dose
(only as part of a fixed-dose regimen, with a SABA used as
a reliever therapy) or
2) a trial of an additional drug (for example, theophylline)
48

Inhaled Steroid Initiation
The BTS/SIGN guideline of 2016 moved away from the
traditional first-step of asthma management, by suggesting that
inhaled steroid therapy should be used in all but a small minority
of people with asthma.
The NICE guideline has not followed this trend, and remains
suggestive of the traditional step-one management of short-
acting B2 agonist alone.
50

 The NICE Guideline for the management of asthma, still
advocating the use of SABA alone in its algorithm though
it is noteworthy that the detailed commentary reports this
should only be prescribed for a small minority of patients
 For many, however, this will seem a retrograde step and
has the potential to encourage continued over-reliance
on SABA.
51

54
Asthma management
in children

ICS doses
ICS doses & their pharmacological strengths vary across
different formulations.
In general, people with asthma should use the smallest
doses of ICS that provide optimal control for their asthma, in
order to reduce the risk of side effects.
55

Categorizing inhaled corticosteroids dosing
and potency in children
There are some discrepancies between the NICE and
BTS/SIGN categorisation of inhaled steroid dosages for
children.
NICE have followed the GINA guidelines and define ICS
doses for children as low, moderate and high dose
56

Categorizing inhaled corticosteroids dosing
and potency in children
BTS/SIGN uses very low, low and medium categories
and specifically defines doses of commonly used ICS
preparations.
57

© Global Initiative for Asthma
This is not a table of equivalence
A low daily dose is defined as the dose that has not been associated
with clinically adverse effects in trials that included measures of safety
‘Low dose’ inhaled corticosteroids (mcg/day)
for children ≤5 years
GINA 2017, Box 6-6
Inhaled corticosteroid Low daily dose (mcg(
Beclometasone dipropionate (HFA) 100
Budesonide (pMDI + spacer) 200
Budesonide (nebulizer) 500
Fluticasone propionate (HFA) 100
Ciclesonide 160
Mometasone furoate Not studied below age 4 years
Triamcinolone acetonide Not studied in this age group
GINA 2017, Box 6-6

 For children and young people aged 16 years and under:
less than or equal to 200 micrograms budesonide or
equivalent would be considered a paediatric low dose
 More than 200 micrograms to 400 micrograms budesonide
or equivalent would be considered a paediatric moderate
dose
 More than 400 micrograms budesonide or equivalent would
be considered a paediatric high dose
61

 “Prescribers should be aware that fluticasone propionate
is as effective as other inhaled steroids approximately at
half the microgram daily dose”;
 in line with this BTS/SIGN advise that, to avoid over-
dosage, the dose of fluticasone should be half that of
beclomethasone
 Fluticasone is usually regarded as twice as potent as
beclometasone.
62

63
Beclomethasone
Dipropionate 100
ug/dose
Beclomethasone
Dipropionate 50 ug/dose

 The age ranges used to define a child also differ.
 NICE defines children as under16 years while for
both BTS/SIGN and GINA adolescents over12 years
are considered with adults .
69

70
ICS usage as a preventer therapy should be
explained to the parents in simple, plain
terms.

71
Pharmacokinetics of Inhaled Drugs

ICS forAsthma : Benefits and Risks
BenefitsBenefits
RisksRisks

74
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

80
Aerochamber spacer
With mouth piece
Aerochamber spacer with mask

Inhalerdevices
Choosing and using an inhaled device is a critical part
of managing asthma, particularly for children.
NICE acknowledges suboptimal inhaler technique as a
possible reason for uncontrolled asthma and advises
that inhaler technique should be observed and checked
at every consultation.
81

Age group Preferred device Alternative device
Youngerthan 4 years
Pressurized metered-dose
inhaler plus dedicated
spacer with face mask
Nebulizer with face mask
4-5 years
Pressurized metered-dose
inhaler plus dedicated
spacer with mouthpiece
Nebulizer with mouthpiece
Older than 6 years
Dry powder inhaler or breath
actuated pressurized metered-
dose inhaler or pressurized
metered-dose inhaler with
spacer with mouthpiece
Nebulizer with mouthpiece
Choosing an inhalerdevice forchildren with asthma

88
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

89
Fate of inhaled drugs – Good Technique
Swallowed
GI tract
Deposited in lung
Lungs
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
Adapted from Barnes et al. AJRCCM 1998;157:S1-S53
Swallowed
GI tract
Deposited in lung
Lungs
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
Fate of inhaled drugs – Poor Technique

90
 Inhaled medications is a waste of money if not used properly
 Poortechnique is a barrierto good athma control
 Checkat each visit
 Don’t rely on patient’s knowledge – askthemto demonstrate

93
If inhaled corticosteroid (ICS) maintenance therapy is needed,
offer regular daily ICS rather than intermittent or when required
ICS therapy.
Consider decreasing maintenance therapy when a person’s
asthma has been controlled with their current maintenance
therapy for at least 3 months.

Leukotriene receptorantagonists
The most controversial element of the NICE asthma
guidelines is the suggestion that Leukotriene receptor
antagonists (LTRA) should be used BEFORE using
Long Acting B2 agonists (LABA).
94

Both NICE and BTS/SIGN recommend an LTRA in
combination with low dose ICS as the next step.
If that fails, NICE suggest stopping the LTRA & referring
to a clinician with expertise in asthma.
101

At this stage, both NICE and BTS/SIGN state that evidence
is very limited.
BTS/SIGN note that long acting bronchodilators are not
licensed under4 years and evidence comparing ICS +
LABA vs ICS + LTRA at this age is absent.
102

as maintenance therapy :
 Consideran LTRA in addition to the ICS and
 Review the response to treatment in 4 to 8 weeks
103

 Adding LABA therapy to existing inhaled steroid therapy
has been shown to be more clinically effective than
adding LTRA therapy to inhaled steroid.
 However, LTRA therapy is cheaper than LABA therapy,
and as such is the reason for its inclusion in the NICE
guidelines.
104

BTS/SIGN continue the long-held view that low dose ICS
should be followed by addition of long-acting beta-
agonists (LABA) in line with international guidelines such
as the Global Initiative for Asthma (GINA)

Head to head comparisons of ICS/LABA compared to
ICS/LTRA have favoured ICS/LABA for effectiveness in
adults (inconclusive in children).
105

 On a practical level, it may be easier to move from an
inhaled steroid to an ICS/LABA combination by the
simple change of an inhaler.
 Whereas the addition of an extra medication in the
form of a tablet that is taken at night, may reduce
adherence.
106

On a practical level, an increase in therapy from ICS
alone to ICS/LABA, in most cases, only requires the
name of the inhaler to be changed; the patient just
continues using one inhaler as their preventer.
Indeed, in the case of single maintenance and reliever
therapy (MART), a single inhaler may be all that is
required.
107

 The choice for clinicians will be prescribing LABA in
a combination inhaler as the more effective first line
add-on therapy (BTS/SIGN) or
 adopting the NICE strategy of trying the cheaper
option of a LTRA which will be cost-effective for those
in whom it works.
108

Combination Medications
Combination
Medications
ICS LABA
Symbicort®
Budesonide
(Pumicort®)
Formoterol
(Oxeze®)
Seretide®
Fluticasone
(Floxitide®)
Salmeterol
(Severent®)

113
 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

Children’s Healthcare of Atlanta
 Recent data indicating a possible increased riskof
asthma Related death associated with use of LABA in
a small group of individuals has resulted in increased
emphasis on the message that:
 LABA should not be used as monotherapy in asthma
& must only be used in combination with an
appropriate dose of ICS.

116
 In clinical practice, however, it is generally considered
that combination inhalers (ICS & LABA) aid adherence
and also have the advantage of guaranteeing that the
LABA is not taken without the ICS

Beyond combination therapy
NICE recommends a MART (Maintenance & Reliever
Therapy) regimen for people with asthma “uncontrolled
on a low dose of ICS/LABA, with or without an LTRA” .
The NICE guideline recommends considering MART
regimen in children and young people aged 5 to 16 .
118

BTS/SIGN advises considering a MART regimen for
patients ‘who have a history of asthma attacks on
medium dose ICS or ICS/LABA’.
BTS/SIGN, does not make a recommendation for use
of MART in children.
119

 According to BTS/SIGN, Maintenance and Reliever
Therapies (MART) are mainly prescribed to adults (aged
18 or over).
 But some children over 12 may sometimes be prescribed
a Symbicort MART inhaler on the MART regime, when
their asthma is not well controlled.
120

Common brands in the UKinclude:
1.Symbicort MART Regime (also known as SMART)
2.FostairMART Regime
121
 Not everyone using a combination inhaler is on
a MART regime.

fast onset, short duration fast onset, long duration
slow onset, short duration slow onset, long
duration
inhaled terbutaline
inhaled salbutamol
inhaled formoterol
oral terbutaline
oral salbutamol inhaled salmeterol
oral bambuterol
M
A
I
N
T
E
N
A
N
C
E
AS NEEDED
Duration
of actionlongShort
Classes of β2-agonists
Speed
of action
Fast
Slow

Maintenance and RelieverTherapy (MART)
Maintenance &reliever therapy (MART) is a form of combined
ICS and LABA treatment in which a single inhaler, containing
both ICS And a fast-acting LABA, is used for both daily
maintenance therapy and the relief of symptoms as required.
MART is only available forICS and LABA combinations in
which the LABA has a fast-acting component (for example,
formoterol) within one to three minutes of inhalation .
123

 Budesonide/formoterol combination products
,Symbicort are licensed for use as SMART therapy
 Beclometasone/formoterol combination inhaler, Fostair,
has also recently been licensed for use as MART
therapy
 Both combinations of ICS and LABA are suitable for use
as maintenance and reliever therapy as they contain the
LABA formoterol.
126

Poor
asthma
control
Optimal
asthma
control
Time
(months, weeks, days)
Combination Strategy : Traditional approach
SABA
ICS
+
LABA

129
+or
Traditional approachTraditional approach
Maintenance dose + as needed SABAMaintenance dose + as needed SABA

Symbicort SMART
Symbicort Maintenance And Reliever Therapy
Formoterol
Budesonide
SABASABA

As needed
β2
As needed
Symbicort
Dailymedicationuse
(maintenanceandrelief)
Traditional Approach
Fixed Symbicort
+ prn SABA
TRADITIONAL APPROACH AND SYMBICORT
MAINTENANCE AND RELIEVER THERAPY
(SMART)
Days with symptoms
Maintenance
Symbicort
SMART
Maintenance
Time
Most days patients
use no reliever
illustrativeillustrative

Total daily medication use
(maintenance and relief)
Fixed Symbicort
+ prn SABA
Fixed Symbicort
+ prn Symbicort
(Symbicort SMART)
If a combination inhaler containing formoterol and budesonide is
selected, it may be used for both rescue and maintenance. This
approach has been shown to result in reductions in exacerbations and
improvements in asthma control in adults and adolescents at relatively
low doses of treatment (Evidence A) … page60 GINA 2007

Dosing
The maximum daily dose of formoterol is 72μg, which limits
the number of inhalations that can be used in a single day.
Symbicort SMART regimens use the 6μg formulations
(200/6 or100/6).
Symbicort inhalers containing 12μg are not licensed for
use as SMART (Symbicort 400/12 is not suitable for the
SMART regimen).
137

Dosing
Fostair 100/6 contains 6μg of formoterol and can be
prescribed as 100/6 two puffs daily in two divided doses for
maintenance with up to six additional puffs daily as required
for relief of symptoms.
The highest dose Symbicort inhaler (400/12) is not included
in SMART due to the risk of supra-therapeutic doses.
138

 Combination inhalers of salmeterol with an ICS, such
as Seretide, are not suitable forsingle inhaler
maintenance and relievertherapy.
 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.
139

 Not all combination products are licenced for maintenance
and reliever therapy.
 At present maintenance and reliever therapy (MART) is
only licenced for use with budesonide/ formoterol or
beclomethasone/formoterol in adults overthe age of 18.
 Patients taking rescue doses of their combination inhaler
once a day ormore on a regularbasis should have their
treatment reviewed , as this would suggest that their
asthma control is sub-optimal.
140

Product choice
Symbicort uses a Turbohaler device, Fostair is delivered
via a metered-dose inhaler (MDI).
The MDI is compatible with spacer devices.
Patient preference for different inhaler devices and
competence at using the device will influence choice .
141

142
 Long-acting beta2 agonists are currently overprescribed in
children. They are also often used inappropriately as first-
line therapy and are not recommended forchildren aged
five years orless.
Due to the paucity of paediatric clinical trials, the evidence
for the efficacy and safety of long-acting beta2agonists in
children is limited.

144
Asthma management
in children

145
Asthma management
in children

© Global Initiative for Asthma
Step 3 (children ≤5 years) – mediumdose ICS
+ as-needed inhaled SABA
GINA 2017, Box 6-5 (7/8)
Infrequent
viral wheezing
and no or
few interval
symptoms
Symptom pattern consistent with asthma
and asthma symptoms not well-controlled, or
≥3 exacerbations per year
Symptom pattern not consistent with asthma but
wheezing episodes occur frequently, e.g. every
6–8 weeks.
Give diagnostic trial for 3 months.
Asthma diagnosis, and
not well-controlled on
low dose ICS
Not well-
controlled
on double
ICS
First check diagnosis, inhaler skills,
adherence, exposures
CONSIDER
THIS STEP FOR
CHILDREN WITH:
RELIEVER
Other
controller
options
PREFERRED
CONTROLLER
CHOICE
As-needed short-acting beta2-agonist (all children)
Leukotriene receptor antagonist (LTRA)
Intermittent ICS
Low dose ICS + LTRA Add LTRA
Inc. ICS
frequency
Add intermitt
ICS
Daily low dose ICS
Double
‘low dose’
ICS
Continue
controller
& refer for
specialist
assessment
STEP 1 STEP 2
STEP 3
STEP 4

147
Asthma and Respiratory Foundation NZ child &
adolescent asthma guidelines -1st December2017
LABAs should not be used in children ≤4 years
of age.

 Oral preparations of beta2 agonists have been
used extensively in the past with children but are
less effective than inhaled preparations and have
more side-effects
148

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