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Pharmacological Management of
Asthma
Ellen Nicholson
Queens Nurse
City & Hackney GP Confederation
November 2016
DISCLAIMER: The views and opinions expressed in this presentation are those of the authors and do not necessarily
represent the views and policy of PLAN(Pan London Airways Network).
WHAT THIS PRESENTATION COVERS
Background
Key priorities
Discussion
DECLARATIONS OF INTEREST
Received education for professional advisory boards/speaking from Teva,
Boehringer Ingelheim and Novartis
Committee member of NICE Asthma Management Guidelines consultation
publication 19/12/2016
Member of Association of Respiratory Nurse Specialists and Primary Care
Respiratory Society
NATIONAL REVIEW OF ASTHMA
DEATHS (NRAD)
C O N F I D E N T I A L E N Q U I R Y I N T O > 2 0 0 A S T H M A - R E L A T E D D E A T H S
K E Y F I N D I N G S I N C L U D E D :
F R E Q U E N T S U B - O P T I M A L I C S / P O S T E R O I D T R E A T M E N T
E X C E S S I V E U S E O F S A B A
L A C K O F R E F E R R A L T O S P E C I A L I S T S E R V I C E S
P O O R L Y R E C O R D E D P U L M O N A R Y F U N C T I O N T E S T S W I T H I N T H E
C O M M U N I T Y
G E N E R A L L A C K O F P A A P U S E
Levy et al., 2014
Presentation with respiratory symptoms: wheeze, cough, breathlessness, chest tightness 1
High probability
of asthma
Code as:
suspected asthma
Initiation of
treatment
Assess response
objectively
lung function/(
validated symptom
score)
Good response
Asthma
Adjust maintenance
dose. Provide self-
management
Arrange on-going
review
Intermediate probability of asthma
Test for airway obstruction
spirometry + bronchodilator reversibility
Suspected asthma:
Watchful waiting (if
asymptomatic)
or
Commence treatment
assess response objectively
Good
response
Other diagnosis
confirmed
Investigate/treat for
other more likely
diagnosis
Other diagnosis
unlikely
Low probability of
asthma
Poor
response
Poor
response
Options for investigations are:
Test for variability:
• reversibility
• PEF charting
• challenge tests
Test for eosinophilic
inflammation or
atopy:
• FeNO
• blood eosinophils,
• skin-prick test, IgE
Structured clinical assessment (from history and examination of previous medical records) Look for:
 recurrent episodes of symptoms  recorded observation of wheeze
 symptom variability  personal history of atopy
 absence of symptoms of alternative diagnosis  historical record of variable PEF or FEV
1
Pharmacological
Management
APPROACH TO MANAGEMENT
Start treatment at the level most appropriate to initial severity.
Achieve early control.
Maintain control by:
increasing treatment as necessary
decreasing treatment when control is good.
NEW BTS GUIDELINES
Stepwise approach
replaced by regular
preventer and add
on approach.
This highlights short
acting beta2
agonists are key
‘rescue therapy’
from symptoms or
asthma attacks but
should rarely be
used on their own
BTS GUIDELINES
High probability of
asthma: start
initiation of
treatment (typically
6 weeks of inhaled
corticosteroids)
Reasses with a
validated symptom
questionnaire
and/or lung function
tests (FEV1 or home
serial peak flows
Good symptomatic
response to treatment -
confirm diagnosis of
asthma
Record how the
diagnosis was made
Poor response or
equivocal, check
inhaler technique and
adherence, arrange
further tests and
consider alternative
diagnoses.
INTERMEDIATE PROBABILITY OF ASTHMA
Spirometry, with
bronchodilator
reversibility is
preferred test
Initiate treatment
and assess the
response by
repeating lung
function tests and
objective
measures of
asthma control.
In adults and
children with an
intermediate
probability of
asthma and
normal
spirometry
results;
Challenge tests
FeNO to identify
eosinophilic
inflammation.
E O S I N O P H I L S
Elevated sputum eosinophil
predict asthma exacerbations
and responsiveness to ICS.
Patients with blood eosinophil
counts greater than 400 cells
per μL experience have more
severe exacerbations and have
poorer asthma control.
Price et al (2016) UK Cohort Study
F E N O
Raised eosinophil counts
and exhaled nitric oxide
(FeNO) are biomarkers of
Th2 immune responses
FeNo value in patient >12 years
Low <20 ppb
Intermediate 20-50 ppb
High > 50 ppb
In case of >40 ppb increase from
previous stable levels interpret as
high
Schneider (2015) et al
LOW PROBABILITY
If there is a low probability
of asthma and/or an
alternative diagnosis is
more likely, investigate
for the alternative
diagnosis and/or
undertake or refer for
further tests of asthma.
BTS 2016
SHORT ACTING ß2 AGONISTS
 Side Effects:
Fine tremor
Tachycardia
Hypokalaemia
Restlessness
Hypoxaemia
 Cautions:
Hyperthyroidism
Cardiovascular disease
Arrhythmias
Susceptibility to QT-interval
prolongation
Hypertension
Alleviate breathlessness
by their direct affect on the
airway by relaxing smooth
muscle
But they also:
↓ pulmonary
hyperinflation
↑ mucociliary clearance
Improve respiratory
muscle function
BTS 2016
CHOICE
Choice of drug (s) should take into account
person’s
- Preference to device
- Symptomatic response
- Ability to use the inhaler device effectively
- Drugs potential to reduce exacerbations
- Minimise side effects
- Cost
INHALER TECHNIQUE
 Optimal inhaled particle deposition
 requires a forceful inhalation for DPIs and a gentle inhalation for pMDI
inhalers
Bud60 Bud35
0
10
20
30
40
50
% Lung Deposition
Insp Flow l/min
Lung deposition of budesonide inhaled via
Turbuhaler®: a comparison with terbutaline
sulphate in normal subjects.
Borgstrom et al. 1994
Acknowledgement Paul Pfeffer
INHALED CORTICOSTEROIDS
Supress inflammatory/immunological responses & mitigate against airway hyper-
responsiveness
It takes 1-4 weeks before the benefit of Introducing/up-titrating ICS is apparent
A high level of drug deposits within the mouth and throat
Oral candidiasis occurs as a consequence of this. Rinsing the mouth after may
reduce the risk of oral opportunistic infection
Battaglia et al., 2014
BTS emphasise preventer medication to minimise future asthma attacks
Add on therapy recommend combination inhaler (ICS/LABA)
If a patient has poor control of their asthma, it is essential to check whether they
are using their current drug treatment correctly and regularly, before stepping up
treatment
LEUKOTRIENE RECEPTOR AGONISTS
Leukotrienes are inflammatory mediators produced by leukocytes which
contribute to bronchospasm and airway hyper-responsiveness
BTS recommend as add on therapy after Combination inhaler
Example drugs include: Montelukast, Zafirlukast
ICS & LABA COMBINATIONS
MAINTENANCE AND RELIEVER THERAPIES
(MART)
Maintenance and Reliever
Therapies are designed
for adults (aged 18 or
over).
Evidence suggests MART
reduces exacerbations,
hospitalisation and
SABA use
Symbicort SMART
Regime
Fostair MART Regime
DuoResp Spiromax
MART Regime.
pMDI DPI OD MART
Step 1
Step 2/3
Step 3/4
‘Inhaler Tree’ – Acknowledgement to Dr. Paul Pfeffer
MULTIPLE INHALERS CONFUSE
ASTHMA PATIENTS
Study of 208
patients with a
single inhaler type
and
113 with multiple
inhaler types.
29% error rate in
patients with a
single inhaler type
39% of patients with
multiple inhaler
types made
significant errors.
32% error rate in
patients with
multiple DPI
types.
46% error rate in
patients with a
pMDI and a DPI
van der Palen et al. ERJ 1999
Theophylline family of drugs e.g.
Aminophylline, Theophylline, Phyllocontin
Continus (SR)
Inhibits the phosphodiesterase enzyme
causing relaxation of the bronchial smooth
muscle and bronchodilation
Narrow therapeutic window – readily toxic
(requires monitoring). Slow release drugs
may be prescribed to treat poorly controlled
asthma (step 4)
Can be administered intravenously to
terminate acute bronchospasms refractory to
nebulised bronchodilators
METHYLAXANTHINES
MUSCARINIC ANTAGONIST
Onset of action is slower
than ß2 agonists
 Approx 30mins
Bronchodilator effects
longer
Side effects:
 Dry mouth
 Blurred vision
 Paradoxical bronchospasm
 Glaucoma – care with
nebulisers
T I O T R O P I U M R E S P I M A T
( S P I R I V A ® )Once daily LAMA
Indication:
maintenance
bronchodilator in
adult patients with
asthma
Dose: 2.5mcg TT puffs
BD
Omalizumab
Indicated as an add
on therapy to
improve asthma
control in adult and
adolescent patients
(12 years and above)
with severe
persistent allergic
asthma which is not
controlled on
optimised BTS step
5 therapy
NICE Technology appraisal (TA278) April 2013
Mepilizumab
A targeted anti IL-5
therapy for adult
patients with severe
refractory
eosinophilic asthma
Humanised
monoclonal antibody
which inhibits the
bioactivity of the
cytokine interleukin
(IL-5)
FEVIPIPRANT
Between 2012 and 2013,
study carried out by
University of
Leicester/University of
Oxford in the UK, and
Novartis in
Switzerland.
RCT 61 participants
received either
fevipiprant tablets
225mg bd or a placebo
for 12 weeks.
Fevipiprant gave
greater reduction in
eosinophil count
compared with
placebo.
Mean percentage of
eosinophils in
sputum decreased
from 5.4% to 1.1%. It
decreased in the
placebo group from
4.6% to 3.9%.
Gonem et al 2016. Lancet Volume 4. No 9,
p699–707, September 2016
MONITORING AND FOLLOW UP
Flo-tone device
In-check
dial
PERSONAL ASTHMA ACTION PLAN (PAAP)
PAAP & ASTHMA REVIEW
Triggers should be
documented in
patient notes and on
asthma action plan
Each review should
review asthma control
(asthma control test
etc.)
Ring et al., 2011
Gibson & Powell, 2004
Newell et al. 2015
Inhaler techniques
should be routinely
undertaken
Non-adherence should
be identified and
monitored
Urgent review for all
with more than 12
short-acting beta
agonist inhalers in
previous 12 months
WEIGHT LOSS
Weight loss initiatives – including dietary and exercise programmes – can
be offered for overweight or obese adults and children with asthma and
may improve their asthma control
PREGNANCY
Women with asthma who are pregnant should be informed of the
importance of continuing their asthma medication during pregnancy for
the health of both mother and baby
LONG ACTING ß2 AGONISTS
The Asthma UK report published
in June 2015 ‘Patient safety
failures in asthma: the scale of
unsafe prescribing in the UK’
identified
22,840 people prescribed a
LABA or LAMA without ICS
106,742 people prescribed more
than 12 short-acting
bronchodilators a year
Representing 0.4% and
2% respectively of the total 5.4
million people receiving
treatment for asthma.
It is dangerous to use a
long-acting reliever inhaler
without a steroid preventer
inhaler
ASTHMA DISCHARGE BUNDLE
SUMMARY
Use inhaler device that patient is able to use
Try to avoid generic prescribing
Consider if diagnosis is correct if treatment is not reducing side effects or
onwards referral
Everyone with an asthma diagnosis should have a PAAP
THANK-YOU &
QUESTIONS

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Pharmacological Management of Asthma

  • 1. Pharmacological Management of Asthma Ellen Nicholson Queens Nurse City & Hackney GP Confederation November 2016 DISCLAIMER: The views and opinions expressed in this presentation are those of the authors and do not necessarily represent the views and policy of PLAN(Pan London Airways Network).
  • 2. WHAT THIS PRESENTATION COVERS Background Key priorities Discussion
  • 3. DECLARATIONS OF INTEREST Received education for professional advisory boards/speaking from Teva, Boehringer Ingelheim and Novartis Committee member of NICE Asthma Management Guidelines consultation publication 19/12/2016 Member of Association of Respiratory Nurse Specialists and Primary Care Respiratory Society
  • 4. NATIONAL REVIEW OF ASTHMA DEATHS (NRAD) C O N F I D E N T I A L E N Q U I R Y I N T O > 2 0 0 A S T H M A - R E L A T E D D E A T H S K E Y F I N D I N G S I N C L U D E D : F R E Q U E N T S U B - O P T I M A L I C S / P O S T E R O I D T R E A T M E N T E X C E S S I V E U S E O F S A B A L A C K O F R E F E R R A L T O S P E C I A L I S T S E R V I C E S P O O R L Y R E C O R D E D P U L M O N A R Y F U N C T I O N T E S T S W I T H I N T H E C O M M U N I T Y G E N E R A L L A C K O F P A A P U S E Levy et al., 2014
  • 5. Presentation with respiratory symptoms: wheeze, cough, breathlessness, chest tightness 1 High probability of asthma Code as: suspected asthma Initiation of treatment Assess response objectively lung function/( validated symptom score) Good response Asthma Adjust maintenance dose. Provide self- management Arrange on-going review Intermediate probability of asthma Test for airway obstruction spirometry + bronchodilator reversibility Suspected asthma: Watchful waiting (if asymptomatic) or Commence treatment assess response objectively Good response Other diagnosis confirmed Investigate/treat for other more likely diagnosis Other diagnosis unlikely Low probability of asthma Poor response Poor response Options for investigations are: Test for variability: • reversibility • PEF charting • challenge tests Test for eosinophilic inflammation or atopy: • FeNO • blood eosinophils, • skin-prick test, IgE Structured clinical assessment (from history and examination of previous medical records) Look for:  recurrent episodes of symptoms  recorded observation of wheeze  symptom variability  personal history of atopy  absence of symptoms of alternative diagnosis  historical record of variable PEF or FEV 1
  • 7. APPROACH TO MANAGEMENT Start treatment at the level most appropriate to initial severity. Achieve early control. Maintain control by: increasing treatment as necessary decreasing treatment when control is good.
  • 8.
  • 9. NEW BTS GUIDELINES Stepwise approach replaced by regular preventer and add on approach. This highlights short acting beta2 agonists are key ‘rescue therapy’ from symptoms or asthma attacks but should rarely be used on their own
  • 10. BTS GUIDELINES High probability of asthma: start initiation of treatment (typically 6 weeks of inhaled corticosteroids) Reasses with a validated symptom questionnaire and/or lung function tests (FEV1 or home serial peak flows Good symptomatic response to treatment - confirm diagnosis of asthma Record how the diagnosis was made Poor response or equivocal, check inhaler technique and adherence, arrange further tests and consider alternative diagnoses.
  • 11. INTERMEDIATE PROBABILITY OF ASTHMA Spirometry, with bronchodilator reversibility is preferred test Initiate treatment and assess the response by repeating lung function tests and objective measures of asthma control. In adults and children with an intermediate probability of asthma and normal spirometry results; Challenge tests FeNO to identify eosinophilic inflammation.
  • 12. E O S I N O P H I L S Elevated sputum eosinophil predict asthma exacerbations and responsiveness to ICS. Patients with blood eosinophil counts greater than 400 cells per μL experience have more severe exacerbations and have poorer asthma control. Price et al (2016) UK Cohort Study F E N O Raised eosinophil counts and exhaled nitric oxide (FeNO) are biomarkers of Th2 immune responses FeNo value in patient >12 years Low <20 ppb Intermediate 20-50 ppb High > 50 ppb In case of >40 ppb increase from previous stable levels interpret as high Schneider (2015) et al
  • 13. LOW PROBABILITY If there is a low probability of asthma and/or an alternative diagnosis is more likely, investigate for the alternative diagnosis and/or undertake or refer for further tests of asthma. BTS 2016
  • 14. SHORT ACTING ß2 AGONISTS  Side Effects: Fine tremor Tachycardia Hypokalaemia Restlessness Hypoxaemia  Cautions: Hyperthyroidism Cardiovascular disease Arrhythmias Susceptibility to QT-interval prolongation Hypertension Alleviate breathlessness by their direct affect on the airway by relaxing smooth muscle But they also: ↓ pulmonary hyperinflation ↑ mucociliary clearance Improve respiratory muscle function
  • 16. CHOICE Choice of drug (s) should take into account person’s - Preference to device - Symptomatic response - Ability to use the inhaler device effectively - Drugs potential to reduce exacerbations - Minimise side effects - Cost
  • 17. INHALER TECHNIQUE  Optimal inhaled particle deposition  requires a forceful inhalation for DPIs and a gentle inhalation for pMDI inhalers Bud60 Bud35 0 10 20 30 40 50 % Lung Deposition Insp Flow l/min Lung deposition of budesonide inhaled via Turbuhaler®: a comparison with terbutaline sulphate in normal subjects. Borgstrom et al. 1994 Acknowledgement Paul Pfeffer
  • 19. Supress inflammatory/immunological responses & mitigate against airway hyper- responsiveness It takes 1-4 weeks before the benefit of Introducing/up-titrating ICS is apparent A high level of drug deposits within the mouth and throat Oral candidiasis occurs as a consequence of this. Rinsing the mouth after may reduce the risk of oral opportunistic infection Battaglia et al., 2014
  • 20. BTS emphasise preventer medication to minimise future asthma attacks Add on therapy recommend combination inhaler (ICS/LABA) If a patient has poor control of their asthma, it is essential to check whether they are using their current drug treatment correctly and regularly, before stepping up treatment
  • 21. LEUKOTRIENE RECEPTOR AGONISTS Leukotrienes are inflammatory mediators produced by leukocytes which contribute to bronchospasm and airway hyper-responsiveness BTS recommend as add on therapy after Combination inhaler Example drugs include: Montelukast, Zafirlukast
  • 22. ICS & LABA COMBINATIONS
  • 23. MAINTENANCE AND RELIEVER THERAPIES (MART) Maintenance and Reliever Therapies are designed for adults (aged 18 or over). Evidence suggests MART reduces exacerbations, hospitalisation and SABA use Symbicort SMART Regime Fostair MART Regime DuoResp Spiromax MART Regime.
  • 24. pMDI DPI OD MART Step 1 Step 2/3 Step 3/4 ‘Inhaler Tree’ – Acknowledgement to Dr. Paul Pfeffer
  • 25. MULTIPLE INHALERS CONFUSE ASTHMA PATIENTS Study of 208 patients with a single inhaler type and 113 with multiple inhaler types. 29% error rate in patients with a single inhaler type 39% of patients with multiple inhaler types made significant errors. 32% error rate in patients with multiple DPI types. 46% error rate in patients with a pMDI and a DPI van der Palen et al. ERJ 1999
  • 26. Theophylline family of drugs e.g. Aminophylline, Theophylline, Phyllocontin Continus (SR) Inhibits the phosphodiesterase enzyme causing relaxation of the bronchial smooth muscle and bronchodilation Narrow therapeutic window – readily toxic (requires monitoring). Slow release drugs may be prescribed to treat poorly controlled asthma (step 4) Can be administered intravenously to terminate acute bronchospasms refractory to nebulised bronchodilators METHYLAXANTHINES
  • 27. MUSCARINIC ANTAGONIST Onset of action is slower than ß2 agonists  Approx 30mins Bronchodilator effects longer Side effects:  Dry mouth  Blurred vision  Paradoxical bronchospasm  Glaucoma – care with nebulisers T I O T R O P I U M R E S P I M A T ( S P I R I V A ® )Once daily LAMA Indication: maintenance bronchodilator in adult patients with asthma Dose: 2.5mcg TT puffs BD
  • 28. Omalizumab Indicated as an add on therapy to improve asthma control in adult and adolescent patients (12 years and above) with severe persistent allergic asthma which is not controlled on optimised BTS step 5 therapy NICE Technology appraisal (TA278) April 2013 Mepilizumab A targeted anti IL-5 therapy for adult patients with severe refractory eosinophilic asthma Humanised monoclonal antibody which inhibits the bioactivity of the cytokine interleukin (IL-5)
  • 29. FEVIPIPRANT Between 2012 and 2013, study carried out by University of Leicester/University of Oxford in the UK, and Novartis in Switzerland. RCT 61 participants received either fevipiprant tablets 225mg bd or a placebo for 12 weeks. Fevipiprant gave greater reduction in eosinophil count compared with placebo. Mean percentage of eosinophils in sputum decreased from 5.4% to 1.1%. It decreased in the placebo group from 4.6% to 3.9%. Gonem et al 2016. Lancet Volume 4. No 9, p699–707, September 2016
  • 30. MONITORING AND FOLLOW UP Flo-tone device In-check dial
  • 31. PERSONAL ASTHMA ACTION PLAN (PAAP)
  • 32. PAAP & ASTHMA REVIEW Triggers should be documented in patient notes and on asthma action plan Each review should review asthma control (asthma control test etc.) Ring et al., 2011 Gibson & Powell, 2004 Newell et al. 2015 Inhaler techniques should be routinely undertaken Non-adherence should be identified and monitored Urgent review for all with more than 12 short-acting beta agonist inhalers in previous 12 months
  • 33. WEIGHT LOSS Weight loss initiatives – including dietary and exercise programmes – can be offered for overweight or obese adults and children with asthma and may improve their asthma control
  • 34. PREGNANCY Women with asthma who are pregnant should be informed of the importance of continuing their asthma medication during pregnancy for the health of both mother and baby
  • 35. LONG ACTING ß2 AGONISTS The Asthma UK report published in June 2015 ‘Patient safety failures in asthma: the scale of unsafe prescribing in the UK’ identified 22,840 people prescribed a LABA or LAMA without ICS 106,742 people prescribed more than 12 short-acting bronchodilators a year Representing 0.4% and 2% respectively of the total 5.4 million people receiving treatment for asthma. It is dangerous to use a long-acting reliever inhaler without a steroid preventer inhaler
  • 37. SUMMARY Use inhaler device that patient is able to use Try to avoid generic prescribing Consider if diagnosis is correct if treatment is not reducing side effects or onwards referral Everyone with an asthma diagnosis should have a PAAP