module 5: treatment of severe asthma an educational program of: updated: june 2011
TRANSCRIPT
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Module 5:Treatment of Severe
AsthmaAuthors:Jean Bousquet, FranceRonald Dahl, Denmark
Michael A. Kaliner, USAConnie Katelaris, Australia
Contributer:Richard Lockey, USA
Severe asthma
•A shift in focus from severity to control
•How to control severe asthma
•Diagnosis and management of acute severe asthma
Lecture Objectives Section 1 – Asthma
ControlAt the end of this section participants
will be able to:• Diagnose severe asthma• Assess whether asthma is controlled • Outline appropriate treatment
strategies for optimal control of severe asthma
Definition of severe asthma
• Patients who need high dose inhaled CCS and long-acting ß2 agonists and:– are still uncontrolled – experience frequent acute exacerbations – and/or often require emergency treatment
and/or hospitalization
Diagnosis and classification of
asthmaAsthma severity is classified by:
• the presence of clinical features before treatment is started
• and/or by the amount of daily medication required for optimal treatment
GINA 2002
Intermittent
Classification of asthma: GINA 1998
Step 4>1000 BDP + LABA + other
Step 3200–1000 BDP
+ LABA
Step 2 <500 BDP
Step 1No controller
Current treatment step
Severe persistent
Severe persisten
t
Severe persisten
t
Severe persisten
t
Step 4
Symptoms daily
Frequent nocturnal symptoms
FEV1 <60% predicted
Severe persistent
Severe persisten
t
Severe persisten
t
Moderate persisten
t
Step 3
Symptoms daily
Nocturnal symptoms ≥1 x week
FEV1 60–80% predicted
Severe persistent
Severe persisten
t
Moderate persisten
t
Step 2
Symptoms >1 x week
Nocturnal symptoms <1 x week
Lung function normal between episodes
Severe persistent
Moderate persisten
t
Mild persisten
t
Step 1
Symptoms <1 x week
Nocturnal symptoms ≤2x month
Lung function normal between episodes
Clinical features
Mild persisten
t
Asthma management: from severity to control
There has been a shift in the paradigm for
asthma treatment; previousrecommendations for stepwise
implementation of pharmacotherapy were
based on disease severity, the focus is now on asthma control
GINA: goals of treatment 2006
GINA 2002
"The aim of asthma management should becontrol of the disease"
What is asthma control?
• To the patient– no symptoms which interfere with normal
lifestyle no exacerbations, normal quality-of-life
– particularly, no cough
• To carers (parents)– able to get to school, no night cough
• To the GP– no unscheduled visits, few exacerbations, no
admissions (sometimes maintenance of PEF)
• To the respiratory physician
– no night symptoms
– maintenance of lung function (FEV1)
– few exacerbations, no admissions
• To regulatory authorities
– improvement in a.m. PEF, FEV1
– improvement in symptom scores and quality of life
– enhanced cost effectiveness analyses
What is asthma control?
• Currently, single clinical endpoints, such as lung function, are often used to guide treatment
• Single endpoints may overestimate true asthma control1
• Other disease areas such as diabetes use a composite measure (HbA1c, blood pressure and cholesterol targets)2-4
A composite measure of control may help to improve
outcomes
1. Clark et al. Eur Respir J 2002 2. European Diabetes Policy Group 1999. Diabet Med 1999 3. Diabetes UK.Recommendations for the management of diabetes in primary care. 2nd ed. October 2000 4. Department of Health. NSF for Diabetes: Standards 5. British Thoracic Society/Scottish Intercollegiate Guidelines Network. British Guideline on the Management of Asthma. February 2003. 6. National Heart, Lung, and Blood Institute, World Health Organization. 1998
How can we assess control in practice?
We need simple tools that both healthcare providers and patients can use
– Asthma Control Questionnaire (ACQ)7-item questionnaire. Based upon day/night-time symptoms, daily activities, rescue bronchodilator
Juniper et al ERJ 1999; 14: 902-907
- Royal College of Physicians (RCP)3 questions based upon day/night-time symptoms and daily activities.
- Asthma Control Test (ACT)Validated instrument. 5 questions based upon day/night-time symptoms, rescue bronchodilator use and daily activities.
How can we assess control in practice ?
Br Med J 1990;301:651-653Nathan et al., J Allergy Clin Immun, 2004: 113(1): 59-65
Differences between scores
RCPrules
2ACQ ACT 30 sec
Night time symptoms
yes yes yes yes yes
Day time symptoms yes yes yes yes
Exercise, activities yes yes yes yes
Rescue medications (yes) yes yes yes yes
FEV1 or PEFR ACQ7
Duration of survey 1 wk or 1 mo
1 wk to
1 yr
1 wk 1 mo 1 wk to 3 mo
Levels of asthma control
CharacteristicControlled
(All of the following)
Partly controlled(Any present in any
week)Uncontrolled
Daytime symptomsNone (2 or less/ week)
More than twice/week
3 or more features of partly controlled asthma present in any week
Limitations of activities None Any
Nocturnal symptoms/ awakening
None Any
Need for rescue/ “reliever” treatment
None (2 or less/ week)
More than twice/week
Lung function (PEF or FEV1)
Normal< 80% predicted or
personal best (if known) on any day
Exacerbation None One or more/year 1 in any week
Asthma Management and Prevention Program
Goals of long-term management
• Achieve and maintain control of symptoms• Maintain normal activity levels, including
exercise• Maintain pulmonary function as close to
normal levels as possible• Prevent asthma exacerbations• Avoid adverse effects from asthma
medications• Prevent asthma mortality
Severe asthma
• A shift in focus from severity to control
• How to control severe asthma• Diagnosis and management of
acute severe asthma
Asthma Management and Prevention Program
• Asthma can be effectively controlled in most patients by intervening to suppress and reverse inflammation as well as treating bronchoconstriction and related symptoms
• Early intervention to stop exposure to the risk factors that sensitized the airway may help improve the control of asthma and reduce medication needs
• Depending on level of asthma control, the patient is assigned to one of five treatment steps
• Treatment is adjusted in a continuous cycle driven by changes in asthma control status. The cycle involves:
- Assessing Asthma Control
- Treating to Achieve Control
- Monitoring to Maintain Control
Asthma Management and Prevention
Program Component 3: Assess, treat and monitor asthma
Assess asthma control
Maintain treatment
orStep down
Step up untilcontrolled
Management of asthma in adults and adolescents (GINA 2006 adapted)
Controlled Partially controlled Uncontrolled
No controllertreatment
Step 2
Controllertreatment
Step up
Exacerbation
Treat asexacerbation
Step 4 – Reliever medication plus two or more
controllers
• Selection of treatment at Step 4 depends on prior selections at Steps 2 and 3
• Where possible, patients not controlled on Step 3 treatments should be referred to a health professional with expertise in the management of asthma
Treating to achieve asthma control
Step 4 – Reliever medication plus two or more controllers
• Medium- or high-dose inhaled glucocorticosteroid combined with a long-acting inhaled β2-agonist (Evidence A)
• Medium- or high-dose inhaled glucocorticosteroid combined with leukotriene modifiers (Evidence A)
• Low-dose sustained-release theophylline added to medium- or high-dose inhaled glucocorticosteroid combined with a long-acting inhaled β2-agonist (Evidence B)
Treating to achieve asthma control
Treating to achieve asthma control
Step 5 – Reliever medication plus additional
controller options
• Addition of oral glucocorticosteroids to other controller medications may be effective (Evidence D) but is associated with severe side effects (Evidence A)
• Addition of anti-IgE treatment to other controller medications improves control of allergic asthma when control has not been achieved on other medications (Evidence A)
Treating to maintain asthma control
• When control as been achieved, ongoing monitoring is essential to:
- maintain control
- establish lowest step/dose of treatment
• Asthma control should be monitored by the health care professional and by the patient
Treating to maintain asthma control
Stepping down treatment when asthma is controlled• When controlled on medium- to
high-dose inhaled glucocorticosteroids: 50% dose reduction at 3 month intervals (Evidence B)
• When controlled on low-dose inhaled glucocorticosteroids: switch to once-daily dosing (Evidence A)
Treating to maintain asthma control
Stepping down treatment when asthma is controlled• When controlled on combination inhaled
glucocorticosteroids and long-acting inhaled β2-agonist, reduce dose of inhaled glucocorticosteroid by 50% while continuing the long-acting β2-agonist (Evidence B)
• If control is maintained, reduce to low-dose inhaled glucocorticosteroids and stop long-acting β2-agonist (Evidence D)
Treating to maintain asthma control
Stepping up treatment in response to loss of control• Rapid-onset, short-acting or long-
acting inhaled β2-agonist bronchodilators provide temporary relief.
• Need for repeated dosing over more than one/two days signals need for possible increase in controller therapy
Treating to maintain asthma control
Stepping up treatment in response to loss of control• Use of a combination long-acting inhaled β2-
agonist (e.g., salmeterol, formoterol) and an inhaled glucocorticosteroid (e.g., fluticasone, budesonide) in a single inhaler both as a controller and reliever is effective in maintaining a high level of asthma control and reduces exacerbations (Evidence A)
• Doubling the dose of inhaled glucocorticosteroids is not effective, and is not recommended (Evidence A)
Treating to maintain asthma control
• When control as been achieved, ongoing monitoring is essential to:
- maintain control
- establish lowest step/dose of treatment
• Asthma control should be monitored by the health care professional and by the patient
Guided self-management plans GINA 2006 (adapted)
• Guided self management action plans enable patients with asthma to gain the knowledge, confidence and skills to assume a major role in the management of their asthma, reducing asthma morbidity in adults (Evidence A) and children (Evidence A).
Monitoring asthma: peak flow meters
Peak flow meters are useful to monitor asthma and prevent exacerbations:
• Inexpensive• Easy to use• Accurate• Provide “real life” measurements at worst and best times of the day• Provide objective measurement of pulmonary function• Detect early changes of asthma worsening
Patient “self management” based on peak flow
measurementIf personal best peak flow
measurements:
– Fall 10+%, double dose of inhaled CCS– Fall 20+%, use short-acting bronchodilator Q4 -6
hour, plus 2-4 x inhaled CCS– Call office, try to determine if infection is present– Fall 40 - 50%, add oral CCS– Fall greater than 50%, urgent visit to either
• Outpatient office • Emergency room
Kaliner In: Current Review of Asthma. Current Medicine, 2003
Use of inhaled corticosteroids
Rabe et al. Eur Respir J 2000;www.asthmainamerica.com;Lai et al. J Allergy Clin Immunol 2003;Data on file
Copyright permission for reproduction pending
Preventing exacerbations -underlying causes and patient
education Evaluate patient for :
– Allergy– Infection– Compliance– Inappropriate
concomitant medications– Social factors– Tobacco, drugs, irritants,
fumes– Psychiatric disordersInitiate or review patient education and self-management plan
Role of allergy in managing asthma
• 90% of asthmatics <16 years old are allergic• 70% of asthmatics 16-30 are allergic• 50% of adult asthmatics are allergic• Any asthmatic who wheezes 2 times/week
needs an allergy assessment• Allergy avoidance and allergy vaccination are
effective treatments for asthma (Evidence A)• Allergy treatment is both cost-effective and is
the only treatment capable of reducing asthma long-term
The main goal of the 10 year Finnish Asthma
Programme:
• To lessen the burden of asthma on individuals and society
Finnish Asthma Programme: Measures to achieve the
goals• Early diagnosis and active treatment• Guided self-management as the primary form of treatment• Reduction in respiratory irritants such as smoking and
environmental tobacco smoke• Implementation of patient education and rehabilitation
combined with normal treatment, planned individually and timed appropriately
• Increase in knowledge about asthma in key groups; and promotion of scientific research
• Appointment of one doctor, one nurse and one pharmacist responsible for asthma care in each clinic/region
Healthcare benefits from asthma intervention
Haahtela et al, Thorax 1998
Ast
hm
a I
ndic
es
(base
100 i
n 1
981) Reimbursement asthma
Hospitalization daysDeath rate
Year
350
300
250
200
150
100
50
0
1981 1983 1985 1987 1989 1991 1993 1995
Healthcare benefits from asthma intervention
Finnish Asthma Programme (1994-2004)
Haahtela et al, Thorax 2006
-80
-60
-40
-20
0
20
40
60%
ch
an
ge 1
993-2
00
3
asthmaprevalence
hospitaldays
disabilitypension
total costscost per ptper year
Summary• Asthma management in 2007 is focused on
control of the individual patient’s asthma symptoms, a paradigm shift from earlier recommendations of a step-wise increase in therapy based on asthma severity;
• Patient self-management plans play an important role in prevention of exacerbations;
• Successful asthma interventions lead to increased medication costs but decreased costs for hospitalization, and decreased death rates;
• Allergen exposure is an important contributory factor in exacerbations of IgE-mediated asthma.
Severe asthma
•A shift in focus from severity to control
•How to control severe asthma•Diagnosis and management of
acute severe asthma
Lecture objectives: Section 2
At the end of this section participants will be able to:
• Understand the risk factors for asthma exacerbations
• Understand the pathophysiology of acute severe asthma
• Identify the signs and symptoms of acute asthma
• Outline appropriate treatment strategies for optimal control of acute asthma exacerbations
Frequency of hospital and emergency room visits in
moderate-severe asthmatics; TENOR study
Rabe et al. Eur Respir J 2000;www.asthmainamerica.com;Lai et al. J Allergy Clin Immunol 2003;Adachi et al. Arerugi 2002;Data on file
Copyright permission for reproduction pending
Slight Moderate
Acute severe asthma monitoring
Severe
the cross-road of death
Slight Moderate
SevereNormo- ventilation
Hyper-ventilation
HypoventilationExhaustion
RHONCHI
Bronchial Asthma
Spirometric abnormaliti
es
Central airway
narrowing
Bronchoconstriction
Gas exchange abnormalities
Distal airway narrowing
Airway Inflammation
Treatments must be directed towards these two components:
Smooth muscle spasm Inflammation, edema, plugs
Features of a severe asthma exacerbation
One or more present:• Use of accessory muscles of respiration• Pulsus paradoxicus >25 mm Hg• Pulse > 110 BPM• Inability to speak sentences• Respiratory rate >25 - 30 breaths/min• PEFR or FEV1 < 50% predicted• SaO2 <91- 92%
McFadden Am J Respir Crit Care Med 2003
Risk factors for fatal or near-fatal asthma attacks
• Previous episode of near-fatal asthma• Multiple prior ER visits or hospitalizations• Poor compliance with medical treatments• Adolescents or inner city asthmatics• (USA) African-Americans>Hispanics>Caucasians• Allergy to Alternaria• Recent use of oral corticosteroid (OCS)• Inadequate therapy:
– Excessive use of β-agonists– No inhaled corticosteroid (ICS)– Concomitant β-blockers
Ramirez and Lockey In: Asthma, American College of Physicians, 2002
Physical findings in severe asthma exacerbations
• Tachypnea• Tachycardia• Wheeze• Hyperinflation• Accessory muscle use• Pulsus paradoxicus• Diaphoresis (profuse sweating)• Cyanosis• Sweating• Obtundation (altered mental state)
Brenner, Tyndall and Crain In: Emergency Asthma. Marcel Dekker 1999
Causes of asthma exacerbations
• Lower or upper respiratory infections
• Cessation or reduction of medication
• Concomitant medication, e.g. β-blocker
• Allergen or pollutant exposure
Differential diagnosis
• COPD• Bronchitis• Bronchiectasis• Endobronchial
diseases• Foreign bodies• Extra- or intra-
thoracic tracheal obstruction
• Carcinoid syndrome
• Cardiogenic pulmonary edema
• Non-cardiogenic pulmonary edema
• Pneumonia• Pulmonary emboli• Chemical
pneumonitis• Hyperventilation
syndrome
Brenner, Tyndall, Crain In: Emergency Asthma. Marcel Dekker, 1999
Acute severe asthma – associations and differential
diagnoses• Hyperventilation syndrome• Vocal cord dysfunction• Vaso-vagal reaction• Anaphylactic reaction (urticaria, BP, pulse
rate, etc)• Aspiration - foreign body – pneumonia• Pneumothorax• Cardiac failure• Lung emboli
Stages of asthma exacerbations
Stage 1:Symptoms• Somewhat short of breath• Can lie down and sleep through the night• Cannot perform full physical activities without
shortness of breathSigns• Some wheezes on examination• Respiratory rate, 15 (normal <12)• Pulse 100• Peak flows and spirometry reduced by 10%
Stages of asthma exacerbations
Stage 2:Symptoms• Less able to do physical activity due to shortness of
breath• Dyspnea on walking stairs• May wake up at night short of breath• Uncomfortable on lying down• Some use of accessory muscles of respiration
Signs• Wheezing• Respiratory rate 18• Pulse 111• Peak flows and spirometry reduced by 20+%
Stages of asthma exacerbations
Stage 3:Symptoms• Unable to perform physical activity without
shortness of breath• Cannot lie down without dyspnea• Speaks in short sentences• Using accessory muscles
Signs• Wheezing• Respiratory rate 19 - 20• Pulse 120• Peak flows and spirometry reduced by 30+%
Stages of asthma exacerbations
Stage 4:Symptoms• Sitting bent forward• Unable to ambulate without shortness of breath• Single word sentences• Mentally-oriented and alert• Use of accessory musclesSigns• Wheezing less pronounced than anticipated• Respiratory rate 20 - 25• Pulse 125+• Peak flows and spirometry reduced by 40+%• SaO2 91- 92%
Stages of asthma exacerbations
Stage 5:Symptoms• Reduced consciousness• Dyspnea• Silent chest – no
wheezingSigns• Fast, superficial
respiration• Respiratory rate >25• Unable to perform peak
flows or spirometry• Pulse 130 - 150+ • SAO2 <90
Severity of asthma as graded by % predicted FEV1
FEV% predicted Severity• 70 - 100 Mild• 60 - 69 Moderate• 50 - 59 Moderately
severe• 35 - 49 Severe• < 35 Very severe:
(life-threatening)
Acute severe asthma - clinical assessment
• Respiratory frequency: (count)– Speech: sentences, single words
• Auxiliary respiratory muscle use• Posture: sitting, can patient lie down?• Airway patency: rhonchi, silent chest
(PEF)• Respiration: cyanosis (SaO2, blood gases) • General appearance, effort of
breathing: activity level (pulse rate)
ACUTE ASTHMA – MONITORING CHART Name: History: Birth date: Date: Time first seen:
Time
Pulse rate
Respiratory
rate
Use of accessory muscles
PEF
Pulse oximetry (SaO2)
Cyanosis
Exhaustion
Oxygen
flow
Treatment
_________
Neck Abdomen Arms
______ l/m
Short Acting Beta Agonist Dose: ____________ Delivery: Nebuliser/Spacer Oral steroid: ________ Inhaled steroid: ______
_________
Neck Abdomen Arms
______ l/m
Short Acting Beta Agonist Dose: ____________ Delivery: Nebuliser/Spacer Oral steroid: ________ Inhaled steroid: ______
_________
Neck Abdomen Arms
______ l/m
Short Acting Beta Agonist Dose: ____________ Delivery: Nebuliser/Spacer Oral steroid: ________ Inhaled steroid: ______
Acute severe asthma
Admission and close monitoring in hospital unit:
• Clinical stage 4• PEF or FEV1 < 30% of personal best (if unknown < 30% predicted)• PaCO2 > 6 kPa• PaO2 < 8 kPa• Poor response to initial treatment
Acute severe asthma treatment
Oxygen by nasal cannulae or mask
Inhaled broncodilator should be administered atregular Intervals (Evidence A): Nebulised ß2-agonist combined with anticholinergic each20 mins in the first hour, then hourly as necessary
Systemic steroid should be utilised in all but the Mildest Exacerbations (Evidence A):Oral (50-75mg prednisolone) or i.v. corticosteroid (80 mgMethylprednisolone); repeat after 12 hours; over the following
days 40 mg prednisolone or equivalent is usually maintained
Start inhaled high dose steroid as soon as possible
Acute severe asthma treatment
Dangerous, or at least ineffectiveDangerous: SedationIneffective: Mucolytics
PhysiotherapyAntihistamines
Acute severe asthma treatment
Consider:Infusion of Beta-2-agonist Infusion of theophylline Antibiotics – not all acute asthma exacerbations require antibioticsFluids
Acute severe asthma – treatment options
Standard treatment:Oxygen
Inhaled beta-2-agonist +/- anticholinergicSystemic corticosteroidAdditional options:
Systemic beta-2-agonist and/or theophylline, antibiotics, fluids
Nonstandard treatment:Antileukotrienes; Magnesium sulphate; Heliox; Bi-pap
Extreme intervention:Intubation and controlled hypoventilation/other
strategyAnesthesia-sedation; Bronchial lavage
Treatment of asthma exacerbations
oral corticosteroids• Oral corticosteroids are the most powerful
medications available to reduce airway inflammation
• Use until attack has completely abated:– PEFR and FEV1 at baseline levels– Symptoms gone
• Taper to QOD and determine if patient can remain well if corticosteroids are withdrawn completely
Acute severe asthma
• Treat the condition symptomatically• Determine what caused the
exacerbation:– inhalant allergen– food allergen– drug reaction (ASA, vaccination, etc)– infection– worsening of a chronic condition: - poor therapy compliance
- treatment needs adjustment
Prevention of relapse and recurrence of asthma
exacerbation - definitionRelapse: Reappearance of asthma symptoms that require unscheduled care within 3 weeks of an asthma exacerbation
Recurrence: Reappearance of asthma symptoms that require unscheduled care more than 3 weeks after the asthma exacerbation
Prevention of relapse and recurrence of asthma
exacerbationPatients treated for an asthmaexacerbation are at risk for subsequent severe attacks: (unscheduled doctor visits, Emergency Department visits,hospitalization, asthma death)
Proper asthma care can reduce this risk:a) Pharmacological
intervention with ICS b) Patient education –
knowledge and skillsc) Self management plans
and follow up
Prospective multicenter study of relapse after ED care of acute
severe asthma Relapse rate: 17%
Associations ORMultiple previous ED visits for asthma
1.3Use of home nebulizer 2.2Long duration of symptoms 2.5Report of multiple triggers (per trigger)
1.1
Emerman C et.al. Chest 1999; 115: 919-27
Comparison of short course of Inhaled CS and Oral CS for acute asthma
exacerbation in primary care
413 patient in 47 general practices.
Treatments: a) oral prednisolone 40mg daily for 16 days b) inhaled FP 1000mcg x 2 daily for16 days
Outcome was failure:Defined by symptoms and/or PEF
Levy ML et el. Thorax; 1996; 51: 1087-92
Comparison of short courses of OCS vs ICS in the treatment of
asthma exacerbation in primary care
Levy ML, et al. Thorax 1996; 51:1087-1092
Copyright permission for reproduction pending
Viral respiratory infection and asthma exacerbations
Studies using PCR techniques have shown that viral infection is a
common cause of asthma exacerbations.
Age n Setting %viral Reference _______ 19-46y 138 Outpatient 55 Nicholson BMJ 1993
9-11y 108 Outpatient 85 Johnston BMJ 1995
6m-12y 75 Hospitalized 82 Freymoth JCVirol 1999
2m-16y 70 ED 83 Rakes AJRCCM 1999
Antibiotics in asthma exacerbations
• Use antibiotics if any suspicion of bacterial
infection• If antibiotics are prescribed,
recommendation is for broad spectrum macrolide antibiotics that cover atypical bacteria (chlamydia, mycoplasma), eg, azithromycin, clarithromycin, erythromycin, roxithromycin, dirithromycin, amoxicillin + clavulan; moxifloxacin, cefuroxim
Delays in seeking help for acute asthma - the patient’s
perspective 95 patients explained their reasons for
delaying seeking professional care:• Uncertainty 74%• Disruption 86%• Minimization 90%• ”Self-reliance” 46%• Fear of steroids 31%
• To avoid ED 34%• Economic reasons 5%
Janson S. J Asthma 1998; 35: 427-35
Acute severe asthma
IS A RESPIRATORY ATTACK!
• Treat, Monitor and Follow-up
• Consider improved prophylaxis:
- allergen avoidance - allergen vaccination - pharmacological treatment update
- stop smoking - enhance compliance to recommendations by teaching and monitoring
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