Professional Documents
Culture Documents
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Treatment
Goals
Lifestyle/Non-Pharmacologic Options
Pharmacologic Options: Stepwise Charts
Patients aged 04 years
Patients aged 511 years
Patients aged 12 years and older
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Follow-up/Monitoring
Condition/Complication Monitoring
Comorbidity Screening
Comorbidity Prevention
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Evidence Summary
References
Clinician Lead and Guideline Development
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Appendices
1. Asthma Action Plan
2. Asthma Control Test For children aged 411 years
3. Asthma Control Test For people aged 12 years and older
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Guidelines are systematically developed statements to assist patients and providers in choosing appropriate health
care for specific clinical conditions. While guidelines are useful aids to assist providers in determining appropriate
practices for many patients with specific clinical problems or prevention issues, guidelines are not meant to replace
the clinical judgment of the individual provider or establish a standard of care. The recommendations contained in the
guidelines may not be appropriate for use in all circumstances. The inclusion of a recommendation in a guideline
does not imply coverage. A decision to adopt any particular recommendation must be made by the provider in light of
the circumstances presented by the individual patient.
Diagnosis
Establish a diagnosis
To establish a diagnosis of asthma:
Use history and physical to determine whether symptoms of recurrent episodes of airflow
obstruction or airway hyperresponsiveness are present. (Table 1)
Use spirometry in patients 5 years and older to determine whether airflow obstruction is at least
partially reversible. (Table 2)
Consider alternative diagnoses or comorbid conditions:
- Pulmonary diseases (e.g., COPD, pulmonary fibrosis, bronchiectasis, tracheobronchial stenosis
or malacia)
- Upper airway conditions (e.g., chronic rhinosinusitis, vocal cord dysfunction, obstructive sleep
apnea)
- Foreign body
- Obesity
- GERD
- Hyperventilation syndrome
Table 1. History and physical examination
Pertinent positives
History
Physical
examination
FEV1 /FVC
Less than 0.85
Less than 0.80
Less than 0.75
Less than 0.70
To determine reversibility, FEV1 is measured before and after the patient inhales a short-acting beta2
agonist (SABA). In patients of all ages, reversibility is indicated by an increase of at least 12% in FEV1 from
baseline; in adults, an increase in FEV1 of greater than 200 mL from baseline also constitutes reversibility.
Some patients who have signs and symptoms of asthma may not demonstrate reversibility until after a 2- to
3-week trial of oral corticosteroid therapy is administered to help improve their asthma control.
Note: Having normal lung function does not exclude the diagnosis of asthma, especially in children.
Intermittent
asthma
Moderate
Severe
Up to
2 days/week
More than
2 days/week
Daily
Nighttime
awakenings
12x/month
34x/month
Up to
Short-acting
beta2 agonist use 2 days/week
(for rescue, not
exercise
prophylaxis)
More than
2 days/week
Daily
Minor limitation
Some limitation
Extreme limitation
N/A
N/A
N/A
N/A
N/A
N/A
FEV1 /FVC
N/A
Risk
Exacerbations
Up to 1x/year
requiring systemic
corticosteroids
Therapy
recommendation
See 04 Year
Stepwise Chart,
pp. 1213.
Mild
Symptoms
Lung function:
FEV1 predicted N/A
Persistent asthma
Initiate therapy
at Step 1.
Initiate therapy
at Step 3.
Initiate therapy
at Step 3.
Consider short
Consider short
course of systemic course of systemic
corticosteroids.
corticosteroids.
Patients with 2 or more exacerbations may be considered the same as patients who have persistent asthma,
even in the absence of impairment consistent with persistent asthma.
Initiate daily long-term control therapy for children who had 4 or more episodes of wheezing in the past year
that lasted longer than 1 day and affected sleep and who have either:
One of the following: parental history of asthma, physician diagnosis of atopic dermatitis, or evidence of
sensitizations to inhaled allergens, or
Two of the following: sensitization to foods, blood eosinophilia of 4% or higher, or wheezing apart from
colds.
Table 3b. Patients aged 04 years currently taking medications: assessing asthma control
Assess each component over the last 24 weeks. The result is based on the score of the most
severe component.
Asthma is:
Impairment
Well controlled
Symptoms
Nighttime
awakenings
Up to 1x/month
Short-acting beta2
Up to 2 days/week
agonist use (for
rescue, not exercise
prophylaxis)
Interference with
normal activity
None
Some limitation
Extreme limitation
N/A
N/A
N/A
N/A
N/A
N/A
Questionnaire
N/A
N/A
N/A
Risk
Exacerbations
requiring systemic
corticosteroids
01x/year
23x/year
Therapy
recommendation
See 04 Year
Stepwise Chart,
pp. 1213.
Maintain therapy at
current step.
Step up 1 step. 1
Step up 12 steps. 1
Follow-up
Every 16 months
Lung function:
FEV1 predicted
FEV1 /FVC
2 weeks
Before stepping up therapy, review adherence to medication, inhaler technique, and environmental control.
Intermittent
asthma
Persistent asthma
Mild
Moderate
Severe
Symptoms
Up to
2 days/week
More than
2 days/week
Daily
Nighttime
awakenings
Up to 2x/month
34x/month
Often 7x/week
Short-acting beta2
Up to
agonist use (for
2 days/week
rescue, not exercise
prophylaxis)
More than
2 days/week
Daily
Interference with
normal activity
Minor limitation
Some limitation
Extreme limitation
6080%
Greater than
0.85
0.750.80
Up to 1x/year
At least 2x/year 2
At least 2x/year 2
At least 2x/year 2
Initiate therapy
at Step 1.
Initiate therapy
at Step 2.
Initiate therapy
at Step 3, mediumdose inhaled
corticosteroid
option.
Initiate therapy
at either Step 3,
medium-dose
inhaled
corticosteroid
option, or at Step 4.
Lung function:
FEV1 predicted
FEV1 /FVC 1
Risk
Exacerbations
requiring systemic
corticosteroids
Therapy
recommendation
See 511 Year
Stepwise Chart, pp.
1415.
None
Consider short
course of systemic Consider short
course of systemic
corticosteroids.
corticosteroids.
1
2
Table 4b. Patients aged 511 years currently taking medications: assessing asthma control
Assess each component over the last 24 weeks. The result is based on the score of the most severe
component.
Asthma is:
Impairment
Well controlled
Symptoms
Up to 2 days/week
Nighttime awakenings
Up to 1x/month
At least 2x/month
At least 2x/week
Up to 2 days/week
None
Some limitation
Extreme limitation
6080%
0.750.80
Questionnaire Childhood
ACT score
20 or higher
1319
12 or lower
Risk
Exacerbations requiring
systemic corticosteroids
01x/year
23x/year
Therapy recommendation
See 511 Year Stepwise
Chart, pp. 1415.
Maintain therapy at
current step.
Step up at least 1
step. 1
Step up 12 steps. 1
Lung function:
FEV1 predicted
FEV1 /FVC
Every 16 months
26 weeks
2 weeks
Before stepping up therapy, review adherence to medication, inhaler technique, and environmental control.
Intermittent
asthma
Persistent asthma
Mild
Moderate
Severe
Symptoms
Up to
2 days/week
More than
2 days/week
Daily
Nighttime
awakenings
Up to 2x/month
34x/month
Often 7x/week
Short-acting beta2
Up to
agonist use (for
2 days/week
rescue, not exercise
prophylaxis)
More than
2 days/week but
not more than
1x/day
Daily
Interference with
normal activity
Minor limitation
Some limitation
Extreme limitation
6080%
None
Lung function:
Normal between Greater than 80%
FEV1 predicted or exacerbations;
personal best
greater than
80%
FEV1 /FVC 1
Risk
Exacerbations
requiring systemic
corticosteroids
Normal
Normal
Reduced 0.05
Up to 1x/year
At least 2x/year 2
At least 2x/year 2
At least 2x/year 2
Initiate therapy
at Step 2.
Initiate therapy
at Step 3.
Initiate therapy
at Step 4 or 5.
Initiate therapy
Therapy
at Step 1.
recommendation
See 12+ Year Stepwise
Chart, pp. 1617.
Consider short
Consider short
course of systemic course of systemic
corticosteroids.
corticosteroids.
Table 5b. Patients aged 12 years and older currently taking medications: assessing asthma
control
Assess each component over the last 24 weeks. The result is based on the score of the most severe
component.
Asthma is:
Impairment
Well controlled
Symptoms
Up to 2 days/week
Nighttime awakenings
Up to 2x/month
13x/week
At least 4x/week
Up to 2 days/week
None
Some limitation
Extreme limitation
6080%
20 or higher
1619
15 or lower
Risk
Exacerbations requiring
systemic corticosteroids
Up to 1x/year
At least 2x/year
At least 2x/year 2
Step up at least 1
step. 1
Step up 12 steps. 1
Consider short
course of systemic
corticosteroids.
26 weeks
2 weeks
Maintain current
Therapy recommendation
See 12+ Year Stepwise Chart, step.
pp. 1617.
If well controlled
for at least
3 months,
consider step
down.
Follow-up
1
Every 16 months
Before stepping up therapy, review adherence to medication, inhaler technique, and environmental control.
Treatment
Goals
Table 6. Goals of asthma treatment
Reduce
impairment.
Reduce risk.
10
Patient monitors symptoms and/or uses a peak flow meter to assess control and signs
of worsening.
Consider use of a peak flow meter for patients who have moderate or severe
persistent asthma or a history of severe exacerbations, or who poorly perceive airflow
obstruction and worsening asthma. Patient instructions for using peak flow meters are
available on ghc.org, at
https://provider.ghc.org/open/caringForOurMembers/patientHealthEducation/conditionsDiseases
/peakFlowMeter.pdf
Follow an
Asthma Action
Plan.
With provider, patient develops and follows a written Asthma Action Plan that includes
instructions for:
Daily management
Environmental control measures
Self-monitoring to assess control and signs of worsening either through
symptoms or peak flow
Managing worsening asthma
Take medication Patient instructions for using the following inhalers and devices are available on
correctly.
ghc.org, at
https://provider.ghc.org/open/caringForOurMembers/patientHealthEducation/index.jhtml
Tobacco smoke
Strong odors or sprays
Dust mites
Cockroaches
Animal dander
Pollen and outdoor mold
Indoor mold
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Consider
immunotherapy.
Encourage
physical activity.
Encourage
tobacco
cessation.
Encourage
weight
management.
The risk of serious health conditions increases with body mass index (BMI) of 25
or higher. While most overweight or obese adults can lose weight by eating a
healthy diet or increasing physical activity, doing both is most effective.
See the Weight Management Guideline for recommendations and further
information.
Pharmacologic Options
Stepwise charts for long-term management of asthma begin on the following page.
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Pharmacologic Options: Stepwise Approach to Long-term Asthma Management in Patients Aged 04 Years
For notes to this chart, including abbreviations used, see following page.
INTERMITTENT
Symptoms
Step 1
PERSISTENT
Symptoms
Step 2
Step 3
Step 4
Step 5
Step 6
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours prn
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours prn
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours prn
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours prn
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours prn
High-dose ICS
1st line
Fluticasone (Flovent)
HFA/MDI
Greater than 176 mcg twice
daily, delivered with face
mask and spacer
High-dose ICS
1st line
Fluticasone (Flovent)
HFA/MDI
Greater than 176 mcg twice
daily, delivered with face
mask and spacer
and
either LTRA
(Age 24 years)
Montelukast (Singulair) tablet
(PA)
4 mg daily at bedtime
or LABA
(Age 4 years)
Salmeterol (Serevent) DPI
(PA)
50 mcg every 12 hours
and
either LTRA
(Age 24 years)
Montelukast (Singulair) tablet
(PA)
4 mg daily at bedtime
or LABA
(Age 4 years)
Salmeterol (Serevent) DPI
(PA)
50 mcg every 12 hours
1,2
Low-dose ICS
1st line
Fluticasone (Flovent)
HFA/MDI 88 mcg twice
daily, delivered with face
mask and spacer
Medium-dose ICS
1st line
Fluticasone (Flovent)
HFA/MDI 88176 mcg twice
daily, delivered with face
mask and spacer
Medium-dose ICS
1st line
Fluticasone (Flovent) HFA/MDI
88176 mcg twice daily,
delivered with face mask and
spacer
Long-term control
medication
2,3
ALTERNATIVE
LTRA
Age 1223 months:
Montelukast (Singulair) oral
granules (NF)
4 mg daily at bedtime
Age 24 years:
Montelukast (Singulair)
tablet (PA)
4 mg daily at bedtime
and
either LTRA
(Age 24 years)
Montelukast (Singulair) tablet
(PA)
4 mg daily at bedtime
or LABA
(Age 4 years)
Salmeterol (Serevent) DPI
(PA)
50 mcg every 12 hours
and
Oral systemic
corticosteroid
Prednisone burst:
12 mg/kg/day.
Maximum 60 mg/day for
310 days
13
Other alternatives
Theophylline:
- Starting dose: 10 mg/kg/day
- Usual maximum for age under 12 months: [0.2 (age in weeks) + 5] = mg/kg/day
- Usual maximum for age 12 months or over: 16 mg/kg/day
14
Pharmacologic Options: Stepwise Approach to Long-term Asthma Management in Patients Aged 511 Years
For notes to this chart, including abbreviations used, see following page.
INTERMITTENT
Symptoms
Step 1
PERSISTENT
Symptoms
Step 2
Step 3
Step 4
Step 5
Refer to asthma
specialist
Step 6
Refer to asthma
specialist
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours
prn
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours prn
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours prn
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours
prn
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours
prn
Medium-dose ICS/LABA:
Fluticasone/salmeterol (Advair
Diskus) DPI 100 mcg/50 mcg
twice daily, 12 hours apart
(PA: criteria include not well
controlled on medium-dose ICS)
High-dose ICS/LABA:
Fluticasone/salmeterol
(Advair Diskus) DPI
250 mcg/50 mcg
500 mcg/50 mcg twice
daily, 12 hours apart
(PA: criteria include not
well controlled on
medium-dose ICS)
High-dose ICS/LABA:
Fluticasone/salmeterol
(Advair Diskus) DPI
250 mcg/50 mcg
500 mcg/50 mcg twice
daily, 12 hours apart
(PA: criteria include not
well controlled on
medium-dose ICS)
Medium-dose ICS
1st line
Fluticasone (Flovent) HFA/MDI
w/spacer
88176 mcg twice daily
2nd line
Beclomethasone (QVAR)
HFA/MDI w/spacer
4080 mcg twice daily
2nd line
Beclomethasone (QVAR) HFA/MDI
w/spacer
80160 mcg twice daily
1, 2
Low-dose ICS
1st line
Fluticasone (Flovent) HFA/MDI
w/spacer
4488 mcg twice daily
Medium-dose ICS
1st line
Fluticasone (Flovent) HFA/MDI
w/spacer
88176 mcg twice daily
2nd line
Beclomethasone (QVAR) HFA/MDI
w/spacer
4080 mcg twice daily
2nd line
Beclomethasone (QVAR) HFA/MDI
w/spacer
80160 mcg twice daily
and
either LABA
Salmeterol (Serevent) DPI (PA)
50 mcg every 12 hours
or LTRA
Montelukast (Singulair) tablet (PA)
and LTRA
Montelukast (Singulair) tablet
(PA)
15
Notes
1
Leukotriene receptor antagonist (montelukast):
Not covered for allergic rhinitis, sinusitis or atopic dermatitis
Prior Authorization criteria:
1. Patients aged 12 months or over who have asthma and are unable to use inhaled corticosteroids because of medical contraindications or inability to manipulate
the inhaler. In these patients, a clinical response to montelukast must be documented for continued coverage. Rationale: montelukast is less effective than
inhaled corticosteroids.
2. For children under 12 years of age with asthma who are able to use inhaled corticosteroids, but not controlled on medium-dose inhaled corticosteroid
monotherapy, montelukast can be added to inhaled corticosteroid treatment.
3. For treatment of exercise-induced bronchospasm for athletes and children who do not have indications for inhaled corticosteroids and fail albuterol because they
are active for a substantial part of the day or because the time of their activity is not predictable.
4. For individuals who have history of systemic (anaphylactic) reaction to allergy immunotherapy, and poor response to at least one antihistamine pre-treatment
(i.e., diphenhydramine, loratadine, fexofenadine, cetirizine), montelukast can be added to antihistamine pre-treatment.
2
Other alternatives
Theophylline:
- Starting dose: 10 mg/kg/day up to 300 mg/day
- Usual maximum dose: 16 mg/kg/day up to 600 mg/day
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Pharmacologic Options: Stepwise Approach to Long-term Asthma Management in Patients Aged 12 Years and Older
For notes to this chart, including note about pregnancy and abbreviations used, see following page.
INTERMITTENT
Symptoms
Step 1
PERSISTENT
Symptoms
Step 2
Step 3
Step 4
Step 5
Refer to asthma
specialist
Step 6
Refer to asthma
specialist
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours
prn
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours prn
Medium-dose ICS
1st line
Beclomethasone
(QVAR) HFA/MDI w/spacer
120240 mcg twice daily
2nd line
Mometasone (Asmanex) Twisthaler (PA)
440 mcg once daily
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours
prn
Medium-dose
ICS/LABA:
Mometasone/formoterol
(Dulera) 100 mcg/5 mcg
per inhalation, 2 puffs
twice daily (PA: criteria
include not well
controlled on mediumdose ICS)
High-dose ICS/LABA:
Mometasone/formoterol
(Dulera) 200 mcg/5 mcg
per inhalation, 2 puffs
twice daily (PA: criteria
include not well controlled
on medium-dose ICS)
High-dose ICS/LABA:
Mometasone/formoterol
(Dulera)
200 mcg/5 mcg per
inhalation, 2 puffs twice
daily (PA: criteria
include not well
controlled on mediumdose ICS)
2,3
Low-dose ICS/LABA
Fluticasone/salmeterol (Advair Diskus)
100 mcg/50 mcg twice daily, 12 hours
apart (PA)
or
Low-dose ICS
1st line
Beclomethasone
(QVAR) HFA/MDI w/spacer
40120 mcg twice daily
2nd line
Mometasone (Asmanex) Twisthaler (PA)
220 mcg once daily
and LTRA
Montelukast (Singulair) tablet (PA)
Age 1214 years: 5 mg daily at bedtime
Age 15 years and older: 10 mg daily at
bedtime
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours
prn
SABA
Albuterol HFA w/spacer
90 mcg/puff
2 puffs every 46 hours
prn
Medium-dose ICS
1st line
Beclomethasone (QVAR)
HFA/MDI w/spacer
120240 mcg twice daily
2nd line
Mometasone (Asmanex)
Twisthaler (PA)
440 mcg once daily
and LTRA
Montelukast (Singulair)
tablet (PA)
Age 1214 years:
5 mg daily at bedtime
Age 15 years and older:
10 mg daily at bedtime
17
Pregnancy
Inhaled corticosteroids (ICS) are the preferred medication for long-term asthma control in pregnancy. Budesonide (class B) is the preferred ICS because more data are
available on using budesonide in pregnant women than are available on other ICS, and the data are reassuring.
Other alternatives
Theophylline:
- Starting dose: 10 mg/kg/day up to 300 mg/day
- Usual maximum dose: 800 mg/day
Tiotropium: While effective for patients with COPD, is not recommended for the management of asthma
Omalizumab (Xolair): Patients on this medication, if they meet the pre-service approval criteria for office-administered injectables, are managed by Allergy and
Pulmonary.
18
Follow-up/Monitoring
To optimize treatment and prevent complications, the following periodic monitoring is advised:
Table 8. Frequency of follow-up in patients with asthma
Patients level of asthma control
Frequency
Well controlled
16 months
26 weeks
3 months
1
2
Frequency
Every visit
Comorbidity Screening
Table 10. Recommended comorbidity screening for patients with asthma
Comorbid condition
Test(s)
Depression
See the Adult Depression and Adolescent Depression guidelines for additional guidance. Patients with major
depression can be treated in primary care or offered a referral to Behavioral Health Services for counseling and/or
drug therapy.
Evidence suggests that patients with depression are less likely to be adherent to recommended management plans
and less likely to be effective at self-management.
Comorbidity Prevention
Recommend an annual flu vaccine to help patients prevent influenza.
The pneumococcal polysaccharide vaccine (PPV23) is now recommended for asthmatic patients aged
1964 (PPV23 is already recommended for all patients aged 65); see the CDC guideline at
http://www.cdc.gov/vaccines/vpd-vac/pneumo/
Asthma Diagnosis and Treatment Guideline
Copyright 19992012 Group Health Cooperative. All rights reserved.
19
Evidence Summary
Accuracy and reliability of screening and diagnostic tests
Use of spirometry in the diagnosis and initial assessment of asthma
There is fair evidence that objective assessment of pulmonary function using spirometry, in addition to the
medical history and physical examination, could improve the diagnosis of asthma and the determination
of severity in adults and children 418 years of age.
Researchers found that clinical symptoms alone underestimated spirometry-determined severity in 31%
of the children, and spirometry alone underestimated clinician-determined severity by 40% (Cowen et al
2007). An earlier study showed that 49% of the patients predicted to be abnormal with clinical evaluation
had normal spirometry, and 10% predicted to be normal clinically had abnormal spirometry (Nair et al
2005). In another study (Stout et al 2006), one-third of the children with moderate to severe asthma were
reclassified to a more severe category when pulmonary function tests were considered in addition to the
symptoms.
Impact of spirometry on management decisions
There is fair evidence that the use of spirometry has an impact on management decisions. There is,
however, insufficient evidence to determine that treatment decisions based on spirometry results reduce
morbidity and mortality due to asthma.
In Nair and colleagues 2005 study, providers made the initial treatment decisions before receiving the
pulmonary function test results. The treatment decisions were then revised, if needed, after reviewing the
results. Based on spirometry results, changes were made in the management decisions for 15% of the
patients. In these cases the provider was more likely to increase (75%) than to maintain (20%) or
decrease (5%) therapy.
Assessment of asthma control
Measures for assessing asthma control
There are multiple questionnaires for the assessment of asthma control. These include: the Asthma
Control Test (ACT), Asthma Therapy Assessment Questionnaire (ATAQ), Asthma Control Questionnaire
(ACQ), Mini Asthma Quality of Life Questionnaire, and others.
There is insufficient evidence to determine the effect of monitoring asthma patients with any of these
questionnaires on health outcomes.
There is no established gold standard for assessing asthma control, and there is insufficient evidence to
determine that one test is superior to the other in monitoring control. The majority of the questionnaires
were validated for assessing asthma control in patients with persistent asthma. However, no published
randomized controlled trials (RCTs) compared one questionnaire with the other, nor studied the effect of
monitoring asthma patients with any of these questionnaires on health outcomes.
Frequency of periodic monitoring of control
There is insufficient evidence to determine the most appropriate frequency of monitoring for asthma.
There were no published trials that compared the effect of different frequencies of visits to the clinician on
asthma control and outcomes.
Pharmacologic therapy
Comparative effectiveness and safety of montelukast (Singulair) versus inhaled corticosteroids
(ICS) in patients with mild to moderate asthma
There is evidence form a valid meta-analysis (Castro-Rodriguez 2010) of 18 RCTs (N=3,757) that
compared to montelukast, ICS leads to better asthma control and lung function, and fewer asthma
exacerbations requiring systemic steroids among school-age children and adolescents with mild to
moderate persistent asthma
20
The meta-analysis does not provide sufficient evidence to determine whether the addition of montelukast
to ICS would improve outcomes.
Step-up therapy for children with uncontrolled asthma while receiving ICS
The Best Add-on Therapy Giving Effective Responses (BADGER) trial (Lemanske 2010) evaluated the
differential response to 3 step-up therapies for children 6-17 years of age with uncontrolled mild to
moderate asthma while on low-dose inhaled corticosteroids. The study also aimed at identifying patient
characteristics that could be used to predict the response to step-up treatment.
The primary outcomes of the trial were differential response to the step-up therapies based on need for
oral prednisone for acute exacerbations, number of asthma control days, and FEV1.
The results of the study show that higher proportion had a better response to LABA than to LTRA (52%
vs. 34%, p=0.02) and a better response to LABA than to high-dose ICS (54% vs. 32%, p=0.004), without
significant differences between LTRA and high-dose ICS.
There is insufficient published evidence to determine the relative long-term safety of the three regimens.
Omalizumab
The published studies on omalizumab show that its use as an add-on therapy to steroids may have a
statistically significant but minimal and clinically irrelevant benefit over placebo in reducing asthma
exacerbations among patients with moderate to severe allergic asthma.
There is some evidence that omalizumab does not improve pulmonary function and has more treatmentrelated adverse events than placebo.
There is insufficient evidence to determine the long-term safety and efficacy of omalizumab in patients
with moderate to severe allergic asthma.
There is no evidence to determine how long treatment with omalizumab should last, and what happens if
it is discontinued.
21
References
Busse WW, Morgan WJ, Gergen PJ, et al. Randomized trial of omalizumab (anti-IgE) for asthma in innercity children. N Engl J Med. 2011 Mar 17;364(11):10051015.
Castro-Rodriguez JA, Rodrigo GJ. The role of inhaled corticosteroids and montelukast in children with
mild-moderate asthma: results of a systematic review with meta-analysis. Arch Dis Child. 2010
May;95(5):365370.
Cates CJ, Cates MJ. Regular treatment with salmeterol for chronic asthma: serious adverse events.
Cochrane Database Syst Rev. 2008;3:CD006363.
Cates CJ, Cates MJ, Lasserson TJ. Regular treatment with formoterol for chronic asthma: serious
adverse events. Cochrane Database Syst Rev. 2008;4:CD006923.
Cates CJ, Lasserson TJ, Jaeschke R. Regular treatment with salmeterol and inhaled steroids for chronic
asthma: serious adverse events. Cochrane Database Syst Rev. 2009;3:CD006922.
Cates CJ, Lasserson TJ, Jaeschke R Regular treatment with formoterol and inhaled steroids for chronic
asthma: serious adverse events. Cochrane Database Syst Rev. 2009;2:CD006924.
Cowen MK, Wakefield DB, Cloutier MM. Classifying asthma severity: objective versus subjective
measures. J Asthma. 2007 Nov;44(9):711715.
Ducharme FM, Lasserson TJ, Cates CJ. Addition to inhaled corticosteroids of long-acting beta2-agonists
versus anti-leukotrienes for chronic asthma. Cochrane Database Syst Rev. 2011;5:CD003137.
DOI:10.1002/14651858.CD003137.pub4.
Hanania NA, Alpan O, Hamilos DL, et al. Omalizumab in severe allergic asthma inadequately controlled
with standard therapy: a randomized trial. Ann Intern Med. 2011 May 3;154(9):573-582.
Kerstjens HA, Disse B, Schrder-Babo W, et al. Tiotropium improves lung function in patients with severe
uncontrolled asthma: a randomized controlled trial. J Allergy Clin Immunol. 2011 Aug;128(2):308314.
Epub 2011 Jun 2.
Lanier B, Bridges T, Kulus M, Taylor AF, Berhane I, Vidaurre CF. Omalizumab for the treatment of
exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma. J Allergy Clin
Immunol. 2009 Dec;124(6):12101216.
Lemanske RF Jr, Mauger DT, Sorkness CA, et al for the Childhood Asthma Research and Education
(CARE) Network of the National Heart, Lung, and Blood Institute. Step-up therapy for children with
uncontrolled asthma receiving inhaled corticosteroids. N Engl J Med. 2010 Mar 18;362(11):975985.
Lui AH, Zeiger RS, Sorkness CA, et al The Childhood Asthma Control Test*: Retrospective determination
and clinical validation of a cut point to identify children with very poorly controlled asthma J Allergy Clin
Immunol. 2010;126:267273.
Nair SJ, Daigle KL, DeCuir P, Lapin CD, Schramm CM. The influence of pulmonary function testing on
the management of asthma in children. J Pediatr. 2005 Dec;147(6):797801.
Peters SP, Kunselman SJ, Icitovic N, et al for the National Heart, Lung, and Blood Institute Asthma
Clinical Research Network. Tiotropium bromide step-up therapy for adults with uncontrolled asthma.
N Engl J Med. 2010 Oct 28;363(18):1715-1726.
Rodrigo GJ, Neffen H, Castro-Rodriguez JA. Efficacy and safety of subcutaneous omalizumab vs placebo
as add-on therapy to corticosteroids for children and adults with asthma: a systematic review. Chest.
2011 Jan;139(1):28-35.
Salpeter SR, Wall AJ, Buckley NS. Long-acting beta-agonists with and without inhaled corticosteroids and
catastrophic asthma events. Am J Med. 2010 Apr;123(4):322-8.e2.
Stout JW, Visness CM, Enright P, et al. Classification of asthma severity in children: the contribution of
pulmonary function testing. Arch Pediatr Adolesc Med. 2006 Aug;160(8):844850.
22
23
Side effects include the following: mood changes, acne, problems sleeping, full or red cheeks,
feeling hungrier, and gaining weight. Steroids can also make some health problems worse.
These include peptic ulcer disease, tuberculosis, glaucoma, depression, aseptic necrosis, high
blood pressure or diabetes. If you have, or have had, any of these health conditions, talk to your
doctor before taking oral steroids.
page 1 of 2
Let your doctor know if you keep going into the yellow zone. We might need to change your
controller medicines to keep your asthma under better control and avoid episodes.
Red Zone: I feel awful
This is an emergency. Your
asthma is seriously out of control.
Signs include coughing, having
trouble breathing, wheezing
loudly, or having trouble walking
or talking. If you arent wheezing,
it could be because air cant easily
move out of your airways.
Peak flow below: __________
(below 50% of personal best)
If your lips or fingernails become blue or if youre struggling to breathe, call 911 right away.
PHER
DA-3241
page 2 of 2
Enter Name
Todays Date:
Enter Address
Patients Name:
Enter City/State/Zip
Step 2 Write the number of each answer in the score box provided.
19
Very bad
Bad
Good
Very good
2. How much of a problem is your asthma when you run, exercise or play sports?
It's a big problem, I can't do what I want to do. It's a problem and I don't like it.
0
Yes, all of the time.
2
Yes, some of the time.
Not at all
1-3 days
4-10 days
11-18 days
19-24 days
Everyday
11-18 days
19-24 days
Everyday
6. During the last 4 weeks, how many days did your child wheeze during the day because of asthma?
5
Not at all
1-3 days
3
4-10 days
7. During the last 4 weeks, how many days did your child wake up during the night because of asthma?
5
Not at all
1-3 days
4-10 days
11-18 days
19-24 days
Everyday
TOTAL
Enter Address
Enter Name
Enter City/State/Zip
Enter Address
Patients Name:
Todays Date:
Patients Name:
FOR
PATIENTS:
Enter City/State/Zip
Take the Asthma Control TestTM (ACT) for people 12 yrs and older.
FOR PATIENTS:
Step 1 Write the number of each answer in the score box provided.
Know your score.
Share your results with your doctor.
1. In the past 4 weeks, how much of the time did your asthma keep you from getting as much done at work, school or at home?
All of
the time
Most of
the time
Some of
the time
A little of
the time
None of
the time
A little of
the time
None of
the time
Not at all
1
2
3
4
5
1. In the past 4 weeks, how much of the time did your asthma keep you from getting as much done at work, school or at home?
All of
Most of
Some of
3
2. During
shortness
of breath?
the time the past 14 weeks,thehow
timeoften have2you hadthe
time
More than
once a day
3 to 6 times
Once or twice
a week
More than
3 to 6 times
Once or twice
Once a day
1
2
3
a week
2. During the past 4 weeks, how often have you had shortness of breath?
SCORE
SCORE
4 or more
Once
Once
a week (wheezing,
Not at chest
all
2 asthma
3
4 of breath,
5
3. nights
Duringa week
the past 14 weeks,a how
symptoms
coughing,
tightness
weekoften did your
or twice shortness
or pain) wake you up at night or earlier than usual in the morning?
3 nights
Once
or more
Once
a week
4. 4nights
During
the past 14 weeks,2a or
how
often have2 you used
your
rescue inhaler
or nebulizer
medication
albuterol)?
Notas
at all
3
4 (such
5
week
or twice
a week
1 or 2 times
3 or more
times per day
Once a week
2 or 3 times
Not at all
1
2
3
4
5
per day
or less
per week
4. During the past 4 weeks, how often have you used your rescue inhaler or nebulizer medication (such as albuterol)?
1 or 2 times
2 or 3 times
or more
5. 3times
How
would
you rate
asthma
control 2during the
past 4 weeks?3
1 yourper
day
per week
per day
Poorly
controlled
Not controlled
at all
Somewhat
controlled
1
2
3
5. How would you rate your asthma control during the past 4 weeks?
Not controlled
at all
Poorly
controlled
Somewhat
controlled
Once a week
or less
Well
controlled
Not at all
Completely
controlled
Well
controlled
Completely
controlled
TOTAL
TOTAL
If your score is 19 or less, your asthma may not be controlled as well as it could be.
Talk to your doctor.
If your score is 19 or less, your asthma may not be controlled as well as it could be.
FOR PHYSICIANS:
Talk to your doctor.
The ACT is:
Recognized by the National Institutes of Health
FOR
PHYSICIANS:
A simple,
5-question tool that is self-administered by the patient
Clinically
validated by specialist assessment and spirometry1
The
ACT is:
A simple, 5-question tool that is self-administered by the patient
Clinically validated by specialist assessment and spirometry1
Reference: 1. Nathan RA et al. J Allergy Clin Immunol. 2004;113:59-65.
Asthma Control Test. AsthmaControl.com. GlaxoSmithKline, 2002. Web. 9 Apr 2010.
<http://www.asthmacontrol.com/hcp.html>.
Reference: 1. Nathan RA et al. J Allergy Clin Immunol. 2004;113:59-65.
DA-3320 -1 Rev. Date 2010105