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Guidelines from the National Asthma Education
and Prevention Program
The goal of this asthma care quick
reference guide is to help clinicians
provide quality care to people who
have asthma.
Quality asthma care involves not only initial diagnosis and
treatment to achieve asthma control, but also long-term,
regular follow-up care to maintain control.
Asthma control focuses on two domains: (1) reducing
impairment —the frequency and intensity of symptoms and
functional limitations currently or recently experienced by a
patient; and (2) reducing risk —the likelihood of future asthma
attacks, progressive decline in lung function (or, for children,
reduced lung growth), or medication side effects.
Achieving and maintaining asthma control requires providing
appropriate medication, addressing environmental factors
that cause worsening symptoms, helping patients learn self-
management skills, and monitoring over the long term to
assess control and adjust therapy accordingly.
The diagram (right) illustrates the steps involved in providing
quality asthma care.
INITIAL VISIT
Diagnose asthma
Schedule follow-up appointment
Develop written asthma action plan
Initiate medication & demonstrate use
Assess asthma severity
Assess & monitor
asthma control
Schedule next
follow-up
appointment
Review asthma
action plan, revise
as needed
Maintain, step
up, or step down
medication
Review medication
technique &
adherence; assess
side effects; review
environmental control
FOLLOW-UP VISITS
EXPERT PANEL REPORT 3
This guide summarizes recommendations developed by the
National Asthma Education and Prevention Program’s expert panel
after conducting a systematic review of the scientific literature on
asthma care. See www.nhlbi.nih.gov/guidelines/asthma for the full
report and references. Medications and dosages were updated in
September 2011 for the purposes of this quick reference guide to
reflect currently available asthma medications.
Asthma Care
Quick Reference
DIAGNOSING AND MANAGING ASTHMA
KEY CLINICAL ACTIVITIES FOR QUALITY ASTHMA CARE
(See complete table in Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma [EPR-3])
Clinical Issue Key Clinical Activities and Action Steps
ASTHMA DIAGNOSIS
Establish asthma diagnosis.
Determine that symptoms of recurrent airway obstruction are present, based on history
and exam.
- History of cough, recurrent wheezing, recurrent difficulty breathing, recurrent
chest tightness
- Symptoms occur or worsen at night or with exercise, viral infection, exposure to allergens
and irritants, changes in weather, hard laughing or crying, stress, or other factors
In all patients ≥5 years of age, use spirometry to determine that airway obstruction is at
least partially reversible.
Consider other causes of obstruction.
LONG-TERM ASTHMA MANAGEMENT
GOAL:
Asthma Control
Reduce Impairment
Prevent chronic symptoms.
Require infrequent use of short-acting beta
2
-agonist (SABA).
Maintain (near) normal lung function and normal activity levels.
Reduce Risk
Prevent exacerbations.
Minimize need for emergency care, hospitalization.
Prevent loss of lung function (or, for children, prevent reduced lung growth).
Minimize adverse effects of therapy.
Assessment
and Monitoring
INITIAL VISIT: Assess asthma severity to initiate treatment (see page 5).
FOLLOW-UP VISITS: Assess asthma control to determine if therapy should be adjusted
(see page 6).
Assess at each visit: asthma control, proper medication technique, written asthma action
plan, patient adherence, patient concerns.
Obtain lung function measures by spirometry at least every 1–2 years; more frequently for
asthma that is not well controlled.
Determine if therapy should be adjusted: Maintain treatment; step up, if needed; step
down, if possible.
Schedule follow-up care.
Asthma is highly variable over time. See patients:
- Every 2–6 weeks while gaining control
- Every 1–6 months to monitor control
- Every 3 months if step down in therapy is anticipated
Use of
Medications
Select medication and delivery devices that meet patient’s needs and circumstances.
Use stepwise approach to identify appropriate treatment options (see page 7).
Inhaled corticosteroids (ICSs) are the most effective long-term control therapy.
When choosing treatment, consider domain of relevance to the patient (risk, impairment,
or both), patient’s history of response to the medication, and willingness and ability to use
the medication.
Review medications, technique, and adherence at each follow-up visit.
ASTHMA CARE FOR SPECIAL CIRCUMSTANCES
Clinical Issue Key Clinical Activities and Action Steps
Exercise-Induced
Bronchospasm
Prevent EIB. *
Physical activity should be encouraged. For most patients, EIB should not limit
participation in any activity they choose.
Teach patients to take treatment before exercise. SABAs* will prevent EIB in most patients;
LTRAs,* cromolyn, or LABAs* also are protective. Frequent or chronic use of LABA to
prevent EIB is discouraged, as it may disguise poorly controlled persistent asthma.
Consider long-term control medication. EIB often is a marker of inadequate asthma control
and responds well to regular anti-inflammatory therapy.
Encourage a warm-up period or mask or scarf over the mouth for cold-induced EIB.
Pregnancy Maintain asthma control through pregnancy.
Check asthma control at all prenatal visits. Asthma can worsen or improve during
pregnancy; adjust medications as needed.
Treating asthma with medications is safer for the mother and fetus than having poorly
controlled asthma. Maintaining lung function is important to ensure oxygen supply to the fetus.
ICSs* are the preferred long-term control medication.
Remind patients to avoid exposure to tobacco smoke.
MANAGING EXACERBATIONS
Clinical Issue Key Clinical Activities and Action Steps
Home Care
Develop a written asthma action plan (see Patient Education for Self-Management, page 3).
Teach patients how to:
Recognize early signs, symptoms, and PEF* measures that indicate worsening asthma.
Adjust medications (increase SABA* and, in some cases, add oral systemic corticosteroids)
and remove or withdraw from environmental factors contributing to the exacerbation.
Monitor response.
Seek medical care if there is serious deterioration or lack of response to treatment.
Give specific instructions on who and when to call.
Urgent or
Emergency Care
Assess severity by lung function measures (for ages ≥ 5 years), physical examination, and
signs and symptoms.
Treat to relieve hypoxemia and airflow obstruction; reduce airway inflammation.
Use supplemental oxygen as appropriate to correct hypoxemia.
Treat with repetitive or continuous SABA,* with the addition of inhaled ipratropium
bromide in severe exacerbations.
Give oral systemic corticosteroids in moderate or severe exacerbations or for patients who
fail to respond promptly and completely to SABA.
Consider adjunctive treatments, such as intravenous magnesium sulfate or heliox, in severe
exacerbations unresponsive to treatment.
Monitor response with repeat assessment of lung function measures, physical
examination, and signs and symptoms, and, in emergency department, pulse oximetry.
Discharge with medication and patient education:
Medications: SABA, oral systemic corticosteroids; consider starting ICS*
Referral to follow-up care
Asthma discharge plan
Review of inhaler technique and, whenever possible, environmental control measures
Abbreviations: EIB, exercise-induced bronchospasm; ICS, inhaled corticosteroid; LABA, long-acting beta
2
-agonist; LTRA, leukotriene receptor
antagonist; PEF, peak expiratory flow; SABA, short-acting beta 2
-agonist.
INITIAL VISIT:
CLASSIFYING ASTHMA SEVERITY AND INITIATING THERAPY
(in patients who are not currently taking long-term control medications) Level of severity (Columns 2–5) is determined by events listed in Column 1 for both impairment (frequency and intensity of symptoms and functional limitations) and risk (of exacerbations). Assess impairment by patient’s or caregiver’s recall of events during the previous 2–4 weeks; assess risk over the last year. Recommendations for initiating therapy based on level of severity are presented in the last row.
Components of
Severity
Intermittent
Persistent
Mild
Moderate
Severe
Ages
0–4 years
Ages
5–11 years
Ages
12 years
Ages
0–4 years
Ages
5–11 years
Ages
12 years
Ages
0–4 years
Ages
5–11 years
Ages
12 years
Ages
0–4 years
Ages
5–11 years
Ages
12 years
Impairment
Symptoms
2 days/week
2 days/week but not daily
Daily
Throughout the day
Nighttime awakenings
2x/month
1–2x/month
3–4x/month
3–4x/month
1x/week but not nightly
1x/week
Often 7x/week
SABA
use for
symptom control (not to prevent EIB
2 days/week
2 days/week
but not daily
2 days/week but
not daily and not more
than once on any day
Daily
Several times per day
Interference with normal activity
None
Minor limitation
Some limitation
Extremely limited
Lung function
FEV
1
(% predicted)
FEV
1
/FVC
Not
applicable
Normal FEV
1
between
exacerbations
Normal FEV
1
between
exacerbations
Normal
Not
applicable
Normal
Not
applicable
Reduced 5%
Not
applicable
Reduced >5%
Risk
Asthma exacerbations requiring oral systemic corticosteroids
0–1/year
2 exacerb.
in 6 months, or wheezing
4x
per
year lasting
1 day
AND risk
factors for persistent
asthma
2/year
Consider severity and interval since last asthma exacerbation. Frequency and severity may fluctuate over time for patients in any severity category.
Relative annual risk of exacerbations may be related to FEV
1
Recommended Step for Initiating Therapy (See “Stepwise Approach for Managing Asthma Long Term,” page 7) The stepwise approach is meant to help, not replace, the clinical decisionmaking needed to meet individual patient needs.
Step 1
Step 2
Step 3
Step 3
medium-dose
ICS
option
Step 3
Step 3
Step 3
medium-dose
ICS
option
or Step 4
Step 4
or 5
Consider short course of oral systemic corticosteroids.
In 2–6 weeks, depending on severity, assess level of asthma control achieved and adjust therapy as needed.
For children 0–4 years old, if no clear benefit is observed in 4–6 weeks, consider adjusting therapy or alternate diagnoses.
Abbreviations:
EIB, exercise-induced bronchospam; FEV
1
, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroid; SABA, short-acting beta
2
-agonist.
Normal FEV
1
/FVC by age: 8–19 years, 85%; 20–39 years, 80%; 40–59 years, 75%; 60–80 years, 70%.
Data are insufficient to link frequencies of exacerbations with different levels of asthma severity. Generally, more frequent and intense exacerbations (e.g., requiring urgent care, hospital or intensive care admission, and/or oral corticosteroids) indicate greater underlying disease severity. For treatment purposes, patients with
≥
2 exacerbations may be considered to have persistent asthma, even in the absence of impairment levels consistent with persistent asthma.
Generally, more frequent and intense events indicate greater severity.
Generally, more frequent and intense events indicate greater severity.
STEPWISE APPROACH FOR MANAGING ASTHMA LONG TERM
The stepwise approach tailors the selection of medication to the level of asthma severity (see page 5) or asthma control (see page 6).
The stepwise approach is meant to help, not replace, the clinical decisionmaking needed to meet individual patient needs.
At each step: Patient education, environmental control, and management of comorbidities
0–4 years of age
Intermittent
Asthma
Persistent Asthma: Daily Medication
Consult with asthma specialist if step 3 care or higher is required. Consider consultation at step 2.
Preferred
Treatment
SABA as
needed
low-dose ICS medium-dose
ICS
medium-dose
ICS
either LABA or
montelukast
high-dose ICS
either LABA or
montelukast
high-dose ICS
either LABA or
montelukast
oral corticosteroids
Alternative
Treatment
,
‡
cromolyn or
montelukast
If clear benefit is not observed in 4–6 weeks, and medication technique and adherence are satisfactory,
consider adjusting therapy or alternate diagnoses.
Quick-Relief
Medication
SABA as needed for symptoms; intensity of treatment depends on severity of symptoms.
With viral respiratory symptoms: SABA every 4–6 hours up to 24 hours (longer with physician consult). Consider short
course of oral systemic corticosteroids if asthma exacerbation is severe or patient has history of severe exacerbations.
Caution: Frequent use of SABA may indicate the need to step up treatment.
5–11 years of age
Intermittent
Asthma
Persistent Asthma: Daily Medication
Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3.
Preferred
Treatment
SABA as needed low-dose ICS low-dose ICS
either LABA,
LTRA, or
theophylline
(b)
OR
medium-dose
ICS
medium-dose
ICS
LABA
high-dose ICS
LABA
high-dose ICS
LABA
oral corticosteroids
Alternative
Treatment
,
‡
cromolyn, LTRA,
or theophylline
§
medium-dose ICS
either LTRA or
theophylline
§
high-dose ICS
either LTRA or
theophylline
§
high-dose ICS
either LTRA or
theophylline
§
oral corticosteroids
Consider subcutaneous allergen immunotherapy for
patients who have persistent, allergic asthma.
Quick-Relief
Medication
SABA as needed for symptoms. The intensity of treatment depends on severity of symptoms: up to 3 treatments
every 20 minutes as needed. Short course of oral systemic corticosteroids may be needed.
Caution: Increasing use of SABA or use >2 days/week for symptom relief (not to prevent EIB ) generally indicates
inadequate control and the need to step up treatment.
12 years of age
Intermittent
Asthma
Persistent Asthma: Daily Medication
Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3.
Preferred
Treatment
†
SABA as needed low-dose ICS low-dose ICS
LABA
OR
medium-dose ICS
medium-dose
ICS
LABA
high-dose ICS
LABA
AND
consider
omalizumab for
patients who
have allergies
high-dose ICS
LABA
oral
corticosteroid
§§
AND
consider
omalizumab for
patients who
have allergies
Alternative
Treatment
, ‡
cromolyn, LTRA,
or theophylline
§
low-dose ICS
either LTRA,
theophylline,
§
or zileuton
medium-dose ICS
either LTRA,
theophylline,
§
or zileuton
Consider subcutaneous allergen immunotherapy
for patients who have persistent, allergic asthma.
Quick-Relief
Medication
SABA as needed for symptoms. The intensity of treatment depends on severity of symptoms: up to 3 treatments
every 20 minutes as needed. Short course of oral systemic corticosteroids may be needed.
Caution: Use of SABA >2 days/week for symptom relief (not to prevent EIB ) generally indicates inadequate control
and the need to step up treatment.
Abbreviations: EIB, exercise-induced bronchospasm; ICS, inhaled corticosteroid; LABA, inhaled long-acting beta 2
-agonist; LTRA, leukotriene receptor antagonist; SABA, inhaled
short-acting beta 2
-agonist.
† Treatment options are listed in alphabetical order, if more than one.
If alternative treatment is used and response is inadequate, discontinue and use preferred treatment before stepping up.
§ Theophylline is a less desirable alternative because of the need to monitor serum concentration levels.
Based on evidence for dust mites, animal dander, and pollen; evidence is weak or lacking for molds and cockroaches. Evidence is strongest for immunotherapy with single allergens.
The role of allergy in asthma is greater in children than in adults.
Clinicians who administer immunotherapy or omalizumab should be prepared to treat anaphylaxis that may occur.
Zileuton is less desirable because of limited studies as adjunctive therapy and the need to monitor liver function.
§§ Before oral corticosteroids are introduced, a trial of high-dose ICS + LABA + either LTRA, theophylline, or zileuton, may be considered, although this approach has not been studied
in clinical trials.
ASSESS
CONTROL:
STEP UP IF NEEDED (first, check medication adherence, inhaler technique, environmental control, and comorbidities)
STEP DOWN IF POSSIBLE (and asthma is well controlled for at least 3 months)
STEP 1
STEP 6
STEP 5
STEP 4
STEP 3
STEP 2
ESTIMATED COMPARATIVE DAILY DOSAGES:
INHALED CORTICOSTEROIDS FOR LONG-TERM ASTHMA CONTROL
0–4 years of age
5–11 years of age
12 years of age
Daily Dose
Low
Medium
High
Low
Medium
High
Low
Medium
High
MEDICATION Beclomethasone MDI
40 mcg/puff 80 mcg/puff
N/A
N/A
N/A
80–160 mcg
1–2 puffs
2x/day
1 puff 2x/day
160–320 mcg
3–4 puffs
2x/day
2 puffs 2x/day
320 mcg
3 puffs 2x/day
80–240 mcg
1–3 puffs
2x/day
1 puff am,
2 puffs pm
240–480 mcg
4–6 puffs
2x/day
2–3 puffs
2x/day
480 mcg
4 puffs
2x/day
Budesonide DPI
90 mcg/inhalation 180 mcg/ inhalation
N/A
N/A
N/A
180–360 mcg
1–2 inhs
2x/day
360–720 mcg 3–4 inhs
2x/day
2 inhs
2x/day
720 mcg
3 inhs
2x/day
180–540 mcg
1–3 inhs
2x/day
1 inh
am,
2 inhs
pm
540–1,080 mcg 2–3 inhs
2x/day
1,080 mcg
4 inhs
2x/day
Budesonide Nebules 0.25 mg 0.5 mg 1.0 mg
0.25–0.5 mg
1–2 nebs
/day
1 neb
/day
0.5–1.0 mg 2 nebs
/day
1 neb
/day
1.0 mg
3 nebs
/day
2 nebs
/day
0.5 mg
1 neb
2x/day
1 neb
/day
1.0 mg
1 neb
2x/day
1 neb
/day
2.0 mg
1 neb
2x/day
N/A
N/A
N/A
Ciclesonide MDI
80 mcg/puff 160 mcg/puff
N/A
N/A
N/A
80–160 mcg
1–2 puffs/day
1 puff/day
160–320 mcg
1 puff am,
2 puffs pm–
2 puffs 2x/day
1 puff 2x/day
320 mcg
3 puffs 2x/day
2 puffs 2x/day
160–320 mcg
1–2 puffs 2x/day
320–640 mcg 3–4 puffs 2x/day
2 puffs 2x/day
640 mcg
3 puffs 2x/day
Flunisolide MDI
80 mcg/puff
N/A
N/A
N/A
160 mcg
1 puff 2x/day
320–480 mcg
2–3 puffs 2x/day
480 mcg
4 puffs 2x/day
320 mcg
2 puffs 2x/day
320–640 mcg 3–4 puffs 2x/day
640 mcg
5 puffs 2x/day
It is preferable to use a higher mcg/puff or mcg/inhalation formulation to achieve as low a number of puffs or inhalations as possible.
Abbreviations:
DPI, dry powder inhaler (requires deep, fast inhalation); inh, inhalation; MDI, metered dose inhaler (releases a puff of medication); neb, nebule.
USUAL DOSAGES FOR OTHER LONG-TERM CONTROL MEDICATIONS*
Medication 0–4 years of age 5–11 years of age ≥ 12 years of age
Combined Medication (inhaled corticosteroid + long-acting beta
2
-agonist)
Fluticasone/Salmeterol —
DPI
100 mcg/50 mcg, 250 mcg/50 mcg, or
500 mcg/50 mcg
MDI
45 mcg/21 mcg, 115 mcg/21 mcg, or
230 mcg/21 mcg
Budesonide/Formoterol —
MDI
80 mcg/4.5 mcg or 160 mcg/4.5 mcg
Mometasone/Formoterol —
MDI
100 mcg/5 mcg
N/A
N/A
N/A
1 inhalation 2x/day; dose
depends on level of
severity or control
2 puffs 2x/day; dose
depends on level of
severity or control
N/A†
1 inhalation 2x/day; dose
depends on level of severity
or control
2 puffs 2x/day; dose depends
on level of severity or control
2 inhalations 2x/day; dose
depends on severity of asthma
Leukotriene Modifiers
Leukotriene Receptor Antagonists (LTRAs)
Montelukast — 4 mg or 5 mg chewable tablet,
4 mg granule packets, 10 mg tablet
Zafirlukast — 10 mg or 20 mg tablet
Take at least 1 hour before or 2 hours after a meal.
Monitor liver function.
5-Lipoxygenase Inhibitor
Zileuton — 600 mg tablet
Monitor liver function.
4 mg every night at
bedtime (1–5 years of age)
N/A
N/A
5 mg every night at
bedtime (6–14 years of age)
10 mg 2x/day
(7–11 years of age)
N/A
10 mg every night at
bedtime
40 mg daily
(20 mg tablet 2x/day)
2,400 mg daily
(give 1 tablet 4x/day)
Immunomodulators
Omalizumab (Anti IgE
Subcutaneous injection, 150 mg/1.2 mL following
reconstitution with 1.4 mL sterile water for injection
Monitor patients after injections; be prepared to treat
anaphylaxis that may occur.
N/A
N/A
150–375 mg subcutaneous
every 2–4 weeks, depending
on body weight and
pretreatment serum IgE level
Cromolyn
Cromolyn — Nebulizer: 20 mg/ampule 1 ampule 4x/day, N/A
<2 years of age
1 ampule 4x/day 1 ampule 4x/day
Methylxanthines
Theophylline —
Liquids, sustained-release tablets, and capsules
Monitor serum concentration levels.
Starting dose 10 mg/kg/
day; usual maximum:
<1 year of age: 0.2 (age in
weeks) + 5 = mg/kg/day
≥1 year of age:
16 mg/kg/day
Starting dose 10 mg/
kg/day; usual maximum:
16 mg/kg/day
Starting dose 10 mg/kg/day
up to 300 mg maximum;
usual maximum:
800 mg/day
Inhaled Long-Acting Beta
2
-Agonists (LABAs) – used in conjunction with ICS
for long-term control; LABA is NOT to be used as monotherapy
Salmeterol — DPI
50 mcg/blister
Formoterol —DPI
12 mcg/single-use capsule
N/A
N/A
1 blister every 12 hours
1 capsule every 12 hours
1 blister every 12 hours
1 capsule every 12 hours
Oral Systemic Corticosteroids
Methylprednisolone — 2, 4, 8, 16, 32 mg tablets
Prednisolone — 5 mg tablets; 5 mg/5 cc, 15 mg/5 cc
Prednisone — 1, 2.5, 5, 10, 20, 50 mg tablets;
5 mg/cc, 5 mg/5 cc
0.25–2 mg/kg daily
in single dose in a.m.
or every other day as
needed for control
Short course “burst”:
1–2 mg/kg/day, max 60
mg/d for 3–10 days
0.25–2 mg/kg daily
in single dose in a.m.
or every other day as
needed for control
Short course “burst”:
1–2 mg/kg/day, max 60
mg/d for 3–10 days
7.5–60 mg daily in single
dose in a.m. or every other
day as needed for control
Short course “burst”: to
achieve control, 40–60 mg/
day as single or 2 divided
doses for 3–10 days
- Dosages are provided for those products that have been approved by the U.S. Food and Drug Administration or have sufficient clinical trial safety and efficacy data in the
appropriate age ranges to support their use.
† Abbreviations: DPI, dry powder inhaler; IgE, immunoglobulin E; MDI, metered-dose inhaler; N/A, not available (not approved, no data available, or safety and efficacy not
established for this age group).
The most important determinant of appropriate dosing is the clinician’s judgment of the patient’s response to therapy. The clinician
must monitor the patient’s response on several clinical parameters (e.g., symptoms; activity level; measures of lung function) and adjust
the dose accordingly. Once asthma control is achieved and sustained at least 3 months, the dose should be carefully titrated down to the
minimum dose necessary to maintain control.
RESPONDING TO PATIENT QUESTIONS ABOUT INHALED CORTICOSTEROIDS
Questions and varying beliefs about inhaled
corticosteroids (ICSs) are common and may affect
adherence to treatment. Following are some key
points to share with patients and families.
ICSs are the most effective medications for
long-term control of persistent asthma. Because
ICSs are inhaled, they go right to the lungs to
reduce chronic airway inflammation. In general,
ICSs should be taken every day to prevent asthma
symptoms and attacks.
The potential risks of ICSs are well balanced by their
benefits. To reduce the risk of side effects, patients
should work with their doctor to use the lowest dose
that maintains asthma control, and be sure to take the
medication correctly.
- Mouth irritation and thrush (yeast infection),
which may be associated with ICSs at higher
doses, can be avoided by rinsing the mouth and
spitting after ICS use and, if appropriate for the
inhaler device, by using a valved holding chamber
or spacer.
- ICS use may slow a child’s growth rate slightly.
This effect on linear growth is not predictable and
is generally small (about 1 cm), appears to occur
in the first several months of treatment, and is
not progressive. The clinical significance of this
potential effect has yet to be determined. Growth
rates are highly variable in children, and poorly
controlled asthma can slow a child’s growth.
ICSs are generally safe for pregnant women.
Controlling asthma is important for pregnant women
to be sure the fetus receives enough oxygen.
ICSs are not addictive.
ICSs are not the same as anabolic steroids that some
athletes use illegally to increase sports performance.
RESPONDING TO PATIENT QUESTIONS ABOUT LONG-ACTING BETA
2
-AGONISTS
Keep the following key points in mind when
educating patients and families about long-acting
beta
2
-agonists (LABAs).
The addition of LABA (salmeterol or formoterol) to the
treatment of patients who require more than low-dose
inhaled corticosteroid (ICS) alone to control asthma
improves lung function, decreases symptoms, and
reduces exacerbations and use of short-acting
beta
2
-agonists (SABA) for quick relief in most patients
to a greater extent than doubling the dose of ICS.
A large clinical trial found that slightly more deaths
occurred in patients taking salmeterol in a single
inhaler every day in addition to usual asthma therapy*
(13 out of about 13,000) compared with patients taking
a placebo in addition to usual asthma therapy
(3 out of about 13,000). Trials for formoterol in a
single inhaler every day in addition to usual therapy*
found more severe asthma exacerbations in patients
taking formoterol, especially at higher doses, compared
with those taking a placebo added to usual therapy.
Therefore, the Food and Drug Administration placed
a Black Box warning on all drugs containing a LABA.
The established benefits of LABAs added to ICS for the
great majority of patients who require more than low-
dose ICS alone to control asthma should be weighed
against the risk of severe exacerbations, although
uncommon, associated with daily use of LABAs.
LABAs should not be used as monotherapy for
long-term control. Even though symptoms may
improve significantly, it is important to keep taking
ICS while taking LABA.
Daily use should generally not exceed 100 mcg
salmeterol or 24 mcg formoterol.
It is not currently recommended that LABAs be used
to treat acute symptoms or exacerbations.
Usual therapy included a wide range of regimens, from those in which no other daily therapy was taken to those in which varying doses of other daily medications were taken.
