recommendations can be tentatively applied to other commonly prescribed ICS .
For children 0-4 years of age with recurrent wheezing triggered only by respiratory tract infections ( intermittent or Step 1 ), the Expert Panel recommends a short course of twice-daily , high-dose ICS for seven to 10 days at the onset of a respiratory tract infection , with albuterol as needed for quick relief therapy . This recommendation applies to children who have had three or more episodes of wheezing triggered by respiratory tract infections in their lifetime or two episodes in the past year and are asymptomatic between episodes . The main benefit found in studies of intermittent ICS use during respiratory tract infections is a reduction in exacerbations requiring systemic corticosteroids compared to as-needed albuterol alone ( 33 % relative risk reduction ). 1 Of note , the evidence review found conflicting data on ICS effects on growth . Bacharier et al . found no effect of budesonide inhalation suspension ( 1 mg twice daily for seven days ) on linear growth compared to placebo , while Ducharme et al . noted a 5 % lower gain in height and weight for study participants receiving intermittent fluticasone ( 750 mcg twice daily at onset of a respiratory tract infection for up to 10 days ). 1 The Expert Panel recommends that clinicians consider and discuss growth concerns with parents when implementing this guideline recommendation as a part of shared decision making .
For patients 12 years and older classified with mild persistent asthma ( Step 2 ), the Expert Panel recommends daily low-dose ICS with as-needed albuterol as the preferred treatment or intermittent , low-dose ICS with concomitant as-needed albuterol , considering both treatment options to be of equal effectiveness . For example , if intermittent ICS therapy is chosen , the approach in three of the four studies assessed by the panel recommend two to four puffs of albuterol followed by 80-250 microgram of beclomethasone equivalent every four hours as needed . 1 , 2 For example , if a patient requires albuterol due to acute asthma symptoms , he / she could also inhale two puffs of ICS following the albuterol dose . When determining which of these treatment regimens to implement , individual patient factors should be considered , and shared-decision making with the patient / family should take place .
For patients aged 4 years and older with mild to moderate persistent asthma who are
Revised Step-wise Treatment Regimens for ICS and ICS-LABA
Step-wise Therapy
Step 1 ( reliever )
Step 2 ( reliever )
Step 3 ( maintenance )
Step 3 ( reliever ) ( SMART )
Step 4 ( maintenance )
Step 4 ( reliever ) ( SMART )
0 - 4 years old 4 - 11 years old 12 + years old
Budesonide inhalation suspension , 1 mg , twice daily for 7 to 10 days at onset of respiratory tract infection + albuterol prn
currently taking daily ICS and demonstrate good adherence , the Expert Panel recommends against a short-term increase in the ICS dose for increased symptoms or decreased peak flow , due to lack of efficacy . However , if ICS adherence is less assured , a short-term increase may be appropriate , and may involve doubling , quadrupling , or even quintupling the prescribed daily dose . 1 , 2
ICS-LABA
Single maintenance and reliever therapy ( SMART ) implementation for patients aged 4 years and older with moderate to severe asthma ( Step 3 or 4 ) is a significant revision to the asthma management guidelines . The Expert Panel strongly recommends SMART implementation , utilizing ICS-formoterol in a single inhaler as both daily control and quick-relief therapy . In terms of the stepwise management , low-dose ICS-formoterol should be preferred for Step 3 therapy and medium-dose ICS-formoterol for Step 4 ( Table 2 ). As a reliever therapy , 1-2 puffs ICS-formoterol ( 4.5 mcg formoterol / puff ) every four hours can be used as needed up to a maximum total daily maintenance and rescue dose
2-4 puffs of albuterol followed by 80-250 mcg beclomethasone equivalent ICS every 4 hours as needed ( ICS dosing determined by healthcare provider )
1-2 puffs of low-dose ICS + formoterol daily or twice daily
1-2 puffs low-dose budesonide + formoterol ( 4.5 mcg formoterol / puff ) every 4 hours as needed ( maximum daily total of 8 puff )
1-2 puffs low-dose budesonide + formoterol ( 4.5 mcg formoterol / puff ) every 4 hours as needed ( maximum daily total of 12 puffs )
1-2 puffs of medium-dose ICS + formoterol daily or twice daily
1-2 puffs medium-dose budesonide + formoterol ( 4.5 mcg formoterol / puff ) every 4 hours as needed ( maximum daily total of 8 puffs )
1-2 puffs medium-dose budesonide + formoterol ( 4.5 mcg formoterol / puff ) every 4 hours as needed ( maximum daily total of 12 puffs )
Table 2 . Step-wise treatment regimens for ICS and ICS-LABA during respiratory infections , intermittent dosing , rescue therapy , and maintenance . of eight puffs ( 4-11 years of age ) or 12 puffs ( 12 + years of age ). 2 The recommendation for formoterol as the preferred long-acting beta agonist is due to its rapid onset and ability to be given greater than twice daily . Collectively , SMART showed a 32 % reduction in asthma exacerbations requiring unscheduled medical visits or systemic corticosteroids . 1 In some studies , asthma control and quality of life also improved with SMART , and no differences in potential adverse effects between SMART and previously recommended management ( ICS-alone or ICS-LABA ) were noted . 1 We stress that these recommendations are unique to formoterol and should not be applied to other LABAs . LABAs without ICS is not recommended as a reliever medication for asthma symptoms .
On July 21 , 2021 , the Arkansas Medicaid Drug Utilization Review Board approved the implementation of SMART therapy without restriction for patients 4 years and older who have a diagnosis of asthma . Dulera and Symbicort are approved , including two inhalers dispensed per month . Prior authorization will be required
( Continued on page 166 )
Volume 118 • Number 7 JANUARY 2022 • 165