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Approaches to asthma controller therapy in adolescents and adults

National Asthma Education and Prevention Program: Expert Panel Working Group (NAEPP 2020)		Global Initiative for Asthma (GINA)
Asthma symptoms/lung function	Therapy*	Asthma symptoms	Therapy
Intermittent asthma/step 1		Step 1
Daytime symptoms ≤2 days/week Nocturnal awakenings ≤2/month Normal FEV₁ Exacerbations ≤1/year	SABA, as needed	Infrequent asthma symptoms (eg, <2 times/week)	Low-dose ICS with rapid onset LABA (eg, budesonide-formoterol combination MDI 160 mcg-4.5 mcg/inhalation or DPI 200 mcg-6 mcg/inhalation) 1 inhalation, as needed (preferred) or Low-dose ICS whenever SABA used
Mild persistent asthma/step 2		Step 2
Daytime symptoms >2 but <7 days/week Nocturnal awakenings 3 to 4 nights/month Minor interference with activities FEV₁ within the normal range Exacerbations ≥2/year	Low-dose ICS daily and SABA as needed or Low-dose ICS plus SABA, concomitantly administered, as needed Alternative option(s) Daily LTRA and SABA as needed	Asthma symptoms or need for reliever inhaler ≥2 times/week	Low-dose ICS-formoterol as needed (preferred) or Low-dose ICS daily and SABA as needed Other options Low-dose ICS plus SABA, concomitantly administered, as needed or (less preferred) LTRA daily and SABA as needed
Moderate persistent asthma/step 3		Step 3
Daily symptoms Nocturnal awakenings >1/week Daily need for SABA Some activity limitation FEV₁ 60 to 80% predicted Exacerbations ≥2/year	Combination low-dose ICS-formoterol daily and 1 to 2 inhalations as needed up to 12 inhalations/day (preferred option) Alternative option(s) Medium-dose ICS daily and SABA as needed or Low-dose ICS-LABA combination daily or low-dose ICS plus LAMA daily or low-dose ICS plus LTRA daily and SABA as needed or Low-dose ICS daily plus zileuton and SABA as needed	Troublesome asthma symptoms most days, nocturnal awakening due to asthma ≥1 time/month, risk factors for exacerbations^¶	Low-dose ICS-formoterol as maintenance and reliever therapy (ie, budesonide-formoterol) (preferred) or Low-dose ICS-LABA combination daily and SABA as needed Other options Medium-dose ICS daily and SABA as needed or Low-dose ICS plus LTRA daily and SABA as needed
Severe persistent asthma/steps 4 to 6		Steps 4 to 5
Symptoms all day Nocturnal awakenings nightly Need for SABA several times/day Extreme limitation in activity FEV₁ <60% predicted Exacerbations ≥2/year	Step 4: Combination medium dose ICS-formoterol daily and 1 to 2 inhalations as needed to 12 inhalations/day (preferred option) Alternative option(s) Medium-dose ICS-LABA daily or medium-dose ICS plus LAMA daily and SABA as needed or Medium-dose ICS daily plus LTRA or zileuton and SABA as needed*	Severely uncontrolled asthma with ≥3 of the following: daytime asthma symptoms >2 times/week; nocturnal awakening due to asthma; reliever needed for symptoms >2 times/week, or activity limitation due to asthma or An acute exacerbation	Step 4: Medium-dose ICS-formoterol as maintenance and reliever therapy (preferred) or Medium dose ICS-LABA daily and SABA as needed Other options Possible add-on LAMA or switch to ICS-LAMA-LABA Possible add-on LTRA High-dose ICS-LABA trial (3 to 6 months) if other add-ons insufficient – May need short course of oral glucocorticoids
	Step 5: Medium to high-dose ICS-LABA plus LAMA daily and SABA as needed (preferred) Alternative option(s) Medium-high dose ICS-LABA daily or high-dose ICS + LTRA* daily and SABA as needed Possible addition of asthma biologics^Δ		Step 5: Medium-dose ICS-formoterol as maintenance and reliever therapy plus LAMA daily (preferred) or Medium-dose ICS-LABA plus LAMA daily and SABA as needed Assess asthma phenotype and evaluate for possible addition of asthma biologics^Δ Other options High-dose ICS-LABA trial (3 to 6 months) Possible add-on LTRA or azithromycin Oral glucocorticoids titrated to optimize asthma control and minimize adverse effects
	Step 6: High-dose ICS-LABA daily; consider LAMA as substitute for LABA or as add-on therapy if not done previously^◊ Oral glucocorticoids, titrated to optimize asthma control and minimize adverse effects Possible addition of asthma biologics^Δ

Initial therapies are noted above. A higher level of initial therapy, sometimes with concurrent use of oral glucocorticoids, may be chosen if the patient presents with an acute exacerbation. Treatment may be stepped down if asthma is well controlled for at least three months, or stepped up 1 or 2 steps if asthma is not well controlled or is very poorly controlled. At follow-up visits, check adherence, inhaler technique, environmental factors, and comorbid conditions. Subcutaneous immunotherapy is suggested as an adjunct to standard pharmacotherapy in individuals who have demonstrated allergy to the included allergens and whose asthma is well-controlled whenever immunotherapy is administered. Consult with asthma specialist if step 4 or higher is required.

FEV₁: forced expiratory volume in one second; SABA: short-acting beta-agonist; ICS: inhaled corticosteroid (glucocorticoid); LABA: long-acting beta-agonist; MDI: metered dose inhaler; DPI: dry powder inhaler; LTRA: leukotriene receptor antagonist; IgE: immunoglobulin E; IL: interleukin; LAMA: long-acting muscarinic antagonist.

* Theophylline and cromolyn are not included in the table even though they were included in NAEPP-EPR 3 (2007) and theophylline is included in NAEPP (2020). These agents are rarely used now, due to availability of more effective options.

¶ Risk factors for exacerbations include: smoking, allergen exposure if sensitized, previous intubation or intensive care unit stay for asthma, low FEV₁ (especially <60% predicted), obesity, food allergy, chronic rhinosinusitis, and poor adherence/inhaler technique.

Δ Asthma biologics include anti-immunoglobulin E, anti-interleukin (IL)-5, anti-IL-5R, anti-IL-4R (anti-IL-4/IL-13), and anti-thymic stromal lymphopoietin (anti-TSLP). Refer to UpToDate graphic on our approach to selection of biologic agents for add-on therapy for severe asthma in adolescents and adults.

◊ The NAEPP 2020 Focused Updates included LAMA therapy in step 5 but not step 6; however, a trial of add-on LAMA therapy is reasonable, if not previously assessed.

References:

National Asthma Education and Prevention Program: Expert panel report III: Guidelines for the diagnosis and management of asthma. Bethesda, MD: National Heart, Lung, and Blood Institute, 2007. (NIH publication no. 08-4051). https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma.
2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. J Allergy Clin Immunol 2020;146:1217-70. https://www.nhlbi.nih.gov/health-topics/asthma-management-guidelines-2020-updates.
Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA). www.ginasthma.org.

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