Guideline approaches to stepping up asthma controller therapy in adolescents and adults

National Asthma Education and Prevention Program (NAEPP)^[1,2]		Global Initiative for Asthma (GINA)^[3]
Qualifying criteria	Therapy^*	Qualifying criteria	Therapy
Step 1		Step 1
All of the following at initiation of therapy or using SABA alone: Daytime symptoms ≤2 days/week Nocturnal awakenings ≤2/month Normal FEV₁ Exacerbations ≤1/year	SABA, as needed	All of the following at initiation of therapy or using SABA alone: Infrequent asthma symptoms (eg, <2 times/week) No risk factors for exacerbations^¶	Low-dose ICS-formoterol as needed (preferred)^Δ or Low-dose ICS-SABA or ICS plus SABA, concomitantly administered, as needed^Δ
Step 2		Step 2
Poor asthma symptom control,^* exacerbations requiring systemic glucocorticoids, or high risk of exacerbation^¶ on Step 1 therapy despite: Addressing modifiable environmental factors and comorbidities Good adherence and inhaler technique	Low-dose ICS daily and SABA as needed or Low-dose ICS-SABA or ICS plus SABA, concomitantly administered, as needed^Δ Alternative option(s) Daily LTRA and SABA as needed	Poor asthma symptom control,^* exacerbations requiring systemic glucocorticoids, or high risk of exacerbation^¶ on Step 1 therapy despite: Addressing modifiable environmental factors and comorbidities Good adherence and inhaler technique	Low-dose ICS-formoterol as needed (preferred)^Δ or Low-dose ICS daily and SABA as needed Other options Low-dose ICS-SABA or ICS plus SABA, concomitantly administered, as needed^Δ or (less preferred) LTRA daily and SABA as needed
Step 3		Step 3
Poor asthma symptom control,^* exacerbations requiring systemic glucocorticoids, or high risk of exacerbation^¶ on Step 2 therapy despite: Addressing modifiable environmental factors and comorbidities Good adherence and inhaler technique	Low-dose ICS-formoterol as maintenance and reliever therapy (preferred)^◊ 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 anti-leukotriene daily and SABA as needed	Poor asthma control,^* exacerbations requiring systemic glucocorticoids, or high risk of exacerbation^¶ on Step 2 therapy despite: Addressing modifiable environmental factors and comorbidities Good adherence and inhaler technique	Low-dose ICS-formoterol as maintenance and reliever therapy (preferred)^◊ or Low-dose ICS-LABA combination daily and SABA as needed Other options Medium-dose ICS daily and SABA or ICS-SABA as needed or Low-dose ICS plus LTRA daily and SABA or ICS-SABA^Δ as needed
Step 4		Step 4
Poor asthma symptom control,^* exacerbations requiring systemic glucocorticoids, or high risk of exacerbation^¶ on Step 3 therapy despite: Addressing modifiable environmental factors and comorbidities Good adherence and inhaler technique	Medium-dose ICS-formoterol as maintenance and reliever therapy (preferred)^◊ Alternative option(s) Medium-dose ICS-LABA combination daily or medium-dose ICS plus LAMA daily or medium-dose ICS plus anti-leukotriene daily and SABA as needed^§	Poor asthma symptom control,^* exacerbations requiring systemic glucocorticoids, or high risk of exacerbation^¶ on Step 3 therapy despite: Addressing modifiable environmental factors and comorbidities Good adherence and inhaler technique	Medium-dose ICS-formoterol as maintenance and reliever therapy (preferred)^◊ or Medium-dose ICS-LABA daily and SABA or ICS-SABA^Δ as needed Other options Possible add-on LAMA or switch to ICS-LAMA-LABA Possible add-on LTRA
Step 5		Step 5
Poor asthma control,^* exacerbations requiring systemic glucocorticoids, or high risk of exacerbation^¶ on Step 4 therapy despite: Addressing modifiable environmental factors and comorbidities Good adherence and inhaler technique	Medium- to high-dose ICS-LABA plus LAMA daily (or ICS-LAMA-LABA daily) and SABA as needed (preferred) or Medium- to high-dose ICS-LABA daily plus LTRA daily and SABA as needed^§ *and* Assess asthma phenotype and evaluate for possible addition of asthma biologics^¥	Poor asthma symptom control,^* exacerbations requiring systemic glucocorticoids, or high risk of exacerbation^¶ on Step 4 therapy despite: Addressing modifiable environmental factors and comorbidities Good adherence and inhaler technique	Medium-dose ICS-formoterol as maintenance and reliever therapy plus LAMA daily (preferred)^◊ or Medium-dose ICS-LABA daily plus LAMA daily (or ICS-LAMA-LABA daily) and SABA or ICS-SABA^Δ as needed *and* Assess asthma phenotype and evaluate for possible addition of asthma biologics^¥ Other options Possible add-on LTRA or azithromycin Possible high-dose ICS-LABA trial (3 to 6 months)

This table illustrates major guideline recommendations for ongoing asthma therapy. 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. Consultation with an asthma specialist is recommended if step 4 or higher is required. Therapeutic strategies for newly diagnosed patients or for patients using SABA therapy alone are covered separately. For additional information, please refer to UpToDate content on initial and ongoing treatment of asthma.

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

* Good asthma symptom control is generally defined as bothersome asthma symptoms or need for SABA inhaler less than twice a week, no nocturnal awakenings, and no activity limitations due to asthma. For patients on ICS-formoterol, ICS-SABA, or ICS plus SABA reliever therapy (aka, anti-inflammatory reliever therapy), reliever use more frequently (but less than daily) is reasonable as long as other symptoms are well controlled.

¶ Risk factors for exacerbations include: poor asthma symptom control, a history of asthma exacerbation on the current regimen, 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. Please refer to UpToDate asthma treatment content and separate graphic on risk factors for asthma exacerbation.

Δ When prescribed for use as-needed for acute asthma symptoms, ICS-formoterol, ICS-SABA, and concomitant ICS and SABA use are referred to as anti-inflammatory reliever therapy. Compared with SABA relievers, use of anti-inflammatory reliever therapy has demonstrated decreased exacerbation risk in patients with all degrees of asthma severity.

◊ ICS-formoterol prescribed for use as both maintenance therapy and for acute relief of symptoms is referred to as maintenance and reliever therapy (MART). MART has been shown to be more effective in terms of exacerbation reduction and symptom relief compared with ICS-formoterol and SABA alone as reliever therapy.

§ 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 due to availability of more effective options.

¥ Asthma biologics include anti-immunoglobulin E, anti-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.

References:

National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program: Expert panel report III: Guidelines for the diagnosis and management of asthma. Revised August 2007 (NIH publication no. 07-4051). Available at: https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma (Accessed November 3, 2023).
National Heart, Lung, and Blood Institute. 2020 focused updates to the asthma management guidelines: A report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. December 2020 (NIH publication no. 20-HL-8140). Available at: https://www.nhlbi.nih.gov/health-topics/asthma-management-guidelines-2020-updates (Accessed November 3, 2023).
Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention, 2023. Updated July 2023. Available at: https://ginasthma.org/2023-gina-main-report/ (Accessed November 8, 2023).

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Guideline approaches to stepping up asthma controller therapy in adolescents and adults