Asthma (controller/maintenance): Treatment of asthma in patients ≥6 years of age.
Chronic obstructive pulmonary disease: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema; to reduce COPD exacerbations.
Off Label Uses
Asthma (reliever for acute exacerbations)
Data from 2 randomized, double-blind, parallel group trials support the use of budesonide/formoterol (single combination inhaler) as quick relief on an as-needed basis for acute asthma exacerbations in outpatients with mild to mild to moderate asthma, and reduced overall corticosteroid exposure [Bateman 2018], [O’Byrne 2018]. In addition, data from 2 studies showed a reduction in the rate of severe asthma exacerbations when compared to use of an as-needed short-acting beta agonist [Beasley 2019], [O’Byrne 2018]. Data from 2 randomized, parallel group trials support the use of budesonide/formoterol single combination inhaler for use as maintenance and reliever therapy (SMART) and was shown to reduce the risk of severe asthma exacerbations and oral systemic corticoid exposure [Patel 2013], [Rabe 2006]. Data from a meta-analysis (15 clinical trials) also support the use of budesonide/formoterol as single maintenance and reliever therapy compared to standard therapy in patients with persistent asthma and was associated with a lower risk of asthma exacerbations [Sobieraj 2018].
Based on the Global Initiative for Asthma: Global Strategy for Asthma Management and Prevention guidelines, use of combination low dose budesonide/formoterol single inhaler in patients with asthma exacerbations may be used as both maintenance and reliever treatment and was shown to reduce exacerbations, including exacerbations requiring oral corticosteroids and hospitalizations [GINA 2020].
