Drug updated on 9/4/2024
| Dosage Form | Inhalation (oral; budesonide [80 or 160 mcg] and formoterol [4.5 mcg]) |
| Drug Class | Corticosteroids and long-acting beta2-adrenergic agonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for treatment of asthma in patients 6 years of age and older.
- Indicated for maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
Latest News
Summary
- Symbicort (budesonide and formoterol fumarate dihydrate) is indicated for the treatment of asthma in patients 6 years of age and older, and for the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- SMART regimen (single inhaler combination of ICS and formoterol) showed a 29% and 30% reduced risk of severe asthma exacerbations compared to maintenance ICS-LABA plus SABA in patients transitioning from GINA step 3 or 4 (HR 0.71; 95% CI, 0.52-0.97 and HR 0.70; 95% CI, 0.58-0.85).
- FABA/ICS as required reduced exacerbations requiring systemic steroids (OR 0.45; 95% CI 0.34 to 0.60) and possibly reduced asthma-related hospital admissions or emergency department visits (OR 0.35; 95% CI 0.20 to 0.60) compared to FABA alone.
- BFC (budesonide/formoterol combination) was more effective than FSC (fluticasone/salmeterol combination) in reducing total asthma exacerbations and was associated with a higher likelihood of meeting treatment escalation recommendations.
- Adverse Events: FABA/ICS as required likely reduces the odds of adverse events compared to FABA alone (OR 0.82; 95% CI 0.71 to 0.95). FB pMDI is considered safe for long-term use in patients aged 6 years and older, with no specific adverse effects reported.
- Systemic Steroid Dose: FABA/ICS as required may reduce the total systemic steroid dose compared to FABA alone (MD -9.90, 95% CI -19.38 to -0.42).
- The reviewed studies included adults, adolescents, and some children aged 12+, but did not provide stratified outcomes by age group or smoking status. Specific evidence highlighted the benefit of the SMART regimen in adults and adolescents with poorly controlled asthma at GINA steps 3 or 4 and the effectiveness of FABA/ICS as required in adults and adolescents with mild asthma.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Symbicort (budesonide and formoterol fumarate dihydrate) Prescribing Information. | 2019 | AstraZeneca Dunkerque Production, Dunkerque, France |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Evaluation of budesonide-formoterol for maintenance and reliever therapy among patients with poorly controlled asthma: A systematic review and meta-analysis. | 2022 | JAMA Network Open |
| Combination fixed-dose beta agonist and steroid inhaler as required for adults or children with mild asthma. | 2021 | The Cochrane Database of Systematic Reviews |
| Budesonide/formoterol therapy: Effective and appropriate use in asthma and chronic obstructive pulmonary disease. | 2020 | Journal of Comparative Effectiveness Research. |
| Comparing the efficacy and safety of formoterol/budesonide pMDI versus its mono-components and other LABA/ICS in patients with asthma. | 2020 | Respiratory Medicine |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Global strategy for asthma management and prevention, 2022. | 2022 | Global Initiative for Asthma |
| Asthma guideline updates. | 2022 | ACSAP: Pulmonary Care |
| Asthma management guidelines: Focused updates for 2020. | 2020 | American Family Physician |