Drug updated on 4/17/2024
| 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.
Summary
- Budesonide and formoterol fumarate dihydrate (Symbicort) is approved for treating asthma in patients 6 years and older, and for the maintenance treatment of airflow obstruction and reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD), including those with chronic bronchitis or emphysema.
- Four studies provided insights into the clinical efficacy, safety, and application considerations of Symbicort compared to other treatments for asthma and COPD.
- The SMART regimen involving Symbicort was shown to reduce the risk of severe asthma exacerbations by 29% - 30%, offering improved management control over traditional therapy, especially among adults and adolescents with poorly controlled symptoms.
- In mild cases of asthma, using Symbicort as a single combined inhaler on an 'as needed' basis not only reduces exacerbations requiring systemic steroids but also minimizes exposure to these steroids. This method marks progress in treating mild asthma by lowering both the rates of exacerbation and the required doses of systemic steroids.
- Studies comparing the effectiveness showed that users experienced fewer episodes with the budesonide/formoterol combination than with fluticasone/salmeterol combinations in managing asthma. For COPD management, budesonide/formoterol showed better results in reducing exacerbation rates compared to other treatments such as FSC or tiotropium.
- The evidence endorses its use across various population subsets, including adults, adolescents, and children above six years old, ranging from poorly controlled cases to milder ones. It underscores the importance of tailoring treatment to individual patient needs and the potential advantages of newer therapeutic strategies like SMART over traditional approaches.
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 |