Drug updated on 11/1/2024
Dosage Form | Inhalation (oral; budesonide [80 or 160 mcg] and formoterol [4.5 mcg]) |
Drug Class | Corticosteroids and beta-2 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
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- In moderate-to-severe COPD (Chronic obstructive pulmonary disease) patients, budesonide/formoterol (BF) significantly reduced exacerbations (RR (relative risk) 0.91 [95% CI (confidence interval) 0.83-1.00]; p = 0.040), hospitalizations (RR 0.77 [95% CI 0.67-0.88]; p < 0.001), and pneumonia frequency (RR 0.77 [95% CI 0.64-0.92]; p = 0.05) compared to fluticasone/salmeterol (FS), with no significant effect on ED visits, hospitalization duration, or exacerbation frequency.
- In asthma patients with poorly controlled symptoms, the SMART regimen with budesonide/formoterol delayed time to the first severe exacerbation and reduced risk compared to continued GINA Step 3-5 treatment with ICS-LABA plus SABA reliever (HR 0.71 [95% CI 0.52-0.97]; HR (hazard ratio) 0.70 [95% CI 0.58-0.85]).
- For mild asthma, a fixed-dose budesonide/formoterol combination reduced exacerbations requiring systemic steroids (OR 0.45 [95% CI 0.34-0.60]) and hospital admissions/ED visits (OR 0.35 [95% CI 0.20-0.60]), showing better asthma control over FABA alone, with minimal difference compared to regular ICS in exacerbation reduction or control.
- COPD Treatment: BF reduced pneumonia frequency compared to FS (RR 0.77 [95% CI 0.64-0.92]).
- Mild Asthma: FABA/ICS may reduce adverse events (OR 0.82 [95% CI 0.71-0.95]) and total systemic steroid dose; no significant mortality differences observed.
- The population types include moderate-to-severe COPD patients, adults and adolescents with poorly controlled asthma, adolescents and adults with mild asthma, adults, adolescents, and children with chronic asthma, pediatric and adult patients aged 6 and above for asthma, and a general population of asthma and COPD patients in real-world studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Symbicort (budesonide and formoterol fumarate dihydrate) Prescribing Information. | 2019 | AstraZeneca, Wilmington, DE |
Systematic Reviews / Meta-Analyses
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 |
A Practical Guide to Implementing SMART in Asthma Management | 2022 | The Journal of Allergy and Clinical Immunology. In Practice |