Budesonide and formoterol fumarate dihydrate

(Symbicort®)

Symbicort®

Drug updated on 11/1/2024

Dosage FormInhalation (oral; budesonide [80 or 160 mcg] and formoterol [4.5 mcg])
Drug ClassCorticosteroids 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.

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Summary
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  • 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 TitleYearSource
Symbicort (budesonide and formoterol fumarate dihydrate) Prescribing Information.2019AstraZeneca, Wilmington, DE

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Global strategy for asthma management and prevention, 2022.2022Global Initiative for Asthma
Asthma guideline updates.2022ACSAP: Pulmonary Care
A Practical Guide to Implementing SMART in Asthma Management2022The Journal of Allergy and Clinical Immunology. In Practice