Budesonide-formoterol (brand name, SymbicortAstraZeneca) is a maintenance treatment used to prevent bronchospasm (airway narrowing) caused by COPD. It is a combination of an inhaled corticosteroid (budesonide) that reduces inflammation, and a long-acting bronchodilator (formoterol) that relaxes airway muscles.

How does budesonide-formoterol for COPD work?

Budesonide is a corticosteroid that works by reducing swelling in the airways. Formoterol is a long-acting, selective beta2-agonist (LABA) bronchodilator with a rapid onset of action that works by relaxing and opening the airways to the lungs, making breathing easier. As a maintenance treatment, this drug is used even when COPD symptoms are not evidence, and it is not to be used as a “rescue” bronchodilator for a sudden worsening of symptoms during a flare.

The anti-inflammatory activity of budesonide is what works upon disease processes in COPD, whose inflammatory agents include multiple cell types (mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (histamine, eicosanoids, leukotrienes, and cytokines). Corticosteroids like budesonide have a wide range of inhibitory activities against these cells and mediators.

As a selective LABA, formoterol acts to stimulate an enzyme, called adenyl cyclase, in the smooth muscle cells of the lungs. This enzyme helps convert adenosine triphosphate (ATP) to cyclic adenosine monophosphate (cAMP). When the levels of cAMP increase, these muscle cells relax, inhibiting the release of mediators of immediate hypersensitivity from cells, especially from mast cells.

Beta2-receptors are predominant in the muscle cells of the lungs, but they are also present in the heart, which means LABAs like formoterol may have cardiac effects, such as an irregular heartbeat.

Studies of budesonide-formoterol studies

The efficacy of budesonide-formoterol (Symbicort) in treating airflow obstruction in people with COPD was evaluated in two Phase 3 studies: one that assessed efficacy over six months (NCT00206154) and the other over 12 months (NCT00206167). More than 3,600 people were included, all active or former smokers who had been diagnosed with COPD at least two years ago and had an FEV1 (a measure of lung health) of less than or equal to 50% predicted.

Data showed that Symbicort-treated patients (160/4.5 mcd — budesonide 160 mcg + formoterol 4.5 mcg — two inhalations twice daily) had significantly greater improvements in FEV1 from study start (baseline FEV1) compared to those treated with formoterol (4.5 mcg) or placebo in both studies. Significant improvement over comparator treatments (formoterol and placebo) was not seen in COPD patients given a lower dose group of Symbicort (80/4.5, two inhalations twice daily).

Both studies also supported the efficacy of the combination at a 160/ 4.5 mcg dose in for reducing the need for rescue medication, and in secondary measures of morning and evening peak expiratory flow (self-reported by patients and seen in clinical examinations).

Indications and side effects

The combination of budesonide-formoterol in Symbicort is inhaled by mouth using an inhaler, normally as two puffs each morning and evening.  Patients are advised to always rinse the mouth with water after using the inhaler device to help prevent thrush (a fungal infection of the mouth or throat).

The most common side effects of this medication include throat irritation after inhaler use, stomach discomfort, vomiting, cold and flu symptoms, back pain and headache. White patches in the mouth or throat could be a sign of thrush, and a doctor should be notified should they appear.

There is no generic available.

 

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