Symbicort now available as metered-dose inhaler for COPD

Symbicort (formoterol/budesonide) is now available as a pressurised metered-dose inhaler (pMDI) for patients with moderate to severe COPD.

Symbicort contains the long-acting beta2 agonist formoterol and the corticosteroid budesonide, which show additive effects in reducing COPD exacerbations. | SCIENCE PHOTO LIBRARY
Symbicort contains the long-acting beta2 agonist formoterol and the corticosteroid budesonide, which show additive effects in reducing COPD exacerbations. | SCIENCE PHOTO LIBRARY

Further information
View Symbicort drug record
Summary of Product Characteristics
Manufacturer: AstraZeneca
MIMS Respiratory Clinic

Symbicort pMDI provides a metered dose of 200 microgram budesonide and 6 microgram formoterol fumarate dihydrate (corresponding to delivered doses of 160 microgram and 4.5 microgram, respectively). It is indicated in adults with COPD who have a post-bronchodilator FEV1 less than 70% predicted normal and a history of exacerbations despite regular bronchodilator therapy. Two puffs are taken twice daily.

Symbicort was previously only available in the dry powder Turbohaler device.

Pre- and post-dose FEV1

A 6-month randomised, double-blind trial evaluated the effect of budesonide/formoterol pMDI on pre-dose and 1-hour post-dose FEV1 in 1704 patients with moderate to very severe COPD. Participants underwent a 2-week run-in phase and were then treated with budesonide/formoterol pMDI 160/4.5 microgram; budesonide/formoterol pMDI 80/4.5 microgram; budesonide pMDI 160 microgram plus formoterol dry powder inhaler (DPI) 4.5 microgram; budesonide pMDI 160 microgram; formoterol DPI 4.5 microgram; or placebo. All medications were given twice daily.

Improvements in pre-dose FEV1 were significantly greater in patients treated with budesonide/formoterol 160/4.5 microgram twice daily than in those who received formoterol 4.5 microgram alone (p=0.026). Significantly greater improvements were also demonstrated in 1-hour post-dose FEV1 for budesonide/formoterol 160/4.5 microgram versus budesonide 160 microgram alone (p<0.001).

Dyspnoea (assessed with breathlessness diaries) and health-related quality of life scores (based on the St George's Respiratory Questionnaire total score) were significantly improved with budesonide/formoterol 160/4.5 microgram twice daily compared with either agent alone or placebo (p≤0.044 for all).

Long-term use

A 12-month double-blind study (n=1964) randomised COPD patients to receive twice-daily doses of budesonide/formoterol pMDI 160/4.5 microgram, budesonide/formoterol pMDI 80/4.5 microgram, formoterol DPI 4.5 microgram, or placebo.

Patients taking budesonide/formoterol 160/4.5 microgram twice daily experienced greater improvements in pre-dose FEV1 than those taking formoterol alone (p=0.008), and greater improvements in 1-hour post-dose FEV1 than those in the placebo group (p<0.001).

Exacerbation reduction

Another 12-month study randomised 1219 patients to receive budesonide/formoterol pMDI 160/4.5 microgram, budesonide/formoterol pMDI 80/4.5 microgram or formoterol DPI 4.5 microgram, all taken twice daily after an initial 2-week run-in period. Exacerbations, defined as worsening of COPD requiring oral corticosteroids and/or hospitalisation, were analysed.

Compared with the formoterol group, patients in the budesonide/formoterol 160/4.5 microgram twice-daily group experienced a 34.6% reduction in exacerbation rate (p≤0.002). Budesonide/formoterol 160/4.5 microgram prolonged the time to first exacerbation compared with formoterol, corresponding to a 21.2% reduction in hazard ratio (0.788, 95% Cl 0.6390.972; p=0.026).

When exacerbations were defined as worsening of COPD requiring oral corticosteroids, hospitalisation or antibiotic treatment, post-hoc analysis showed that rates were reduced by 25.9% with formoterol/budesonide 160/4.5 microgram twice daily versus formoterol (p≤0.023).

Studies showed that budesonide/formoterol was relatively well tolerated when administered via pMDI. Side-effects similar to those experienced after use of the individual components may occur. The most common effects are tremor and palpitations, which are usually mild and disappear within a few days.

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