SYMBICORT 160/4.5 for the maintenance treatment of COPD

The efficacy of SYMBICORT

BETTER BREATHING—FAST

Majority of FEV1 improvement at 5 minutes each time in a subset of SUN Study patients taking SYMBICORT 160/4.5 (n=121)1,2,5

CONTROL THEY NEED

Significant lung function improvement with continuous control, as demonstrated over 12 months in the SUN Study (n=494)1,2

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms

The most common adverse reactions ≥3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection

In a serial spirometry subset of patients taking SYMBICORT 160/4.5 (n=121) in the SUN Study, 67% of 1-hour postdose FEV1 improvement occurred at 5 minutes on day of randomization, 83% at month 6, and 84% at end of treatment.1,2,5

SYMBICORT 160/4.5 for the maintenance treatment of COPD

The efficacy of SYMBICORT

BETTER BREATHING—FAST

Majority of FEV1 improvement at 5 minutes each time in a subset of SUN Study patients taking SYMBICORT 160/4.5 (n=121)1,2,5

CONTROL THEY NEED

Significant lung function improvement with continuous control, as demonstrated over 12 months in the SUN Study (n=494)1,2

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms

The most common adverse reactions ≥3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection

In a serial spirometry subset of patients taking SYMBICORT 160/4.5 (n=121) in the SUN Study, 67% of 1-hour postdose FEV1 improvement occurred at 5 minutes on day of randomization, 83% at month 6, and 84% at end of treatment.1,2,5

Click on the links below to view clinical data about the efficacy and safety of SYMBICORT 160/4.5 in the treatment of COPD:

SHINE: A 6-Month Efficacy and Safety Study

A 6-month, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multicenter study of 1704 patients with COPD compared SYMBICORT pressurized metered-dose inhaler (pMDI) 160/4.5 mcg (n=277), SYMBICORT pMDI 80/4.5 mcg (n=281), budesonide 160 mcg (n=275), formoterol 4.5 mcg (n=284), the free combination of budesonide 160 mcg plus formoterol 4.5 mcg (n=287), and placebo (n=300), each administered as 2 inhalations twice daily. Subjects were current or ex-smokers with a smoking history of ≥10 pack-years, aged ≥40 years with a clinical diagnosis of COPD and symptoms for >2 years.

The study included a 2-week run-in period followed by a 6-month treatment period. This study was designed to assess change from baseline to the average over the randomized treatment period in predose FEV1 and in 1-hour postdose FEV1. The prespecified primary comparison for predose FEV1 was vs formoterol and for 1-hour postdose was vs budesonide.

SUN: A 12-Month Efficacy and Safety Study

A 12-month, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multicenter study of 1964 patients with COPD compared SYMBICORT pMDI 160/4.5 mcg (n=494), SYMBICORT pMDI 80/4.5 mcg (n=494), formoterol 4.5 mcg (n=495), and placebo (n=481), each administered as 2 inhalations twice daily. Subjects were current or ex-smokers with a smoking history of ≥10 pack-years, aged ≥40 years with a clinical diagnosis of COPD and symptoms for >2 years.

The study included a 2-week run-in period followed by a 12-month treatment period. This study was designed to assess change from baseline to the average over the randomized treatment period in predose FEV1 and in 1-hour postdose FEV1. The prespecified primary comparisons for predose FEV1 were vs placebo and formoterol and the primary comparison for 1-hour postdose was vs placebo.

*Subject to eligibility rules; restrictions apply.