SYMBICORT 160/4.5 for the maintenance treatment of COPD

SYMBICORT safety profile

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

SYMBICORT 160/4.5 for the maintenance treatment of COPD

SYMBICORT safety profile

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

Adverse reactions in COPD clinical studies†‡1

Adverse reactions occurring at an incidence of ≥3% and more commonly than placebo in the SYMBICORT group1

TREATMENT SYMBICORT BUDESONIDE FORMOTEROL PLACEBO
Adverse reaction (%)

160/4.5 mcg (n=771)

160 mcg (n=275)§

4.5 mcg (n=779)

(n=781)

Nasopharyngitis 7.3 3.3 5.8 4.9
Oral candidiasis 6.0 4.4 1.2 1.8
Bronchitis 5.4 4.7 4.5 3.5
Sinusitis 3.5 1.5 3.1 1.8
Viral upper respiratory tract infection 3.5 1.8 3.6 2.7
Average duration of exposure (days) 255.2 157.1 240.3 223.7

Incidence of pneumonia was not greater in the SYMBICORT 160/4.5 group compared with placebo (2.3% vs 3.3%, respectively) in the pooled safety data from the SUN and SHINE studies2

Combined data from 2 pivotal clinical studies of patients with COPD taking SYMBICORT.

All treatments were administered as 2 inhalations twice daily.

§Because the SUN Study did not include a budesonide arm, there are fewer patients in this treatment group.

NASOPHARYNGITIS %
SYMBICORT 160/4.5 mcg (n=771) 7.3
Budesonide 160 mcg (n=275)§ 3.3
Formoterol 4.5 mcg (n=779) 5.8
Placebo (n=781) 4.9
ORAL CANDIDIASIS %
SYMBICORT 160/4.5 mcg (n=771) 6.0
Budesonide 160 mcg (n=275)§ 4.4
Formoterol 4.5 mcg (n=779) 1.2
Placebo (n=781) 1.8
BRONCHITIS %
SYMBICORT 160/4.5 mcg (n=771) 5.4
Budesonide 160 mcg (n=275)§ 4.7
Formoterol 4.5 mcg (n=779) 4.5
Placebo (n=781) 3.5
SINUSITIS %
SYMBICORT 160/4.5 mcg (n=771) 3.5
Budesonide 160 mcg (n=275)§ 1.5
Formoterol 4.5 mcg (n=779) 3.1
Placebo (n=781) 1.8
VIRAL UPPER RESPIRATORY TRACT INFECTION %
SYMBICORT 160/4.5 mcg (n=771) 3.5
Budesonide 160 mcg (n=275)§ 1.8
Formoterol 4.5 mcg (n=779) 3.6
Placebo (n=781) 2.7
AVERAGE DURATION OF EXPOSURE (DAYS) %
SYMBICORT 160/4.5 mcg (n=771) 255.2
Budesonide 160 mcg (n=275)§ 157.1
Formoterol 4.5 mcg (n=779) 240.3
Placebo (n=781) 223.7

Incidence of pneumonia was not greater in the SYMBICORT 160/4.5 group compared with placebo (2.3% vs 3.3%, respectively) in the pooled safety data from the SUN and SHINE studies2

Combined data from 2 pivotal clinical studies of patients with COPD taking SYMBICORT.

All treatments were administered as 2 inhalations twice daily.

§Because the SUN Study did not include a budesonide arm, there are fewer patients in this treatment group.