SYMBICORT 160/4.5 for the maintenance treatment of COPD

Patient profile

SYMBICORT 160/4.5 for the maintenance treatment of COPD

Patient profile

Meet Barbara Ann, a COPD patient

Here is an example of a patient, representative of a patient studied in the SUN Study for SYMBICORT:

Barbara Ann—55-year-old teacher

Frustrated with how COPD seems to be taking control of her day, starting in the morning.

History

  • Diagnosed with moderate COPD
    • Smoker (40 pack-year history; continues to smoke)
    • Prebronchodilator FEV1=50% predicted normal
  • Diabetic
  • Previously experienced an exacerbation

Current visit

  • Uses SABA >2 times/day
  • Presents with mucus-producing cough
  • Reports breathlessness
    • Often breathless from walking a few minutes at a normal pace
  • Says her symptoms are problematic even in the morning
    • Reports they often can interfere with her morning routine
  • Hypothetical patient case.
  • Short-acting beta2-adrenergic agonist.

SUN Patient Characteristics

SUN Patient Characteristics1,2

  • Diagnosis of moderate to very severe COPD1
    • 18% moderate
    • 82% severe/very severe
  • Symptomatic COPD for >2 years1
  • Using a short-acting inhaled bronchodilator for rescue1
  • Baseline lung function: FEV1 ~1L1
  • Median smoking history of 40 pack-years1
  • Comorbidities including:
    • Hypertension: 42%1
    • Abnormal EKGs: 31%2
    • Lipid abnormalities: 22%1
    • Cardiac disease: 18%1
    • Diabetes: 11%1
  • Prebronchodilator FEV1 of ≤50% of predicted normal and FEV1/FVC§ of <70%1
  • ≥40 years of age1
  • 60% had severe COPD; 22% had very severe COPD.
  • Forced expiratory volume in 1 second.
  • §Forced vital capacity.

Barbara Ann’s Profile

SHINE and SUN Study Designs

The efficacy and safety of SYMBICORT was evaluated in 2 pivotal studies

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.