SYMBICORT for your asthma patients ≥12 years of age uncontrolled on an ICS or whose disease severity clearly warrants an ICS/LABA

The efficacy of SYMBICORT

In a 12-week efficacy and safety study of patients with moderate to severe asthma:

SYMBICORT 160/4.5 significantly improved predose FEV1 (P<.05 vs budesonide, formoterol, and placebo) averaged over the course of the study, and also improved 12-hour average postdose FEV1 (P<.001 vs budesonide, formoterol, and placebo at week 2), coprimary endpoints1; 2-hour postdose FEV1 over 12 weeks was a secondary endpoint.2

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

 

SYMBICORT for your asthma patients ≥12 years of age uncontrolled on an ICS or whose disease severity clearly warrants an ICS/LABA

The efficacy of SYMBICORT

In a 12-week efficacy and safety study of patients with moderate to severe asthma:

SYMBICORT 160/4.5 significantly improved predose FEV1 (P<.05 vs budesonide, formoterol, and placebo) averaged over the course of the study, and also improved 12-hour average postdose FEV1 (P<.001 vs budesonide, formoterol, and placebo at week 2), coprimary endpoints1; 2-hour postdose FEV1 over 12 weeks was a secondary endpoint.2

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

Click on the links below to view clinical data about the efficacy and safety of SYMBICORT in the treatment of asthma:

Study Designs

The efficacy and safety of SYMBICORT was evaluated in 2 pivotal studies2,9

Study 1

A 12-week, double-blind, placebo-controlled study comparing SYMBICORT 160/4.5 mcg, budesonide 160 mcg, formoterol 4.5 mcg, the free combination of budesonide 160 mcg plus formoterol 4.5 mcg in separate inhalers, and placebo, each administered as 2 inhalations twice daily. A total of 596 patients (124 randomized to receive SYMBICORT) ≥12 years of age were evaluated. The study included a 2-week run-in period with budesonide 80 mcg, 2 inhalations twice daily. Most patients had moderate to severe asthma and were using moderate to high doses of inhaled corticosteroids (ICSs) prior to study entry. This study was designed to assess 2 primary endpoints. The first was predose FEV1 averaged over 12 weeks, and the second was 12-hour average postdose FEV1 at week 2. Secondary efficacy variables included daytime and nighttime asthma symptom scores and daily rescue medication use (both recorded by patients in the electronic diary).

Study 2

A 12-week, randomized, multicenter, double-blind, double-dummy, placebo-controlled study comparing SYMBICORT 80/4.5 mcg, budesonide 80 mcg, formoterol 4.5 mcg, each administered as 2 inhalations twice daily. A total of 480 patients (123 randomized to receive SYMBICORT) ≥12 years of age were evaluated. The study included a 2-week run-in period with placebo and rescue albuterol therapy. Most patients had mild to moderate persistent asthma and were using low to moderate doses of ICS either alone or as part of combination therapy prior to study entry. This study was designed to assess 2 primary endpoints. The first was predose FEV1 averaged over 12 weeks, and the second was 12-hour average postdose FEV1 at Week 2. Secondary efficacy variables included daytime and nighttime asthma symptom scores and daily rescue medication use (both recorded by patients in the electronic diary).

*Subject to eligibility rules; restrictions apply.