Efficacy

SYMBICORT helped patients breathe better within 15 minutes² and this control was sustained over the long-term^3,*

 

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

P values and 95% confidence intervals using 2-sided alternatives, unadjusted for multiplicity, are presented; however, these were considered descriptive in nature to aid in data interpretation, and this output from statistical analyses was not associated with a decision rule.

Study 1:

A 12-week, double-blind, placebo-controlled study comparing SYMBICORT 160/4.5 mcg, budesonide (BUD) 160 mcg, formoterol (FM) 4.5 mcg, the free combination of BUD 160 mcg plus FM 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. Most patients had moderate to severe asthma and were using moderate to high doses of inhaled corticosteroids (ICSs) prior to study entry.

Mean percent improvement within 15 minutes for the comparator arms on day of randomization was BUD, 2.4%; FM, 16.9%; BUD + FM, 16.3%; and placebo, 2.1%; and at end of treatment, it was BUD, 6.0%; FM, 8.5%; BUD + FM, 17.0%; and placebo,
-3.0%.

Study 728:

A 52-week, double-blind, single-dummy, parallel-group, multicenter study comparing the long-term safety of
SYMBICORT 160/4.5 mcg, 4 inhalations twice daily; SYMBICORT 160/4.5 mcg, 2 inhalations twice daily; and budesonide hydrofluoroalkane 160 mcg, 4 inhalations twice daily, in 708 patients (132 randomized to receive SYMBICORT 160/4.5 mcg, 2 inhalations twice daily) ≥12 years of age with moderate to severe persistent asthma. The primary objective of this study was to assess the long-term safety of SYMBICORT and budesonide. However, spirometry (predose and 2-hour postdose FEV₁) was conducted at each study visit to detect any untoward decrease in lung function over the 52-week treatment period. Additional coprimary objectives included asthma exacerbations, electrocardiograms and Holter monitoring, and morning peak expiratory flow (PEF).

 

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Each dose^† of SYMBICORT provided rapid improvement in lung function within 15 minutes^2,3,*

 

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

 

Study 1:

A 12-week, double-blind, placebo-controlled study comparing SYMBICORT 160/4.5 mcg, budesonide (BUD) 160 mcg, formoterol (FM) 4.5 mcg, the free combination of BUD 160 mcg plus FM 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. Most patients had moderate to severe asthma and were using moderate to high doses of inhaled corticosteroids (ICSs) prior to study entry.

Mean percent improvement within 15 minutes for the comparator arms on day of randomization was BUD, 2.4%; FM, 16.9%; BUD + FM, 16.3%; and placebo, 2.1%; and at end of treatment, it was BUD, 6.0%; FM, 8.5%; BUD + FM, 17.0%; and placebo,
-3.0%.

SYMBICORT should not be used more often or at higher doses than recommended. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma.

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Most patients felt SYMBICORT begin to work right away^4-6,‡

 

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

 

Study 1:

A 12-week, double-blind, placebo-controlled study comparing SYMBICORT 160/4.5 mcg, budesonide (BUD) 160 mcg, formoterol (FM) 4.5 mcg, the free combination of BUD 160 mcg plus FM 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. Most patients had moderate to severe asthma and were using moderate to high doses of inhaled corticosteroids (ICSs) prior to study entry.

A subset of patients ≥18 years of age (n=442) from the study were assessed on a weekly basis using the Onset of Effect Questionnaire, administered through an electronic diary to record patients' responses to 5 statements concerning onset of medication.

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*Onset of clinically significant bronchodilation (>15% improvement in forced expiratory volume in 1 second [FEV₁]) occurred within 15 minutes (median time). In pivotal US clinical studies, asthma control was defined as the coprimary efficacy end points of the 12-hour-average postdose FEV₁ at week 2 and predose FEV₁, averaged over 12 weeks.

^†Mean percent change from baseline FEV₁ was measured at day of randomization, week 2, and end of treatment.

^‡Sixty-nine percent of patients reported feeling SYMBICORT begin to work right away during the first week of treatment. Throughout the study, most patients reported feeling it begin to work right away.