Delivered improved asthma control* as early as Day 1 and over the long term3
As early as Day 1...3
As early as Day 1...3
Reduced the need
for rescue medication
Study 1: a 12-week efficacy and safety study
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Improvement in FEV1 in a 12 week study3
‡Pressurized metered-dose inhaler
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Reduction in albuterol use over 12 weeks (%)5
Study 2: description
A 12-week, double-blind, placebo-controlled study comparing SYMBICORT 80/4.5
mcg, budesonide 80 mcg, formoterol 4.5 mcg, and placebo, each administered as 2
inhalations twice daily. Most patients had mild to moderate asthma and were
using low to moderate doses of inhaled corticosteroids prior to study entry.
Mean number of albuterol inhalations per day at baseline for the groups
receiving SYMBICORT and budesonide was 2.75 and 2.99, respectively.
SYMBICORT does NOT replace fast-acting inhalers and should not be used to treat
acute symptoms of asthma
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In another study, improved lung function over 52 weeks6
-
In a 52-week safety study, SYMBICORT improved predose FEV1
versus twice the recommended dosage of budesonide
Study 728: description
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 PEF.
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Delivered improved lung function within 15 minutes†
of the first dose and at subsequent doses2-4
Rapid improvement in FEV1
from the first to the last dose3,4
-
SYMBICORT delivered improved lung function within 15 minutes†
of the first dose and at subsequent doses
-
Within 15 minutes of the first dose of SYMBICORT, patients experienced a 15.8%
mean improvement in FEV1
-
Within 15 minutes of the last dose of SYMBICORT, patients experienced an 8.7%
incremental improvement in FEV1
in addition to the 9.4% maintenance effect—for a total mean improvement of
18.1% from baseline
Study 1: description
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. Percent change for comparator arms
within 15 minutes on day of randomization: BUD, 2.4%; FM, 16.9%; BUD + FM,
16.3%; placebo, 2.1%; and end of treatment: BUD, 6.0%; FM, 8.5%; BUD + FM,
17.0%; placebo, -3.0%.
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