Efficacy

Forced expiratory volume and asthma control.

In combination maintenance therapy for asthma . . .
SYMBICORT exhibited rapid improvement in lung function within 15 minutes^3,7*; in addition, most patients felt it begin to work right away^8,9†

SYMBICORT delivered improved
asthma control^‡ as early as day 1 and over the long term3,5,6

Asthma control^‡ as early as day 1
Improvement in FEV1 in a 12-week study
Reduction in albuterol use over 12 weeks
Improvement in FEV1 over 52 weeks

SYMBICORT exhibited rapid improvement in lung function within 15 minutes^3,7*; in addition, most patients felt it begin to work right away^8,9†

Improvement in FEV1 over 12 hours

From day 1^§, SYMBICORT helps reassure patients that their medication is working

SYMBICORT 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 asthma symptoms

Reduced the need
for rescue medication

Improved AM and PM PEF

Study 1: a 12-week efficacy and safety study

Improvement in FEV₁ in a 12 week study3

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%.

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.

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.

Exhibited rapid improvement in lung function within 15 minutes^3,7

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

*Onset of significant bronchodilation (>15% improvement in forced expiratory volume in 1 second [FEV₁]) occurred within 15 minutes (median time).

†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. These data are based on results from a subset of patients >18 years of age (n=442) participating in a 12-week efficacy and safety study for SYMBICORT. Patients were assessed on a weekly basis using the Onset of Effect Questionnaire, administered through an electronic diary to record their responses to 5 statements concerning onset of medication.

‡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. In addition, measures of asthma control included improvement in peak expiratory flow (PEF) and reduction in asthma symptoms and albuterol rescue use.

§From day 1, maximum improvement in FEV₁ occurred within 3 hours and clinically significant improvement was maintained over 12 hours. SYMBICORT improved predose FEV₁ and AM and PM PEF and reduced albuterol use and asthma symptoms.

||Pressurized metered-dose inhaler.

Indications and Important Safety Information, including boxed WARNING

SYMBICORT is indicated for the long-term maintenance treatment of asthma in patients 12 years and older
SYMBICORT is NOT indicated for the relief of acute bronchospasm and should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma
SYMBICORT is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled short-acting beta₂-agonists
WARNING: Long-acting beta₂-adrenergic agonists may increase the risk of asthma-related death. SYMBICORT should only be used for patients with asthma not adequately controlled on other asthma-controller medications (eg, low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled US study that compared the safety of another long-acting beta₂-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta₂-adrenergic agonist), one of the active ingredients in SYMBICORT (see WARNINGS in full Prescribing Information)
SYMBICORT does NOT replace fast-acting inhalers and should not be used to treat acute symptoms of asthma
Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids
Patients who are receiving SYMBICORT should not use additional formoterol or other long-acting inhaled beta₂-agonists for any reason
SYMBICORT should be used with caution in patients with cardiovascular disorders. Some patients may experience an increase in blood pressure or heart rate
SYMBICORT, like all medications containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), untreated hypokalemia, thyrotoxicosis, convulsive disorders, and in patients who are unusually responsive to sympathomimetic amines
Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may affect normal bone metabolism resulting in a loss of bone mineral density. In patients with major risk factors for decreased bone mineral content, such as tobacco use, advanced age, sedentary lifestyle, poor nutrition, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants and corticosteroids), orally inhaled corticosteroids may pose an additional risk
Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT
Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT. In three placebo-controlled US clinical studies, the incidence of lower respiratory tract infections, including pneumonia, was low, with no consistent evidence of increased risk with SYMBICORT, compared to placebo
SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents
The most common adverse events ≥5% reported in clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort

Please see full Prescribing Information, including boxed WARNING.

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This product information is intended for US health care professionals only.

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