Efficacy
For your patients with COPD
SYMBICORT 160/4.5 provided significant and sustained* improvement in lung function, with a majority of improvement occurring at 5 minutes2,3,†
SYMBICORT 160/4.5 reduced COPD symptom scores
- In a study, SYMBICORT reduced COPD symptom scores by 35% vs formoterol alone4
- SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
- The most common adverse events ≥3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection
*Sustained improvement in lung function was demonstrated in a 12-month efficacy and safety study.
†In a serial spirometry subset, in patients taking SYMBICORT 160/4.5 (n=121), 66.98% of 1-hour postdose FEV1 improvement occurred at 5 minutes on day of randomization, 82.84% at month 6, and 84.05% at end of treatment.
Efficacy Data Chart
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Click on the chart on the right to see clinical data from the SUN Study, a
12-month efficacy and safety study of SYMBICORT for the treatment of COPD.
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Study Design
SUN Study: 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 pressurized metered-dose inhaler (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 was vs placebo and formoterol and for 1-hour postdose was vs placebo.
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.
SYMBICORT 160/4.5 reduced COPD symptom scores
aThe Breathlessness, Cough, and Sputum Scale (BCSS) was a secondary end point measured in diary cards every day before the evening dose. Patients were asked to evaluate each symptom/item on a Likert-type scale ranging from 0 to 4, with higher scores indicating a more severe manifestation of the symptom. A total symptom score is expressed as the sum of 3 item scores, with a range of 0 to 12.
bBaseline is defined as the mean of all values obtained in the last 10 days of the run-in period. Mean BCSS baseline values are 5.35 for SYMBICORT 160/4.5 mcg, 5.39 for formoterol 4.5 mcg, and 5.34 for placebo.
cAdministered as 2 inhalations twice daily.
Mechanisms Underlying COPD
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Take a closer look at the lungs of patients with COPD and the role SYMBICORT 160/4.5 plays in the treatment of the disease.
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Important Safety Information, including Boxed warning
- WARNING: Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. A placebo-controlled study with another LABA (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients
- When treating patients with asthma, prescribe SYMBICORT only for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids
SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.
It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. 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 LABA for any reason.
Due to possible immunosuppression, potential worsening of infections could occur; a more serious course of chickenpox or measles can occur in susceptible patients.
Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT, like all products containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, and cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients. As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT. Use with caution in patients with diabetes mellitus.
Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may result in a reduction in growth velocity and/or a loss of bone mineral density.
Glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT.
In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions.
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. Caution should also be exercised in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors.
Additional Information Specific to Asthma
The most common adverse reactions ≥3% reported in clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.
Additional Information Specific to COPD
- For patients with COPD, the approved dosage of SYMBICORT is 160/4.5 mcg, 2 inhalations twice daily
- The most common adverse events ≥3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection
- Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids
- In 2 placebo-controlled SYMBICORT COPD clinical studies, pneumonia did not occur with greater incidence in the SYMBICORT 160/4.5 group, compared with placebo, while the incidence of lung infections other than pneumonia (eg, bronchitis) was higher for SYMBICORT than placebo
Indications
SYMBICORT is indicated for the treatment of asthma in patients 12 years and older (also see Boxed WARNING).
SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
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 or COPD.
Prescribing Information
, including Boxed WARNING, with Medication Guide.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call
1-800-FDA-1088.
This product information is intended for US health care professionals only.
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