For patients with COPD
SYMBICORT 160/4.5 provided sustained control all-day and all-night2,3
- Nearly a 9% improvement in baseline lung function2*
- 81%† of mean peak lung function achieved within 5 minutes‡ postdose2
SYMBICORT reduced common COPD symptoms throughout the day4
- SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
- SYMBICORT 160/4.5 is dosed twice daily. See Dosing for complete information
Comparator Arms
Mean percent improvement in predose FEV1 at end of treatment (end of month 12, LOCF)
SYMBICORT 160/4.5 mcg: 8.7%
SYMBICORT 80/4.5 mcg: 5.8%
Formoterol: 6.8%
Placebo: 0%
Mean percent Improvement in postdose FEV1 in 5 minutes
Day of randomization
SYMBICORT 160/4.5 mcg: 17.65%
SYMBICORT 80/4.5 mcg: 20.3%
Formoterol: 16.5%
Placebo: 1.7%
End of treatment
SYMBICORT 160/4.5 mcg: 21.76%
SYMBICORT 80/4.5 mcg: 22.4%
Formoterol: 14.9%
Placebo: 1.9%
Study Data
SUN Study 1: 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 packs per year and at least 40 years of age 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.
The 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.
- *As measured by predose forced expiratory volume in 1 second (FEV1).
- †64.36% of observed mean peak effect was achieved within 5 minutes postdose at day of randomization; 81.01% at end of treatment.
- ‡SYMBICORT improved lung function within 5 minutes (median time to ≥15% improvement in FEV1) and was maintained over the 12-hour dosing cycle.
SYMBICORT reduced common COPD symptoms throughout the day4
Placebo Comparison
Absolute mean reduction in symptom score over 12 months with placebo: -0.38
- The Breathlessness, Cough and Sputum Scale (BCSS) measurement was a secondary end point, with the primary comparison being SYMBICORT vs placebo (P<.001 for the treatment average)4
*The 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.
Important Safety Information, including boxed WARNING
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
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.
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. Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
The most common adverse events ≥ 3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection.
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.
Indications
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 COPD
Please see full Prescribing Information
, including boxed WARNING.
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.
