WARNING
Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SYMBICORT® should only be used for patients not adequately controlled on other asthma-controller medications (e.g., 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).
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SYMBICORT SUMMARY
SYMBICORT 80/4.5 and SYMBICORT 160/4.5 each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only.
SYMBICORT is indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older.
Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. 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.
SYMBICORT is NOT indicated for the relief of acute bronchospasm.
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SYMBICORT NEWS HIGHLIGHTS
Published Studies Related to Symbicort (Budesonide Inhalation)
Patient-reported outcomes in adults with moderate to severe asthma after use of budesonide and formoterol administered via 1 pressurized metered-dose inhaler. [2008.11]
BACKGROUND: Patient-reported outcomes (PROs) are important for evaluating asthma therapy. OBJECTIVE: To evaluate PROs in adults with moderate to severe persistent asthma receiving budesonide and formoterol administered via 1 pressurized metered-dose inhaler (pMDI)... CONCLUSION: Significantly greater improvements in health-related quality of life and asthma control and greater treatment satisfaction were observed with budesonide/formoterol pMDI vs placebo.
Anti-inflammatory effects of combined budesonide/formoterol in COPD exacerbations. [2008.10]
Systemic corticosteroids and additional short-acting beta2-agonists are commonly used in exacerbations of chronic obstructive pulmonary disease (COPD). In this double-blind study, the combination of a high-dose inhaled corticosteroid with a rapid-onset long-acting beta2-agonist was evaluated in the treatment of out-patient COPD exacerbations...
Onset of effect of budesonide and formoterol administered via one pressurized metered-dose inhaler in patients with asthma previously treated with inhaled corticosteroids. [2008.09]
BACKGROUND: Onset of bronchodilation of budesonide/formoterol in one pressurized metered-dose inhaler (pMDI) has not been evaluated in asthma. OBJECTIVE: To evaluate time to onset of clinically significant bronchodilation (> or = 15% improvement in forced expiratory volume in 1 second) and patient-perceived onset of effect (OE) in patients previously receiving inhaled corticosteroids... CONCLUSION: Budesonide/formoterol demonstrated a more rapid onset of clinically significant bronchodilation and a greater percentage of patients who perceived their medication working right away vs budesonide or placebo.
Effectiveness of high repeated doses of inhaled budesonide or fluticasone in controlling acute asthma exacerbations in young children. [2008.09]
OBJECTIVE: The role of inhaled corticosteroids in the treatment of acute asthma exacerbations in children is controversial. This study compared the effect of inhaled budesonide and inhaled fluticasone in controlling acute asthma exacerbations in young children at home... CONCLUSION: Acute asthma exacerbations in young children can be effectively controlled at home with the use of high repetitive doses of inhaled budesonide or inhaled fluticasone, initially together with beta(2)-agonists, given at the beginning of the attack, for a period of 4-8 days.
[Efficacy and safety of budesonide inhalation suspension nebulization by mesh nebulizer in Japanese infants and young children with bronchial asthma in 12-week, randomised, open study] [2008.08]
CONCLUSION: This study demonstrate that usage of mesh nebulizer in BIS 0.25 mg qd is effective and safe in young asthmatic children.
Clinical Trials Related to Symbicort (Budesonide Inhalation)
Symbicort Rapihaler Therapeutic Equivalence Study [Completed]
The purpose of the this study is to evaluate the efficacy and safety of 2 actuations
Symbicort®pMDI® 40/2. 25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4. 5
μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.
Long-Term Safety of Symbicort in Asthmatic Children - SAPLING [Completed]
Atlantis Symbicort [Completed]
The purpose of this study is to determine whether Symbicort compared with Advair, will be
more effective in controlling asthma in adults and adolescents.
Gemini Symbicort pMDI [Completed]
The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will
improve lung function and symptoms of adults and adolescents with asthma.
A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler® [Completed]
The purpose of this study is to determine if a flexible dose of Symbicort has a similar
effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with
additional glucocorticosteroids added.
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SYMBICORT PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Symbicort has an overall score of 8. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Symbicort review by 45 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Asthma |
| Dosage & duration: | | 1 puff twice a day (dosage frequency: twice a day) for the period of 2 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | lessened the frequency of asthma attacks particularly during a chest cold and generally day to day. |
| Side effects: | | Some change in voice or slight difference in voice strength |
| Comments: | | One puff twice a day |
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Page last updated: 2009-02-07
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