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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NEWS HIGHLIGHTS
Published Studies Related to Symbicort (Budesonide Inhalation)
An economic evaluation of budesonide/formoterol for maintenance and reliever treatment in asthma in general practice. [2009.09.19]
INTRODUCTION: In budesonide/formoterol (Symbicort(R) Turbuhaler(R), AstraZeneca, Lund, Sweden) maintenance and reliever therapy (SMART), patients with asthma take a daily maintenance dose of budesonide/formoterol, with the option of taking additional doses for symptom relief instead of a short-acting beta(2)-agonist (SABA). This study assesses the cost-effectiveness of SMART compared with usual care in patients with mild-to-moderate persistent asthma treated by general practitioners in the Netherlands from a societal perspective... CONCLUSIONS: Treating primary care patients with mild-to-moderate persistent asthma with SMART instead of ICS plus bronchodilators does not affect health outcomes and does not increase costs; therefore, is likely to be an alternative for guideline-directed treatment, from a health and economic perspective.
Airway inflammation in patients with asthma with high-fixed or low-fixed plus as-needed budesonide/formoterol. [2009.05]
BACKGROUND: Budesonide/formoterol maintenance and reliever therapy maintains asthma control and reduces exacerbation frequency compared with higher fixed-dose combination regimens. Its effects on eosinophilic airway inflammation and structure are unknown. OBJECTIVE: We sought to compare the effects of budesonide/formoterol 200/6 microg twice daily plus as-needed with budesonide/formoterol 800/12 microg twice daily on airway eosinophils and remodeling... CONCLUSION: Compared with fixed-dose combination treatment containing a 4-fold higher maintenance dose of budesonide, budesonide/formoterol maintenance and reliever therapy is associated with higher eosinophil counts, but these remain within the range associated with stable clinical control.
High-dose inhaled flunisolide versus budesonide in the treatment of acute asthma exacerbations in preschool-age children. [2009.04]
The role of inhaled corticosteroids in asthma exacerbation is debated. We compared high doses of nebulized budesonide versus high doses of nebulized flunisolide, in association with a short-acting beta-2-agonist, in the treatment of moderate asthma exacerbation in preschool children... High doses of inhaled flunisolide and budesonide are both effective in the management of moderate asthma exacerbations in pre-school-age children, but the flunisolide therapeutic effect was faster than budesonide.
Effect of formoterol with or without budesonide in repeated low-dose allergen challenge. [2009.04]
The use of combination therapy in mild asthma is debated. The current authors evaluated the effects of formoterol alone and a formoterol/budesonide combination inhaler on asthma deterioration induced by repeated low-dose allergen exposure... Signs of deteriorating asthma, provoked by low-dose allergen, are prevented by short-term use of budesonide/formoterol but not by temporary use of formoterol alone.
Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD. A double-blind, randomised, non-inferiority, parallel-group, multicentre study. [2009.02.19]
BACKGROUND: Oral corticosteroids and inhaled bronchodilators with or without antibiotics represent standard treatment of COPD exacerbations of moderate severity. Frequent courses of oral steroids may be a safety issue. We wanted to evaluate in an out-patient setting whether a 2-week course of inhaled budesonide/formoterol would be equally effective for treatment of acute COPD exacerbations as standard therapy in patients judged by the investigator not to require hospitalisation... CONCLUSION: High dose budesonide/formoterol was as effective as prednisolone plus formoterol for the ambulatory treatment of acute exacerbations in non-hospitalized COPD patients. An early increase in budesonide/formoterol dose may therefore be tried before oral corticosteroids are used. CLINICAL TRIAL REGISTRATION: NCT00259779.
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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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Symbicort has an overall score of 7.50. The effectiveness score is 9 and the side effect score is 7. 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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| | Symbicort review by 58 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | asthma |
| Dosage & duration: | | 2 puffs variable according to symptoms (dosage frequency: twice daily) for the period of 2 years continuing |
| Other conditions: | | none |
| Other drugs taken: | | ventolin | | |
Reported Results |
| Benefits: | | Able to breathe in a relaxed way without forcing the breath and without wheezing. Asthma "controlled" meaning ventolin used hardly at all (after decades of relying on it).
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| Side effects: | | Less flexible in my back and worse digestion in last couple of years since I have been taking symbicort. Also asthma nurse measured me at 5'11" when I thought I was 6'1"!
Am afraid of the long term effects of taking corticosteriods and long term beta blockers. |
| Comments: | | I was prescribed symbicort because I was using ventolin several times every day.
I have been using the 200/6 turbohaler most of the time in the past 2 years consistently 2xtwice daily until recently when I have noticed some loss of flexibility in my back and worsening indigestion (plus nervousness at using steroids); so I have been taking note of an information "wheel" from the nurse which basically tells me I can reduce dosage eventually to 1xonce a day if I am showing no symptoms. At the moment I am on 1xtwice daily which feels about right. Will ask nurse about 100/6 (which has half the steroid content) on next visit. Would like to come off completely but maybe not possible. |
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Page last updated: 2009-10-20
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