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1.  Is Symbicort as effective as Pulmicort® + Oxis® in adults? 
 
2.  What advantage in asthma control does Symbicort provide over inhaled corticosteroid alone? 
 
3.  Is Symbicort more effective than increasing the inhaled steroid dose? 
 
4.  Does Symbicort decrease the risk for exacerbations? 
 
5.  Is Symbicort effective as a once-daily therapy? 





1. Is Symbicort as effective as Pulmicort® + Oxis® in adults?
 
The benefits of single inhaler therapy with Symbicort in patients with moderate to severe asthma were investigated in randomised, double-blind trial involving 362 adult patients whose asthma was not fully controlled by inhaled steroids alone (Zetterström et al, 2001).

Symbicort was associated with improvements in lung function, asthma symptom score, reliever-free days that were at least as great as those seen with Pulmicort + Oxis, and both treatments were significantly more effective than Pulmicort alone.Numerical advantages were observed in lung function and symptom scores during the first 30 days of treatment for Symbicort over Pulmicort + Oxis. This observation suggests that inherent differences may exist between the single inhaler Symbicort and dual inhaler therapy

.

Note: Symbicort doses are expressed as delivered doses of budesonide/formoterol (160/4.5 µg); these doses are equivalent to the metered dose of Pulmicort (budesonide 200 µg) and the metered dose Oxis (formoterol 6 µg).

 
2. What advantage in asthma control does Symbicort provide over inhaled corticosteroid alone?
 
In a 3-month study, twice daily treatment with two inhalations of Symbicort 160/4.5 µg was associated with a 16% (p<0.001) increase in the number of asthma control days* compared with an equivalent dose of budesonide alone (Zetterström, 2001).

In this study of 362 adult patients with moderate asthma, these findings correspond to a benefit of Symbicort of about 2 additional months of asthma control per year.

Additionally, the added convenience of the single inhaler may potentially increase adherence to therapy and thereby asthma control.

*An asthma control day was defined as no day or night asthma symptoms, no use of rescue medication, and no night awakenings due to asthma.

Symbicort significantly improved asthma control days over inhaled corticosteroid alone

 
3. Is Symbicort more effective than increasing the inhaled steroid dose?
 
Symbicort was shown to be more effective than a higher dose of fluticasone in 344 patients whose asthma was not fully controlled with previously administered inhaled steroids alone (Bateman et al, 2001).

Mean morning PEF increased by 27 L/min in patients receiving Symbicort compared with 8 L/min in the patients treated with a higher dose of fluticasone (p < 0.001). The greater effect of Symbicort was apparent from the first day of treatment.

A similar significant improvement in evening PEF was seen in the Symbicort group (p<0.001).

Patients treated with twice daily Symbicort160/ 4.5 µg experienced more reliever-free days (p<0.001) and were free from exacerbations for a significantly (p= 0.04) longer period of time than those treated with a higher dose of fluticasone. The relative risk of having an exacerbation was reduced by 32% in the Symbicort group.

Mild exacerbations were defined as 2 consecutive days or nights with:
• night-time awakening due to asthma
• decrease in PEF of 20% or more from baseline
• the need to use at least 4 inhalations of reliever medication over baseline during a 24-hour period.

Symbicort significantly improves morning PEF

 
4. Does Symbicort decrease the risk for exacerbations?
 
In a 3-month study involving 362 patients, two inhalations of twice daily Symbicort 160/4.5 µg significantly reduced the risk for mild exacerbations* (p=0.01) and increased the time to the first mild exacerbation (p<0.01) compared to two inhalations of twice daily Pulmicort 200 µg alone (Zetterström, 2001).


* A mild exacerbation was defined as 2 consecutive days with PEF =80% of baseline or =4 inhalations/24 h over baseline of rescue bronchodilator, or night awakening due to asthma on 2 consecutive nights.

Symbicort® increases proportion of patients free of exacerbations

 
5. Is Symbicort effective as a once-daily therapy?
 
The effectiveness of Symbicort as a once-daily therapy was assessed in a trial involving 523 patients with controlled mild-to-moderate asthma (Buhl et al, 2001).

Patients were switched from Pulmicort to Symbicort once-daily and results demonstrated:

  • an increase in morning PEF of 27 L/min – a significantly (p<0.001) greater improvement in morning PEF than once-daily Pulmicort
  • an increase in evening PEF of 17 L/min

Symbicort once daily improves morning PEF significantly more than budesonide alone

Symbicort once daily improves evening PEF significantly more than budesonide alone

 
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Adjustable maintenance dosing 
Quickly gains asthma control 
Effectively maintains asthma control 
Favourable safety profile 
Device benefits 
References 
 
Different formulations of Symbicort 
Prescribing information 
 
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