| 1. Is Symbicort as effective
as Pulmicort® + Oxis® in adults? |
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| 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).
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| 2. What advantage in asthma
control does Symbicort provide over inhaled corticosteroid alone? |
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| 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

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| 3. Is Symbicort more effective
than increasing the inhaled steroid dose? |
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| 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
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| 4. Does Symbicort decrease
the risk for exacerbations? |
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| 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

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| 5. Is Symbicort
effective as a once-daily therapy? |
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| 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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