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Q In patients with asthma, is budesonide (BUD) plus formoterol (FORM) (BUD+FORM) both for maintenance and symptom relief more effective than fixed dosing using BUD+FORM plus a short acting β2 agonist (SABA) or a 4 fold higher dose of BUD plus SABA for reducing the rate of severe asthma exacerbations?
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randomised controlled trial.
blinded (patients and healthcare providers).*
Follow up period:
246 centers in 22 countries
2760 outpatients 4–80 years of age (mean age 36 y, 55% female; 12% children 4–11 y of age) with asthma who were using inhaled corticosteroids.
BUD+FORM (budesonide, 80 μg, plus formoterol, 4.5 μg) both for maintenance and as needed (BUD+FORM for both, n = 925), BUD+FORM for maintenance plus terbutaline, 0.4 mg as needed (BUD+FORM plus SABA, n = 909), or budesonide high dose 320 μg for maintenance plus terbutaline as needed (BUDH plus SABA, n = 926). All maintenance treatments were twice daily for patients 12–80 years of age and once daily for children 4–11 years of age.
time to first severe asthma exacerbation (defined as deterioration in asthma resulting in hospital admission or emergency room treatment, oral steroid treatment, or morning peak expiratory flow ⩽70% of baseline on 2 consecutive d).
Patient follow up:
99.7% of patients were included in the intention to treat analyses.
Time to first severe exacerbation was greater in the BUD+FORM for both group than in the BUD+FORM plus SABA group or BUD plus SABA group (p values <0.001). Fewer patients in the BUD+FORM for both group than in the BUD+FORM plus SABA group or BUDH plus SABA group had ⩾1 severe asthma exacerbation (table).
In patients with asthma, budesonide plus formoterol (BUD+FORM) both for maintenance and symptom relief was more effective than fixed dosing using BUD+FORM plus a short acting β2 agonist (SABA) or a 4 fold higher dose of budesonide plus SABA.
A modified copy of this abstract appears in Evidence-Based Nursing.
Most asthma can be controlled by inhaled long acting β2 agonists (LABA) and corticosteroids (ICS), but this control is often inadequate in practice. 2 main combination products exist and have been associated recently with different approaches to control; the fluticasone/salmeterol combination with stepping up the dose to achieve full symptom control1 and the budesonide/formoterol (BUD+FORM) combination with varying the maintenance dose to control symptoms.2 The fast onset of bronchodilation and the dose response of formoterol prompted use of the BUD+FORM combination for regular dosing and relief in the study by O’Byrne et al. This approach provided better results, in prevention of exacerbations, than the combination or higher dose steroid alone with a SABA for relief, without adverse effects or excessive steroid doses. Benefits might be related to better adherence or intervention at the early stages of an exacerbation. Formoterol alone as relief medication has also shown benefits over a SABA.3
An important element is the corticosteroid dose chosen for the BUD+ FORM combination. Budesonide 80 μg twice daily was used although adult patients had been on ICS 400–1000 μg daily, (children 200–500 μg). This would tend to allow exacerbations, bring out the differences between approaches, and reduce the number needed to treat but might not be the dose chosen in clinical practice.
The study by O’Byrne et al shows that a flexible approach with a single inhaler can be effective but it raises the question of whether alternative approaches of complete control at higher doses, or flexibility in response to symptoms, might be chosen to suit the needs and expectations of different patients.