Evidence summaries: new medicines: NHS UK. JUNE 2013

Asthma: beclometasone/formoterol (Fostair) for maintenance and reliever treatment

Summary

A 48-week randomised controlled trial in 1714 adults found that beclometasone/formoterol (Fostair) given as maintenance and reliever treatment was more effective than beclometasone/formoterol maintenance treatment plus as-needed salbutamol for reducing exacerbations in adults with uncontrolled asthma.
Both treatments were well tolerated but adverse drug reactions occurred more commonly with beclometasone/formoterol maintenance and reliever treatment.

Effectiveness

Compared with as-needed salbutamol, the time to first severe exacerbation was 75 days longer with as-needed beclometasone/formoterol (p=0.0005).
The yearly rate of severe exacerbations was reduced by a small but significant amount with as-needed beclometasone/formoterol (7.63 events per 100 patients per year; p<0.0001).
No comparisons are available with budesonide/formoterol (Symbicort) for maintenance and reliever treatment.

Safety
Both beclometasone/formoterol and salbutamol were well tolerated.
Similar numbers of patients in both groups experienced serious adverse events (3.7% with as-needed beclometasone/formoterol and 4.8% with as-needed salbutamol; p value not reported).

Adverse drug reactions
were significantly more common with as-needed beclometasone/formoterol (4.4% compared with 2.2% for as needed salbutamol; p=0.01).
The particles of beclometasone in Fostair are extra fine and more potent than in standard formulations of beclometasone;
100 micrograms of extra fine beclometasone in Fostair are equivalent to 250 micrograms of standard beclometasone.

Patient factors
Some people with uncontrolled asthma at step 3 may prefer to follow the traditional stepped model of asthma treatment. Others may prefer to change to maintenance and reliever treatment.
Fostair is a pressurised metered dose inhaler.
Symbicort is a dry powder inhaler (Turbohaler).

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