AZ’s new asthma data reflecting real-world practice

AstraZeneca published new data from real-world practice showing the benefit of anti-inflammatory reliever therapy at reducing the risk of severe asthma exacerbations.

New data from PRACTICAL, an independent trial, has demonstrated that Symbicort Turbuhaler (budesonide/formoterol) used as an anti-inflammatory reliever in mild-to-moderate asthma reduced the rate of severe exacerbations versus maintenance budesonide plus terbutaline taken as-needed, a comparator regimen representative of usual care. These results are published recently in The Lancet.

The open-label PRACTICAL trial compared Symbicort Turbuhaler, which contains budesonide, an inhaled corticosteroid (ICS), and formoterol, a long-acting beta2-agonist, taken only as-needed versus budesonide taken twice daily, an ICS maintenance treatment, plus terbutaline, a short-acting beta2-agonist (SABA) reliever, taken as-needed.

Symbicort Turbuhaler taken as an anti-inflammatory reliever was more effective at reducing the rate of severe exacerbations (absolute rate 0·119 versus 0·172 per patient per year; relative rate, 0·69; 95% confidence interval 0.48-1.00; p=0·049) and had a longer time to first severe exacerbation (p=0.015) versus maintenance budesonide plus terbutaline taken as-needed. This 31% reduction in severe exacerbation risk with Symbicort Turbuhaler was achieved with no statistically significant difference in asthma symptom control as measured by the Asthma Control Questionnaire (ACQ) or lung function as measured by FEV1.

Lead author and one of the investigators of the trial, Dr Jo Hardy of the Medical Research Institute of New Zealand said: “There is a substantive burden from severe asthma attacks in patients with mild-to-moderate asthma. These new data from the PRACTICAL trial demonstrate that Symbicort Turbuhaler used as-needed is superior to regular inhaled steroid therapy plus a reliever inhaler at reducing the rate of severe attacks in patients with mild-to-moderate asthma. These results build on previous findings with anti-inflammatory reliever therapy from the SYGMA and Novel START trials.”

Alex de Giorgio-Miller, Therapy Area Vice President, Respiratory, Global Medical Affairs, said: “Up to 30% of patients with mild-to-moderate asthma experience severe attacks each year. It is therefore of particular clinical interest that patients in PRACTICAL had significantly fewer severe attacks, with no statistically significant difference in either symptom control or lung function, compared to those receiving regular inhaled corticosteroid therapy. These data add to the body of evidence demonstrating the potential of Symbicort Turbuhaler as an important treatment option for patients with mild-to-moderate disease at risk of asthma attacks where licensed.”

PRACTICAL is a peer-reviewed trial that was independently funded by the Health Research Council of New Zealand.

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