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New data from AstraZeneca trial

AstraZeneca Research and Development

The company has announced new data from its Novel START trial, an open-label trial designed to reflect real-world practice.

The results demonstrated the effectiveness of Symbicort Turbuhaler (budesonide/formoterol) as a potential anti-inflammatory reliever in mild asthma, reports the company. These results are published in the New England Journal of Medicine.

Novel START trial

The trial compared Symbicort Turbuhaler with two commonly used treatment regimens in mild asthma. In real-world practice, patients typically use a short-acting beta2-agonist (SABA) reliever in response to symptoms or daily low-dose inhaled corticosteroid (ICS) maintenance therapy with a SABA reliever. In this trial, patients with mild asthma were randomised to receive either albuterol (a SABA reliever) taken as-needed, or budesonide (an ICS maintenance treatment) plus albuterol as-needed, or Symbicort Turbuhaler used as an anti-inflammatory reliever therapy taken as-needed.

Symbicort Turbuhaler demonstrated a 51% reduction in the rate of annual asthma exacerbations compared to albuterol. There was no difference in the exacerbation rate between Symbicort Turbuhaler and twice-daily maintenance budesonide plus albuterol, despite a 52% reduction in the mean steroid dose with Symbicort Turbuhaler. These data support the findings of the SYGMA 1 and 2 trials published in May 2018.

Novel START was conducted by the Medical Research Institute of New Zealand and was funded by a research grant from AstraZeneca and core institutional funding from the Health Research Council of New Zealand.

Symbicort Turbuhaler

Safety and tolerability data for Symbicort Turbuhaler as-needed were consistent with the known profile of the medicine. The most commonly reported adverse events in the Novel START trial were upper respiratory tract infection, nasopharyngitis and asthma.

Symbicort Turbuhaler is approved as a maintenance and reliever therapy in many countries for moderate-to-severe asthma, and as an anti-inflammatory reliever as-needed in patients with mild asthma in Brazil and Russia. A regulatory submission to expand the indication for Symbicort Turbuhaler as an anti-inflammatory reliever in mild asthma has been accepted in Europe. In the US, Symbicort is approved for use in a pressurised metered-dose inhaler device, but not the Turbuhaler device.