AstraZeneca reports data from Novel START trial of Symbicort Turbuhaler to relieve inflammation in mild asthma

New data from Novel START, an open-label trial designed to reflect real-world practice , has demonstrated the effectiveness of Symbicort Turbuhaler (budesonide/formoterol) as a potential anti-inflammatory reliever in mild asthma. These results are published in the New England Journal of Medicine and are being presented at the American Thoracic Society 2019 International Conference.

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. 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.

About Novel START Novel START (Novel Symbicort Turbuhaler Asthma Reliever Therapy) is Externally Sponsored Scientific Research (ESR). The primary objective of the trial was to assess the efficacy of Symbicort Turbuhaler given as an anti-inflammatory reliever as-needed in adults with mild asthma. The 52-week pragmatic trial supports the findings of the double-blind, double-dummy SYGMA trials (also published in the New England Journal of Medicine), but in an open-label treatment regimen reflecting real-world practice in 668 patients aged 18-75 years in Australia, Italy, New Zealand and the UK with a self-reported doctor-diagnosis of asthma. Patients were enrolled if they had used a SABA inhaler as sole asthma therapy in the previous 3 months and required use of SABA on more than 2 occasions in the previous 4 weeks (but on average more then 2 occasions per day in the previous 4 weeks). In the trial, Symbicort Turbuhaler as-needed (200/6 µg; n=220) was compared to SABA treatment with albuterol (known as salbutamol in many countries) as-needed (100 ?g; n=223), and maintenance ICS therapy with budesonide twice-daily plus albuterol as-needed (200 µg and 100 ?g, respectively; n=225). These comparators reflect two of the treatment options most commonly used in clinical practice for the management of mild asthma.

The results of the primary outcome measurements are : Symbicort Turbuhaler demonstrated a 51% reduction in the rate of annual asthma exacerbations versus SABA treatment with albuterol as-needed (absolute rate 0.195 vs 0.400 per patient per year, respectively; relative rate 0.49 (95% CI 0.33 to 0.72), P<0.001). There was no difference in the exacerbation rate between Symbicort Turbuhaler as-needed and maintenance budesonide plus as-needed albuterol (absolute rate 0.195 and 0.175 per patient per year, respectively; relative rate 1.12 (95% CI 0.70 to 1.79), P=0.65). (The mean budesonide dose with Symbicort Turbuhaler as-needed and maintenance budesonide was 107 µg/day and 222 µg/day, respectively.).

See- Beasley RW, Holliday M, Reddel HK, et al. Controlled trial of budesonide-formoterol as needed for mild asthma. N Engl J Med. 2019; Epub ahead of print (DOI: 10.1056/NEJMoa1901963).