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Study finds as-needed budesonide/formoterol superior to as-needed albuterol (salbutamol) for reducing risk of severe exacerbations in mild asthma

A study published May 19, 2019 in the New England Journal of Medicine found that the Symbicort Turbuhaler budesonide/formoterol DPI demonstrated a greater than 50% reduction in the risk of asthma exacerbations in mild asthma patients compared to as-needed albuterol (salbutamol) alone. Compared to as-needed albuterol used in conjunction with maintenance budesonide, the exacerbation rate for as-needed budesonide/formoterol was approximately the same.

The 52-week, randomized, open-label, parallel-group START study, which was funded by AstraZeneca and the Health Research Council of New Zealand, enrolled 675 adult patients with mild asthma who received either albuterol via MDI as needed; maintenance budesonide via DPI plus as-needed albuterol; or Symbicort Turbuhaler as needed.

AstraZeneca Therapy Area VP, Respiratory, Global Medical Affairs Alex de Giorgio-Miller commented, “There are an estimated 176 million asthma attacks globally each year and all asthma patients, regardless of their disease severity, are at risk of severe attacks. The Novel START trial demonstrates the effectiveness of Symbicort as an anti-inflammatory reliever to reduce the risk of asthma attacks in patients with mild disease, compared with the most commonly used asthma reliever. In a trial that reflects real-world practice, these data reinforce evidence from the SYGMA trials and build on the established clinical profile of Symbicort in moderate-to-severe disease.”

According to AstraZeneca, Symbicort Turbuhaler is currently approved as a reliever medication for mild asthma in Brazil and Russia, and the company has submitted an MAA for that indication in Europe. Symbicort MDi and/or Turbuhaler is approved to treat asthma and/or COPD in approximately 120 countries. In the US, only the MDI is approved.

Read the NEJM article.
Read the AstraZeneca press release.

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published on May 20, 2019

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