AstraZeneca PLC's Symbicort Turbuhaler reduced the number of annual asthma attacks by 51% when compared to salbutamol, also known as GlaxoSmithKline PLC's Ventolin, in a study that suggests it could potentially be used to treat mild asthma.
AstraZeneca's inhaled medicine is already approved to treat moderate to severe asthma, and the company is awaiting a decision by European regulators on whether to approve it for additional use in mild asthma.
No difference in the number of attacks was observed when Symbicort Turbohaler was compared with twice daily budesonide plus albuterol. Results of the study have been published in the New England Journal of Medicine and were presented at the American Thoracic Society 2019 International Conference on May 19. The study was carried out by the Medical Research Institute of New Zealand and funded in part by a research grant from AstraZeneca.
Dubbed the Novel START trial, its primary objective was to assess the efficacy of Symbicort Turbuhaler given as an anti-inflammatory reliever as-needed in adults with mild asthma compared with albuterol, also known as salbutamol, which is a short-acting beta-agonist inhaled medicine. Symbicort, which combines a long-acting beta agonist with an inhaled corticosteroid, was approved for use in moderate to severe asthma and chronic obstructive pulmonary disorder, also known as smoker's cough, in 2000.
"Typically, for an asthma patient, a SABA [short-acting beta-agonist] reliever would be the first medicine that patients are prescribed upon diagnosis, and the prescription and dispensing of SABA relievers is huge globally, let's say 170 million globally in a year, the single most commonly prescribed medicine for patients suffering from asthma," said Tom Keith-Roach, senior vice president of AstraZeneca's respiratory unit, in an interview. "And whilst a SABA gives the patient the sensation of short-term relief, it doesn't include an anti-inflammatory reliever or have an anti-inflammatory effect — so no matter how many times a patient might puff, it can't actually address the underlying inflammation."
Asthma, which affects up to 339 million adults and children across the world, is characterized by intermittent breathlessness and wheezing. The reliever market is worth $4.4 billion annually. Although there are an estimated 176 million asthma attacks globally every year, patients often under-use their anti-inflammatory "preventer" therapy and are overly dependent on their SABA reliever, which can hide the fact that symptoms are worsening.
To address this issue, new guidelines were recently issued by the Global Initiative for Asthma consortium of respiratory experts, recommending the use of a combination of an anti-inflammatory therapy and a long-acting beta agonist, or LABA, instead of the SABA inhalers.
"[These guidelines] are overturning decades of asthma treatment practice," said AstraZeneca's Keith-Roach. "They called it a revolutionary change, a landmark change, a fundamental change in how we think about asthma," he said. Still, "it's not going to happen overnight," he added.