Asthma Rescue With Budesonide-Formoterol Cuts Short-Term Flare Risk

Patients with mild asthma who aren't adhering to maintenance therapy have a lower short-term risk of severe exacerbations after a single day of increased use of as-needed budesonide-formoterol, according to a post-hoc analysis from the SYGMA 1 study.

The more puffs of Symbicort a patient took, the lower the risk of a severe asthma flare over the next three weeks, Dr. Paul M. O'Byrne of McMaster University in Hamilton, Canada, and colleagues report in The Lancet Respiratory Medicine.

Published in 2018, the phase 3 SYGMA 1 trial evaluated the benefit of Symbicort when used "as needed" by adults and adolescents with mild asthma who were not on maintenance treatment. It found that patients using Symbicort had a lower long-term risk of severe asthma exacerbations than patients using the short-acting beta2 agonist (SABA) terbutaline alone.

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Symbicort, made by AstraZeneca, is a combination of the inhaled corticosteroid budesonide and the long-acting beta2-adrenergic agonist (LABA) formoterol.

"If people are adhering twice daily to their maintenance inhaled steroid, that provides the best outcome in overall control of asthma," Dr. O'Byrne told Reuters Health by phone. "But the reality is that almost all asthmatics with mild asthma will not use the maintenance medication twice daily. In that instance, using the reliever with a steroid in it is very much better than using SABA as a reliever."

Dr. O'Byrne and colleagues looked at the frequency of reliever use over a one-day period and the risk of severe exacerbation over the next 21 days in roughly 3,800 patients, age 12 and older, with mild asthma who were randomized to placebo plus as-needed terbutaline, placebo plus as-needed budesonide-formoterol, or budesonide maintenance plus terbutaline as needed.

After one day of more than two as-needed inhalations, the adjusted hazard ratio (HR) for severe exacerbation was 0.27 (P=0.0008) in the placebo plus as-needed budesonide-formoterol group and 0.39 (P=0.003) in the budesonide maintenance group, compared with the placebo plus as-needed terbutaline group.

After a day of more than four as-needed inhalations, HRs were 0.24 (P=0.003) and 0.30 (P=0.0065), respectively. Following a day with over six inhalations, HRs were 0.14 (P=0.057) and 0.43 (P=0.12), respectively.

However, the short-term risk of severe exacerbation increased in tandem with the number of puffs of as-needed terbutaline when patients weren't on maintenance therapy.

"It's getting the steroid in early in the flare-up, if you like, when people are developing symptoms, that really seems to be critically important," Dr. O'Byrne said. Most patients around the world use SABA as a reliever medication, he noted. "Over the next number of years, the tendency for physicians to prescribe SABAs will decline because of this understanding that there is now a better way to treat symptoms, even in people with mild asthma."

AstraZeneca funded the study. Dr. O'Byrne reports financial ties to the company.

—Anne Harding

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