Data from the PRACTICAL study showed that budesonide-formoterol reliever therapy in a single inhaler for patients with mild to moderate asthma was associated with a 31% reduction in the risk for severe exacerbations, as compared with maintenance budesonide plus terbutaline reliever therapy.wisepoqder Formoterol powder

“The budesonide-formoterol reliever regimen in mild to moderate asthma is based on the proven efficacy of the budesonide-formoterol maintenance and reliever regimen in moderate to severe asthma,” Richard Beasley, DSc, from the Medical Research Institute of New Zealand and the Capital and Coast District Health Board, wrote in an email to Healio Pulmonology. “This regimen has the potential to overcome the problem of underuse of inhaled steroids in asthma by using the reliever as its vehicle for administration.”
Investigators conducted the open-label, parallel-group, superiority trial at 15 primary care or hospital-based clinical trial units and primary care practices in New Zealand. They randomly assigned 890 adults aged 18 to 75 years with asthma to reliever therapy with one inhalation of budesonide 200 g–formoterol 6 g (Symbicort Turbuhaler, AstraZeneca) as needed or maintenance budesonide 200 g (Pulmicort Turbuhaler, AstraZeneca) twice daily plus two inhalations of terbutaline 250 g (Bricanyl Turbuhaler, AstraZeneca; not available in the U.S.) as needed.

All patients were using short-acting beta-agonists for symptom relief with or without maintenance low to moderate doses of inhaled corticosteroids during the previous 12 weeks. The study included six visits over 52 weeks and the primary outcome was the number of severe exacerbations per patient per year.

Fewer exacerbations

The final analysis included 885 patients. Results showed that the rate of severe asthma exacerbations was lower in the as-needed budesonide-formoterol group than in the maintenance budesonide plus as-needed terbutaline group (relative rate = 0.69; 95% CI, 0.48-1), as was the rate of combined moderate and severe asthma exacerbations (relative rate = 0.7; 95% CI, 0.51-0.95). Both time to first severe exacerbation and time to first moderate or severe exacerbation were longer with budesonide-formoterol vs. maintenance budesonide plus as-needed terbutaline, the researchers noted.

The most common adverse event in both treatment groups was nasopharyngitis, occurring in 35% of patients receiving as-needed budesonide-formoterol and 32% of those receiving maintenance budesonide plus as-needed terbutaline.

“This is the first independent study showing that budesonide-formoterol reliever therapy outperforms maintenance inhaled corticosteroid and [short-acting beta-agonist (SABA)] reliever therapy in mild to moderate asthma in reducing severe exacerbation risk,” Beasley said. “Taken together with the three earlier studies of budesonide-formoterol reliever therapy in mild asthma published in The New England Journal of Medicine, and the studies of the budesonide-formoterol maintenance and reliever regimen in moderate to severe asthma, there is now strong evidence that budesonide-formoterol outperforms SABA therapy across the spectrum of asthma severity.”