As-Needed Budenoside Formoterol Reduces Mild Asthma Exacerbations

Long-acting beta agonist (LABA) agent budenoside-formoterol (Symbicort) may prevent severe exacerbations in adult patients with asthma at a bettered rate than maintenance budesonide plus terbutaline, according to the findings of a recent study.

The results, which assessed the fast-onset LABA as an as-needed therapy, give support to the 2019 Global Initiative for Asthma (GINA) recommendation regarding the combination of inhaled corticosteroid and formoterol reliever therapy as an alternative to daily low-dose inhaled corticosteroid for mild asthma.

In new findings from the PRACTICAL trial—a 52-week, open-label, parallel-group, randomized controlled trial conducted across 15 facilities in New Zealand—a team of investigators compared inhaled budenoside-formoterol versus inhaled monotherapy budenoside plus terbutaline in adult patients with mild to moderate asthma.

Patients were aged 18-75 years old with a physician’s diagnosis of asthma being treated with short-acting beta antagonist (SABA) for symptom relief—with or without maintenance inhaled corticosteroids—in the past 12 weeks.

Following randomization and treatment initiation, patients were assessed at visits scheduled for weeks 4, 16, 28, 40, and 52. Investigators assessed for a primary outcome of number of severe exacerbations per patient annually, analyzed by intention to treat. Severe exacerbations were designed as systemic corticosteroid use for at least 3 days due to asthma, or hospital admission/emergency department visit due to asthma requiring systemic corticosteroids.

The analysis included 885 eligible participants administered either as-needed budesonide 200 mcg-formoterol 6 mcg (n = 437) or twice-daily maintenance budenoside 200 mcg plus terbutaline 250 mcg (n = 448).

Annual severe exacerbations were lower in patients treated with budesonide-formoterol than daily maintenance therapy (absolute rate per patient annually 0.119 vs 0.172; relative rate, 0.69; 95% CI, 0.48 — 1.00, P = .049).

Among all observed adverse events, nasopharyngitis was the most common in both treatment arms, occurring in 35% of budesonide-formoterol patients and 32% of maintenance budesonide plus terbutaline patients.

Along with supporting the new GINA recommendations for alternative daily low-dose inhaled corticosteroid options for mild asthma, the new findings rally with the Novel START trial results showing that as-needed budesonide-formoterol more effectively prevents mild asthma exacerbations than as-needed albuterol, an inhaled bronchodilator.

Those 52-week results, presented at the American Thoracic Society (ATS) 2019 International Conference this year, similarly drove the clinical advisory that budesonide-formoterol could reduce exacerbation risks in patients with mild asthma treated with SABA.

“For the patient for whom asthma symptoms rather than exacerbations are the most bothersome, maintenance treatment has value,” investigators wrote at the time.

The PRACTICAL trial investigators concluded the symptom relief combination therapy was beneficial for severe exacerbation prevention in mild to moderate asthma patients than maintenance low-dose budesonide plus as-needed terbutaline.

The study, "Budesonide-formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma (PRACTICAL): a 52-week, open-label, multicentre, superiority, randomised controlled trial," was published online in The Lancet.