Rethinking how we manage mild asthma

Results of two recently published studies suggest that for patients with mild asthma, clinicians may need to rethink the current recommended treatment algorithm. The Novel START trial that use of budesonide-formoterol (Symbicort Turbuhaler—AstraZeneca) as needed was superior to albuterol as needed to prevent asthma exacerbations in patients with mild asthma. The SIENA trial that many patients with mild, persistent asthma have a low sputum eosinophil level and do not derive additional benefit from treatments such as mometasone (Asmanex—Merck) or tiotropium (Spiriva—Boehringer Ingelheim).

“Asthma attacks are a major burden in mild disease. Short-acting beta-agonist (SABA) relievers do not address the underlying inflammation in asthma, and patients with mild disease who rely on SABA alone are at greater risk of asthma attacks than those taking an anti-inflammatory therapy,” Richard Beasley, professor and director of the Medical Research Institute of New Zealand, in an AstraZeneca press release on the Novel START trial findings.

James Kiley, PhD, director of the Division of Lung Diseases at the National Heart, Lung, and Blood Institute (NHLBI), said the [SIENA] research underscores the value of customizing treatments to help people with asthma. “This study adds to a growing body of evidence that different patients with mild asthma should be treated differently, perhaps using biomarkers like sputum eosinophils to select which drugs should be used—a precision medicine approach,” he in an NHLBI news release.

Novel START

This 52-week, open-label study evaluated three treatment regimens in 668 patients with mild asthma. Eligible patients were those who used a SABA inhaler as their sole asthma therapy in the previous 3 months and required use of a SABA on two or more occasions in the previous 4 weeks (but on average, two or fewer occasions per day in the previous 4 weeks). The trial compared budesonide-formoterol as needed (200/6 µg) with albuterol as needed (100 μg) and maintenance therapy with budesonide twice daily albuterol as needed (200 µg and 100 μg, respectively).

Results of the primary outcome (the annualized rate of asthma exacerbations) showed that use of as-needed budesonide-formoterol resulted in a 51% reduction compared with use of as-needed albuterol. No significant difference was observed for the budesonide-formoterol and maintenance therapy groups.

SIENA

In this 42-week, double-blind, crossover trial, 295 patients with mild, persistent asthma were given twice-daily mometasone (220 µg ), once-daily tiotropium (5 µg), or twice-daily placebo. The patients were categorized according to their sputum eosinophil level (<2% vs. ≥2%), with 73% of patients having a low eosinophil level. Results of the primary outcome (responses to treatment) showed that there was no significant difference for mometasone or tiotropium compared with placebo. However, for patients with high eosinophil levels, the response to mometasone was significantly better than the response to placebo, but the response to tiotropium was not.  

For the full article, please visit for the August 2019 issue of Pharmacy Today.