Are Daily Corticosteroids Necessary for Mild Asthma? Recent Study Suggests Otherwise

June 14, 2019

According to a recent study presented at the American Thoracic Society International Conference in Dallas, Texas, and simultaneously published in the New England Journal of Medicine, nearly three-fourths of patients with mild, persistent asthma had a low sputum eosinophil levels and did not differ in their response to either mometasone or tiotropium when compared with placebo.

According to a recent study presented at the American Thoracic Society International Conference in Dallas, Texas, and simultaneously published in the New England Journal of Medicine, nearly three-fourths of patients with mild, persistent asthma had a low sputum eosinophil levels and did not differ in their response to either mometasone or tiotropium when compared with placebo.

The trial, a 42-week, double-blind study, enrolled 295 patients aged at least 12 years with mild, persistent asthma to receive twice-daily mometasone at a dose of 220 g, once-daily tiotropium at a dose of 5 g, or twice-daily placebo with each treatment period lasting 12 weeks. The primary outcome was the response to mometasone compared with placebo and tiotropium as compared with placebo among patients with a low sputum eosinophil level who had a previously identified differential response to 1 of the trial agents.

The response was evaluated by a hierarchical composite outcome that incorporated treatment failure, asthma control days, and the forced expiratory volume in 1 second. A secondary outcome was a comparison of patients with a high sputum eosinophil level and those with a low level.

The researchers found that 73% of patients had a low eosinophil level, and of these patients, 59% had a differential response to a trial agent, though there was no statistically significant difference in the response to mometasone or tiotropium compared with placebo.

Among patients with a low eosinophil level who had a differential treatment response, 57% (95% CI 48-66) had an improved response to mometasone, and 43% (95% CI 34-52) had a better response to placebo (P = 0.14), compared with 60% (95% CI 51-68) who had a better response to tiotropium, and 40% (95% CI 32-49) who had a better response to placebo (P = 0.029). Patients with a high eosinophil level, however, demonstrated a significantly better response to mometasone than the response to placebo (74% vs 26%) though the response to tiotropium was not significant (57% vs 43%).

The authors concluded that though the majority of patients with mild, persistent asthma who also had a low sputum eosinophil level did not demonstrate a significant difference in their response to either mometasone or tiotropium compared with placebo, the data “provide equipoise for a clinically directive trial to compare an inhaled glucocorticoid with other treatments in patients with a low eosinophil level,” wrote the authors.

Reference

Lazarus S, Krishnan J, King T, et al. Mometasone or tiotropium in mild asthma with a low sputum eosinophil level. N Engl J Med. 2019;280:2009-2019. https://www.nejm.org/doi/full/10.1056/NEJMoa1814917. Accessed June 14, 2019.