Steroids not superior to placebo in patients with mild persistent asthma and low sputum eosinophils

NIH: Inhaled steroids are often used to treat people with mild persistent asthma, but now a new study suggests that mild persistent asthma can be managed safely without daily steroid use.

The study of patients with mild persistent asthma found that inhaled steroids were no more effective than placebo in nearly three-fourths of the study patients, all older than age 12. Inhaled steroids were better than placebo for a subset of the patients who had high levels of eosinophils, in their sputum, but they represented about a fourth of patients enrolled in the trial.

The study funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health was published online on May 19 in the New England Journal of Medicine (NEJM). The findings were also presented at the international conference of the American Thoracic Society in Dallas.

The multicenter study included 295 people over the age of 12 with mild persistent asthma. The researchers further divided the group based on low or high sputum eosinophil levels (low = less than 2%; high = greater than or equal to 2%). The subjects were randomized to three treatment groups for 12-week periods:  inhaled steroids (mometasone), long-acting muscarinic antagonists (LAMA; tiotropium), a nonsteroidal treatment for uncontrolled asthma, or placebo. By the end of the study, every participant had received each treatment.

A surprising finding of the study was that nearly 73% (n=221) of the participants were classified as having low sputum eosinophils.

·         Among those participants who were classified as “Eos-low,” the number who responded better to active treatment with steroids was no different than the number who responded better to placebo, whereas, those who were classified as “Eos-high” were nearly three times as likely to respond to inhaled steroids than placebo.

·         Among those who were ‘Eos-low’ and had a better response to one of the treatments, 60% had superior results on LAMA, versus 40% who had better symptom control on placebo. 

Previous research has shown almost 50% of patients with mild persistent asthma have less than 2% eosinophils in sputum and that most patients with low eosinophils do not respond well to steroid treatment. But, sputum eosinophils are not routinely measured.

The findings of this study now indicate that it may be possible to target particular therapies to subsets of patients, such as those with high or low eosinophil biomarkers, for more effective treatments.

(Source: NIH)

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA