Effects of nebulized sodium cromoglycate on adult patients with severe refractory asthma

Abstract

Many patients with severe refractory asthma, which is insufficiently controlled by additional high-dose of inhaled corticosteroids, require oral corticosteroids and/or immunosuppressant. Clinicians should seek for suitable medications, for its' chronic use may induce high risk of side effects.The purpose of this study was to evaluate the efficacy and safety of nebulized sodium cromoglycate (3-4 times/day) in adult severe asthmatic patients with poorly controlled asthmatic symptoms, despite treatments with high-dose inhaled corticosteroids.Adult patients with severe asthma (n ¼ 251) were enrolled in a randomized clinical trial at 30 medical centers in Japan. Isotonic saline was used as placebo. The study was conducted for 10 weeks; with initial 2 weeks of observation followed by 8 weeks of treatments. Efficacy was primarily evaluated based on improvements in morning peak expiratory flow after treatment.All patients who applied inhalation of nebulized sodium cromoglycate (SCG group) or saline (Controls) were treated with high-dose of inhaled corticosteroids (median of beclomethasone dipropionate equivalent dose: 1600 mg/day s) and second-line control therapy including oral corticosteroids. There was no significant difference in morning peak expiratory flow between SCG group and controls. However, when patients were stratified into atopic and non-atopic groups, morning peak expiratory flow had significantly improved in the atopic SCG group compared to atopic Controls.Additional inhalation of nebulized sodium cromoglycate with inhaled corticosteroids is effective even in patients with severe atopic asthma. This finding shows that nebulized sodium cromoglycate is expected to be new second-line therapeutic option in severe asthma.

Cross‐talk of four types of RNA modification writers defines the immune microenvironment in severe asthma

“…A randomized controlled study showed that the addition of inhaled sodium cromolyn improved morning peak expiratory flow compared to inhaled corticosteroids (ICS) alone in moderate-to-severe asthma. 52 These results provide a basis for the treatment of cluster 1 with sodium cromolyn. Compared to the healthy group, the genes of cluster 2 were primarily active in the regulation of T cell activation and airway remodeling.…”

“…These results suggest that sodium cromolyn inhibited the upregulation of immune cells in cluster 1. A randomized controlled study showed that the addition of inhaled sodium cromolyn improved morning peak expiratory flow compared to inhaled corticosteroids (ICS) alone in moderate‐to‐severe asthma 52 . These results provide a basis for the treatment of cluster 1 with sodium cromolyn.…”

Systematic literature review of the clinical, humanistic, and economic burden associated with asthma uncontrolled by GINA Steps 4 or 5 treatment

“…In observational studies, lung function improved significantly for patients receiving mycophenolate mofetil 144 , tiotropium with salmeterol/fluticasone 154 , and pranlukast 119 . Azithromycin 147 , mometasone furoate 154 , and sodium cromoglicate 121 were not significantly more effective than placebo at improving lung function outcomes in any trial reported. Ciclesonide demonstrated inconsistent results, with significant improvements in some lung function measures associated with treatment 96 .…”

“…Our SLR identified 113 publications that included data related to the clinical burden of SUA. Twenty-three of these studies, reported in 21 publications, were international studies 13,[96][97][98][99][100][101][102][103][104][105][106][107][108][109][110][111][112][113][114][115] ; others reported data from Asia [14][15][16]19,[116][117][118][119][120][121][122][123][124] , Australia 21,125 , Germany 22,[126][127][128][129] , France 50,54,113,[130][131][132][133] , Italy [29][30]…”