The results of four trials are in that tested the safety of combining a long-acting beta agonist (LABA) with an inhaled glucocorticoid to manage asthma.
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The four manufacturers conducted separate trials but coordinated trial methods to enable an independent oversight committee to conduct a meta-analysis of the combined data. More than 36,000 adolescents (aged 12-17 years) and adults with persistent asthma were enrolled into 26-week, multicenter, randomized, double-blind, noninferiority trials. Each trial had two treatment groups: One received inhaled glucocorticoid therapy alone and the other received an inhaled glucocorticoid plus a LABA. The primary outcome of interest was a composite of asthma-related endotracheal intubation or death. A secondary outcome of serious asthma-related events included intubation, hospitalization, or death.
In the meta-analysis there were three asthma-related intubations and two asthma-related deaths among a total of 36,010 patients. Both of the patients who died had received combination therapy. Given that hospitalizations were more frequent, the composite outcome of serious asthma-related event was more revealing. It was almost identical between the two groups (0.60% in the inhaled glucocorticoid group and 0.66% in the combined therapy group; relative risk, 1.09; 95% confidence interval, 0.83-1.43). Rates of asthma exacerbation were higher in the group receiving inhaled glucocorticoid alone (11.7% vs 9.8% in the combination therapy group).
