Concerns over popular combination inhalers for children with asthma that it may lead to an increased risk of asthma-related hospitalization are unwarranted, based on the results of a new study.
Advair Diskus combines a long-acting beta agonist (LABA), salmeterol, with a corticosteroid, fluticasone propionate, to reduce asthma symptoms by opening airways and reducing inflammation. Symbicort, which contains formoterol (LABA) and budesonide (corticosteroid), does the same thing.
In a 2008 analysis, the FDA found studies that seemed to indicate a connection between LABAs and asthma-related deaths in adults and hospitalizations in children. As a result, a “black box” warning –- the most stringent the FDA can require –- was placed on the label of asthma medications containing a LABA.
In one of the new trials, researchers enrolled 6,200 children with asthma between the ages of 4 and 11. They were then randomly given an inhaler that contained either salmeterol and fluticasone (the medications in Advair Diskus), or fluticasone alone.
A total of 27 children in the Advair group had a serious asthma-related event that required hospitalization, while 21 in the steroid-only group did, the researchers reported in the New England Journal of Medicine. The results indicated the risk of hospitalization was not significantly different between the 2 groups. No deaths were reported.
The Symbicort trial, also published in the New England Journal of Medicine, was designed the same way. This study enrolled 11,693 people aged 12 and older with asthma. A total of 43 patients that received Symbicort had a serious asthma-related event compared to 40 patients who only received budesonide. Again, the difference was not statistically significant.
The trials were conducted by GlaxoSmithKline and AstraZeneca, who, respectively, manufacture Advair Diskus and Symbicort. They were mandated by the FDA.
Results from both trials have been sent to the FDA for review and could lead to the lifting of the “black box” warning.