Safety and Tolerability
Rescue medication use of triamcinolone nasal spray was 63% higher in
the placebo group over the course of treatment (P=0.063). Prednisone use
was discouraged with utilization being the same in both groups
(P=0.972). There were no abnormalities seen on blood chemistry or liver
function tests in either group. Minor adverse events such as headache,
URI or injection site discomfort was similar in both cohorts. One
patient receiving placebo inadvertently became pregnant during the study
but had already completed therapy and reported no adverse outcomes. Two
patients receiving placebo developed an asthma exacerbation. There were
no other significant adverse events and no drop-outs.