In a long-term safety trial in patients 12 years and older treated for 52 weeks with DULERA 100 mcg/5 mcg (n=141), DULERA 200 mcg/5 mcg (n=130) or an active comparator (n=133), safety outcomes in general were similar to those observed in the shorter 12 to 26 week controlled trials. No asthma-related deaths were observed. Dysphonia was observed at a higher frequency in the longer term treatment trial at a reported incidence of 7/141 (5%) patients receiving DULERA 100 mcg/5 mcg and 5/130 (%) patients receiving DULERA 200 mcg/5 mcg. No clinically significant changes in blood chemistry, hematology , or ECG were observed.
The aim of this article is to bring less well recognised adverse effects of inhaled corticosteroids to the attention of prescribers. Whilst inhaled steroids have a more favourable side effect profile than systemic steroids, they are not free from adverse effects. The dose of inhaled steroids used should be carefully monitored, and kept at the lowest dose necessary to maintain adequate control of the patient’s disease process. Be particularly aware of the cumulative effect of co-prescribing various dose forms of corticosteroids (inhaled, intranasal, oral and topical preparations).
Use of QVAR with a spacer device in children less than 5 years of age is not recommended. In vitro dose characterization studies were performed with QVAR 40 mcg/actuation with the OptiChamber and AeroChamber Plus ® spacer utilizing inspiratory flows representative of children under 5 years old. These studies indicated that the amount of medication delivered through the spacing device decreased rapidly with increasing wait times of 5 to 10 seconds as shown in Table 2. If QVAR is used with a spacer device, it is important to inhale immediately.