The following reporting rates of common adverse experiences are based upon 4 clinical trials in which 1196 patients (671 female and 525 male adults previously treated with as-needed bronchodilators and/or inhaled corticosteroids) were treated with QVAR (doses of 40, 80, 160, or 320 mcg twice daily) or CFC-BDP (doses of 42, 168, or 336 mcg twice daily) or placebo. Table 3 below includes all events reported by patients taking QVAR (whether considered drug related or not) that occurred at a rate over 3% for QVAR. In considering these data, difference in average duration of exposure and clinical trial design should be taken into account.
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.
Results: Exactly % of the children aged under 6 years and % of the older ones reported one local side-effect. Cough (%) was dependent on young age, use of BDP, and mainly use of spacer device, with an OR of (95% CI: –). Thirsty feeling (%) and hoarseness (%) occurred in children using ICS and long-acting β 2 -agonists. Dysphonia (%) was favored by high doses of BDP and BUD, and by inhalation from spacer devices or nebulizers. No factor favored oral candidiasis (%). Perioral dermatitis (%) and tongue hypertrophy (%) were associated with nebulization.