Purpose of the Study. To study the incidence of local side effects after inhaled corticosteroid use. There have been few studies in children documenting potential local effects. Identification and counseling for these potential effects may improve patient care and compliance.
Study Population. A total of 639 children with known asthma taking daily inhaled corticosteroid (budesonide or beclomethasone) therapy were divided into 2 groups, <6 and >6 years old.
Methods. Patients were prospectively enrolled in this cohort study. Clinical examination was performed and a questionnaire survey was completed by the patient and parent for symptoms during the previous month.
Results. Of the 639 children, the mean age was 75.9 ± 48.9 months (range: 3 months–16 years) and 61.3% were boys. In the beclomethasone (BDP) group, statistically significant variables included younger age, greater proportion of boys, lower steroid dose, and use of a pressurized metered-dose inhaler (pMDI). For both drugs the overall reported local side effects included at least 1 side effect in 61.5% of children, cough during inhalation in 39.7%, thirsty feeling in 21.9%, dysphonia in 14%, oral candidiasis in 10%, and perioral dermatitis in 2.9%. The incidence of cough during inhalation was doubled (53.7% vs 25.5%) when a spacer was used. Cough and perioral dermatitis were reported more frequently in children <6 years old while hoarseness was more common in older children. Incidence of oral candidiasis was unchanged regardless of the inhaler device or mouth-rinsing.
Reviewers’ Comments. The weakness of this study was recall bias during data collection and effects of confounding variables. Cough incidence either daily or with inhaler use was reported overall in 93% of patients. Although cough was concluded to be attributable to the spacer, this group also had a statistically significant younger patient age, male sex, and greater daily albuterol use suggesting other possibilities. Spacers clearly deliver inhaled medications more effectively to the small airways and should be a cornerstone of therapy. The lack of association between mouth-washing, inhaler device, and incidence of oral candidiasis is interesting. However, their criteria for candidiasis was frank thrush and this may have been underestimated. Recognition of potential local side effects and discussion with the family before medication initiation can promote better provider-patient relationships and hopefully improve medication compliance.
- Copyright © 2002 by the American Academy of Pediatrics