Local Side Effects of Inhaled Budesonide in Asthmatic Children- A Cross-sectional Study

Abstract

Introduction: There is scarcity of Paediatric literature regarding local side effects of Inhaled Corticosteroids (ICSs) and available paediatric literature on the subject is old and has shown variable prevalence of these side effects varying from none to 60%. Aim: To evaluate local side effects of inhaled Budesonide in asthmatic children of ≤12 years. Materials and Methods: In this cross-sectional study, 250 asthmatic children attending Paediatric chest clinic of a tertiary care hospital and taking inhaled Budesonide for at least three months were evaluated for occurrence of local side effects during preceding one month. Local side effects (dysphonia, sore throat, cough during inhalation, thirsty feeling after inhalation, oral ulcers) experienced in preceding month were asked for and clinical evaluation for oral thrush, perioral dermatitis and tongue hypertrophy was done at the time of assessment. Information was collected regarding potential risk factors associated with occurrence of these side effects. Chi-square test was used to study the association between qualitative variables. Univariate and multivariate logistic regression were used to study the association between local side effects and potential factors associated with their occurrence. Results: About 250 asthmatic children aged ≤12 years (64 children <6 years, 186 children ≥6 years) taking inhaled budesonide via pressurised Metered Dose Inhaler (pMDI) were evaluated. Almost half (48.8%) of the enrolled children experienced at least one local side effect, either daily or frequently, in the preceding month. Though majority experienced a single side effect, 21% experienced two or more side effects. Thirsty feeling after inhalation was the most common reported side effect experienced by 31.2% children followed by cough during inhalation, sore throat and dysphonia which were experienced by 25.2%, 17% and 8% children, respectively. Perioral dermatitis was found in only one patient while none of the patients had tongue hypertrophy or oral thrush. On univariate logistic regression, thirsty feeling after inhalation was associated with older age (≥6 years) and higher dose of Budesonide (>400 μg/day). Cough during inhalation was found to be associated with older age, higher dose of Budesonide, poor compliance to treatment and incorrect technique of taking pMDI and sore throat was associated with poor compliance and incorrect technique. However, on multivariate logistic regression, only cough during inhalation was found to be associated with higher dose of Budesonide and poor compliance to treatment. Conclusion: Local side effects are common in asthmatic children using ICSs and should be routinely assessed during follow-up as a part of comprehensive asthma management plan.