- Agertoft L,
- Larsen FE,
- Pedersen S
Purpose of the Study
To assess the effect of long-term treatment with inhaled budesonide on the occurrence of posterior subcapsular cataracts (PSC), bruises, and hoarseness in children with asthma.
One hundred fifty-seven asthmatic children, aged 5 to 16 years, on long-term inhaled budesonide and a control group of 111 age-matched asthmatic children who had never received exogenous steroids.
Both groups were assessed every 6 months. Slit lamp examination was performed on all the patients by the same ophthalmologist. Opacities were classified as PSC or non-PSC, which are not related to corticosteroid therapy. Both groups were examined for bruising on one forearm and one lower leg on the dominant side and the number and size were recorded. Families were asked to rate bruising tendency on scale of 1 to 10. The level of the activity was recorded on scale of 1 to 10. Also families were asked if their child had experienced hoarseness or change of voice. All of the above data recorded with no knowledge of the treatment received by the patients. Patients were excluded from the study if they received systemic steroids >2 weeks for both groups and from the control group if they received inhaled steroids for >2 weeks.
The two groups were comparable with respect to age, height and weight. The mean duration of asthma was longer and forced expiratory volume in 1 second (FEV1) was higher in the budesonide group. The mean compliance with budesonide was assessed to be 78%. The mean total accumulated dose of budesonide was 813.1 mg (249–2800), and the mean treatment duration was 4.4 years, giving a mean average daily dose of 504 μg (189–1322 μg). One patient in the budesonide group had PSC in one eye that was diagnosed 2 years before initiation of budesonide treatment. This fact was not known to the examining ophthalmologist. No other incidents of PSC were found in both groups. Three children were diagnosed with non-PSC opacities: two children in the budesonide group had congenital unilateral cataracts and 1 child in the control group had a congenital bilateral cataract. Fisher's exact test did not find an increased risk in the budesonide group (p = .46). There were no significant differences in the number of bruises, area on arm and leg covered with bruises, or and in the tendency to bruise between the two groups (p = .70, 0.97, 0.98, respectively). There was no significant difference between the two groups in the occurrence of hoarseness or any voice changes (BUD = 20%, control = 21%).
Three to 6 years of treatment of children with inhaled budesonide at an average daily dose of 504 μg is not associated with increased occurrence of PSC, bruises, tendency to bruise, hoarseness, or noticeable voice changes in children with chronic asthma.
This is a well-designed and well-controlled study with a good sample size in both the budesonide and the control group. The excellent safety profile of budesonide is clearly demonstrated. This study will help to alleviate the anxiety of parents and health care providers regarding the use of inhaled corticosteroids in the management of childhood asthma. Most of the anxieties have arisen from extrapolating side effects of systemically administered corticosteroids, or steroid use in adult populations to the inhaled forms. And the question is how many more of these studies are needed to convince people that inhaled corticosteroids are effective and safe in the treatment of childhood asthma?