In the CAMP study, growth velocities after 4 years of budesonide DPI were similar to placebo1
Adapted from CAMP (Childhood Asthma Management Program Research Group).1
In a double-blind, multicenter study, 1041 pediatric patients (ages 5 to 12 years) with asthma were randomized to receive budesonide 200 mcg twice daily via PULMICORT TURBUHALER® (budesonide inhalation powder) (n = 311), a nonsteroidal anti-inflammatory medication (n = 312), or placebo (n = 418) over a 4- to 6-year period. In this study, the primary efficacy end point was not met.
Note: Recommended starting dosage of PULMICORT FLEXHALER for pediatric patients is 180 mcg, bid.
- Controlled clinical trials have shown that orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients.†The growth of pediatric patients receiving orally inhaled corticosteroids, including PULMICORT FLEXHALER, should be monitored routinely, and the potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks and benefits associated with alternative therapies. Each patient should be titrated to his or her lowest effective dose
- A definitive comparative therapeutic ratio between PULMICORT FLEXHALER and PULMICORT TURBUHALER has not been established. For patients who have been on PULMICORT TURBUHALER, the dose of PULMICORT FLEXHALER may not be predicted by the dose of that product. The clinical response to PULMICORT FLEXHALER, compared with PULMICORT TURBUHALER, tends to be lower (see Clinical Studies in full Prescribing Information)
- Mean projected final adult height suggested that children in all of the study groups would achieve similar final adult heights1
- Conclusions drawn from this study may be confounded by the unequal use of corticosteroids in the treatment groups and inclusion of data from patients attaining puberty during the course of the study
- Overall, this long-term study with budesonide DPI showed a 1.1-cm reduction in growth rate during the first year of treatment; however, projected final adult height was not significantly affected1
Children attained target adult height after long-term treatment with budesonide2,3
Adapted from Agertoft et al.3
- Budesonide was administered via TURBUHALER or pressurized metered-dose inhaler at varying dosages2
- Growth rate was significantly reduced during the first years of budesonide treatment; however, final adult height was not significantly affected2
- Controlled clinical studies have shown that orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. ‡The growth of pediatric patients receiving orally inhaled corticosteroids, including PULMICORT FLEXHALER, should be monitored routinely. The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the risks and benefits associated with alternative therapies
- Note: Recommended starting dosage of PULMICORT FLEXHALER for pediatric patients is 180 mcg,
1 inhalation twice daily
A prospective study of 211 children aged 3 to 13 years who were followed for a mean of 9.2 years: 142 budesonide-treated children with mild or moderate asthma (mean daily dose 412 mcg), 18 control patients with asthma who had never received ICSs, and 51 healthy siblings of patients in the budesonide group, who also served as controls. Budesonide was administered via TURBUHALER or pressurized metered-dose inhaler.
Budesonide showed no significant Hypothalamic-pituitary-adrenal (HPA)-axis suppression in adults and children with asthma4,5
- Because studies in humans cannot rule out the possibility of fetal harm, PULMICORT FLEXHALER should be used in pregnancy only if clearly needed
- Since budesonide is absorbed into the circulation and can be systemically active, the beneficial effects of PULMICORT FLEXHALER in minimizing HPA**-axis dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose
- Since individual sensitivity to effects on cortisol production varies, physicians should consider this information when prescribing PULMICORT FLEXHALER
An open-label, 52-week trial involving 1133 patients with mild to severe asthma who received budesonide via PULMICORT TURBUHALER (dose range, 200 to 1600 mcg/day). Patients included adults (n=249) who did not receive corticosteroids, adults (n=384) and children (n=356) previously maintained on ICSs, and adults (n=144) previously maintained on oral corticosteroids. Patients were aged 6 to 70 years (mean age 33 ± 18 years).
Reassurance of the well-established safety profile of budesonide
- In non–placebo-controlled long-term studies in children (at doses up to 360 mcg daily) and adolescent and adult subjects (at doses up to 720 mcg daily) treated for up to 1 year with PULMICORT FLEXHALER, a similar pattern and incidence of adverse events were revealed
References
- Childhood Asthma Management Program Research Group. Long-term effects of budesonide or nedocromil in children with asthma. N Engl J Med. 2000;343:1054-1063.
- Agertoft L, Pedersen S. Effect of long-term treatment with inhaled budesonide on adult height in children with asthma. N Engl J Med. 2000;343:1064-1069.
- Agertoft L, Pedersen S. Effects of long-term treatment with an inhaled corticosteroid on growth and pulmonary function in asthmatic children. Respir Med. 1994;88;373-381.
- Data on file, DA-PTH-04.
- Tinkelman DG, Bronsky EA, Gross G, Schoenwetter WF, Spector SL. Efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) during 52 weeks of treatment in adults and children with persistent asthma. J Asthma. 2003;40:225-236.