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PEDIATRICS Vol. 114 No. 1 July 2004, pp. 325

Are Inhaled Corticosteroids Safe and Effective in Infants With Asthma-Like Symptoms?

M. O. Hoekstra, MD, PhD*
B. Kapitein, MD*
C. K. van der Ent, MD, PhD{ddagger}
H. G. M. Arets, MD, PhD{ddagger}
* Centre for Pediatric Allergology
{ddagger} Pediatric Pulmonology
Wilhelmina Children’s Hospital
University Medical Centre
3508 AB, Utrecht, The Netherlands

To the Editor. —

As reported in Pediatrics, Bisgaard et al1 compared safety and efficacy of fluticasone propionate and sodium cromoglycate in 1- to 3-year-old preschool children with mild to moderate recurrent wheeze in a randomized, parallel-group, open-label, 1-year-long study. They concluded that 100 µg of fluticasone propionate twice daily in these children had no effect on growth and no other important clinical side effect but was more efficacious than sodium cromoglycate. Although we acknowledge the importance of this study in this very young age group with symptoms that are very prevalent, we feel the need to challenge the authors with several comments.

First, in the article, different characterizations of the patients are given: "recurrent wheeze," "a documented history of recurrent cough or wheeze," "mild to moderate recurrent wheeze," "mild to moderate persistent wheeze with a documented history of persistent/recurrent cough, wheeze, and/or asthma-like symptoms," "persistent/recurrent wheeze," and "recurrent asthma-like symptoms." From the literature, it is known that infants with "asthma-like symptoms" can be divided into groups of either infants with virus-induced wheeze characterized by symptom-free periods or infants with persistent complaints even between periods of exacerbations.2 It is also generally accepted that inhaled corticosteroids are effective in the latter group and not in the former.3 So, to which group of infants can the findings of this study be extrapolated?

Second, the authors state that participants were discontinued from the study if they fell beyond the 5th to 95th percentiles for height and/or weight during the study. This statement is surprising, knowing that growth rate was a major outcome parameter in this study. How many patients discontinued the study treatment? Were they excluded from the analysis also?

Third, approximately one third of all children were already on inhaled steroids at the start of the study. Growth disturbance caused by inhaled corticosteroids is most often observed shortly after the start of treatment. Did the authors analyze growth and growth velocity in the steroid-naive subjects separately?

Fourth, although objective outcome measures were used in the evaluation of safety, we wonder if the person who determined these parameters was kept blind for the study drug used by the individual patients.

Last, because the study was not designed to evaluate efficacy and subjective outcome measures are used for the evaluation of efficacy in an open-label study, do the authors agree that caution should be applied in interpreting efficacy?

REFERENCES

  1. Bisgaard H, Allen D, Milanowski J, Kalev I, Willits L, Davies P. Twelve-month safety and efficacy of inhaled fluticasone propionate in children aged 1 to 3 years with recurrent wheezing. Pediatrics. 2004;113(2) . Available at: www.pediatrics.org/cgi/content/full/113/2/e87
  2. Bisgaard H. Persistent wheezing in very young preschool children reflects lower respiratory inflammation. Am J Respir Crit Care Med. 2001;163 :1290 –1291[Free Full Text]
  3. Kaditis AG, Gourgoulianis K, Winnie G. Anti-inflammatory treatment for recurrent wheezing in the first five years of life. Pediatr Pulmonol. 2003;35 :241 –252[CrossRef][ISI][Medline]
PEDIATRICS (ISSN 1098-4275). ©2004 by the American Academy of Pediatrics




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