Published online September 1, 2004
PEDIATRICS Vol. 114 No. 3 September 2004, pp. 904 (doi:10.1542/peds.2004-0767)
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Yes, Steroids Are Safe in Infants With Asthma-Like Symptoms

Hans Bisgaard, MD
COPSAC Clinical Research Unit,
Department of Pediatrics,
Copenhagen University Hospital,
DK-2900 Copenhagen, Denmark

David Allen, MD
Departments of Pediatrics and Pediatric Endocrinology,
University of Wisconsin Children’s Hospital,
Madison, WI 53792

J. Milanowski, MD
Department of Pulmonary Medicine,
Medical School of Lublin,
8 Jaczewskiego, 20-950, Lublin, Poland

I. Kalev, MD
Medical University Paediatric Hospital of Pulmonary Disease and Respiratory Allergy,
Sofia 1431, Bulgaria

Lisa Willits, BSc
Biomedical Data Sciences,
GlaxoSmithKline,
Middlesex UB6 0HE, United Kingdom

Patricia Davies, PhD
European Clinical Operations,
GlaxoSmithKline,
Middlesex UB6 0HE, United Kingdom

To the Editor.—

Thank you for the opportunity of replying to the letter by Hoekstra et al,1 which addresses some aspects of the design of our study published recently in Pediatrics.2

First, we need to reiterate from the article that the study is a safety study with efficacy data as secondary outcomes. We previously published articles on the efficacy of inhaled corticosteroids in infants and young children.3–5 A study designed and sufficiently powered to include both safety and efficacy as primary outcomes is beyond our ability. We made no attempt to separate the population according to trigger but recruited patients with a documented history of recurrent cough or wheeze, because we consider the safety of steroids to be independent of the trigger of the symptoms.

Second, patients were not excluded from the study if they fell outside the 5th to 95th percentiles for height and/or weight. Only those patients who fell outside these limits at baseline were excluded. In total, 122 patients were discontinued from the study and were detailed in Table 1.2 However, all data were included in the analysis up to the time of withdrawal as long as subjects had at least 1 data point on treatment.

Third, the subanalysis of the effect of steroid-naive patients was already presented (Table 3) and discussed in the article.

Fourth, this was a randomized, controlled, open trial (ie, not double-dummy), as discussed extensively in the article. Clearly, this cautions interpretation of safety as well as efficacy data. Still, we believe that we have provided the best available evidence on the safety of FP200 based on repeated slit-lamp examination in 358 toddlers and growth measurements in 524 toddlers 1 to 3 years of age followed prospectively in a randomized, controlled trial for 1 year. This database is very reassuring and suggests that the choice of steroid treatment should not be based on fear of side effects.

REFERENCES

  1. Hoekstra MO, Kapitein B, van der Ent CK, Arets HGM. Are inhaled corticosteroids safe and effective in infants with asthma-like symptoms? [letter]. Pediatrics. 2004;114 :325[Free Full Text]
  2. 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
  3. Bisgaard H, Munck SL, Nielsen JP, Petersen W, Ohlsson SV. Inhaled budesonide for treatment of recurrent wheezing in early childhood. Lancet. 1990;336 :649 –651[CrossRef][ISI][Medline]
  4. Nielsen KG, Bisgaard H. The effect of inhaled budesonide on symptoms, lung function, and cold air and methacholine responsiveness in 2- to 5-year-old asthmatic children. Am J Respir Crit Care Med. 2000;162(4 pt 1) :1500 –1506
  5. Bisgaard H, Gillies J, Groenewald M, Maden C. The effect of inhaled fluticasone propionate in the treatment of young asthmatic children: a dose comparison study. Am J Respir Crit Care Med. 1999;160 :126 –131[Abstract/Free Full Text]
PEDIATRICS (ISSN 1098-4275). ©2004 by the American Academy of Pediatrics




This Article
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