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- W4235200804 abstract "We thank Drs Buzzetti, D'Amico, and Addis for their interest in our paper.1Simons FER Villa JR Lee BW Teper AM Lyttle B Aristizabal G et al.Montelukast added to budesonide in children with persistent asthma: a randomized, double-blind, crossover study.J Pediatr. 2001; 138: 694-698Abstract Full Text Full Text PDF PubMed Scopus (174) Google Scholar Information about the number of children included and excluded during the prerandomization run-in is not typically reported in prospective, double-blind, controlled clinical trials in children with asthma.2Knorr B Matz J Bernstein JA Nguyen H Seidenberg BC Reiss TF et al.Montelukast for chronic asthma in 6- to 14-year-old children. A randomized, double-blind trial.JAMA. 1998; 279: 1181-1186Crossref PubMed Scopus (509) Google Scholar, 3Childhood Asthma Management Program Research Group Long-term effects of budesonide or nedocromil in children with asthma.N Engl J Med. 2000; 343: 1054-1063Crossref PubMed Scopus (1281) Google Scholar, 4Simons FER Canadian Beclomethasone Dipropionate-Salmeterol Xinafoate Study Group A comparison of beclomethasone, salmeterol, and placebo in children with asthma.N Engl J Med. 1997; 337: 1659-1665Crossref PubMed Scopus (299) Google Scholar The run-in period is essentially a baseline screening period characterized not only by evaluation of inclusion and exclusion criteria, but also by teaching and assessment of each child, particularly with regard to ability to use inhaler devices and peak flow meters and to perform spirometry. In some centers, children are rigorously screened before entering the run-in period and the rate of exclusion before randomization is low. In other centers, children are minimally screened before entering the run-in period, and the rate of exclusion before randomization is high. Our reasons for excluding the 46 children after randomization are clearly outlined in the paper and are valid.1Simons FER Villa JR Lee BW Teper AM Lyttle B Aristizabal G et al.Montelukast added to budesonide in children with persistent asthma: a randomized, double-blind, crossover study.J Pediatr. 2001; 138: 694-698Abstract Full Text Full Text PDF PubMed Scopus (174) Google Scholar We state clearly in our paper that the effect of montelukast on forced expiratory volume in one second (FEV1) is “small” or “modest”1Simons FER Villa JR Lee BW Teper AM Lyttle B Aristizabal G et al.Montelukast added to budesonide in children with persistent asthma: a randomized, double-blind, crossover study.J Pediatr. 2001; 138: 694-698Abstract Full Text Full Text PDF PubMed Scopus (174) Google Scholar; however, it is consistent with clinically relevant endpoints used to characterize asthma control, including a 23% decrease in asthma exacerbations. The mean FEV1 values obscure the fact that some children responded well to montelukast, while others did not (Figure). The data from Santanello et al5Santanello NC Zhang J Seidenberg B Reiss TF Barber BL What are minimal important changes for asthma measures in a clinical trial?.Eur Respir J. 1999; 14: 23-27Crossref PubMed Scopus (206) Google Scholar to which Buzzetti et al refer, are based on an absolute increase in FEV1 in liters in adults and are not applicable to children. Our study was the first to demonstrate any significant benefit of adding any medication from any class to an inhaled glucocorticoid in children with persistent asthma. The challenge for the future is to identify children who might benefit most from a leukotriene modifier." @default.
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- W4235200804 doi "https://doi.org/10.1067/mpd.2002.120829" @default.
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