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The need for pediatric studies of allergy and asthma medications

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Abstract

For many years, clinicians have accepted the fact that most medications do not have dosing guidelines for children younger than 12 years of age. Recently, there has been a great effort to correct this deficiency. With the introduction of the 1997 Food and Drug Administration Modernization Act, a provision was established to grant additional market exclusivity to pharmaceutical firms that performed the required studies that would lead to improved labeling of medications for children. This effort has resulted in a significant advance for the management of asthma and allergic disorders in children. Several allergy and asthma medications are now approved for use in children as young as 1 year of age, with studies currently being conducted in younger age groups. In this review, we discuss the background for this effort and the continuing impact it will have on the future management of allergy and asthma in children.

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References and Recommended Reading

  1. Wahn U, von Mutius E: Childhood risk factors for atopy and the importance of early intervention. J Allergy Clin Immunol 2001, 107:567–574. The increasing prevalence of atopic diseases, including asthma, is discussed. It presents the concept of asthma as a result of an "atopic march." The review raises the question of whether appropriate intervention steps could alter the natural history of atopic disease, including asthma.

    Article  PubMed  CAS  Google Scholar 

  2. Spahn JD, Covar RA, Gleason MC, et al.: Pharmacologic management of asthma in infants and small children. In Textbook of Pediatric Asthma. Edited by Naspitz CK, Szefler SJ, Tinkelman D, Warner JO. London: Martin Dunitz; 2001:121–147.

    Google Scholar 

  3. Spahn JD, Szefler SJ: Childhood asthma: new insights into management. J Allergy Clin Immunol 2002, 109:3–13. This review article highlights the current management strategies in childhood asthma and the lessons we have learned regarding the NHLBI Childhood Asthma Management Program [26]. It also identifies opportunities to improve asthma management in children.

    Article  PubMed  Google Scholar 

  4. National Asthma Education and Prevention Program Report: Guidelines for the diagnosis and management of asthma: update on selected topics—2002. J Allergy Clin Immunol 2002, 110:S141-S219. This summary was prepared by the National Asthma Education and Prevention Program to comprehensively address the revisions to the 1997 Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma. It provides a detailed summary of the rationale for these changes, which was derived following a thorough evidencebased review of the literature.

    Article  Google Scholar 

  5. Liu AH, Szefler SJ: Advances in childhood asthma: hygiene hypothesis, natural history and management. J Allergy Clin Immunol 2003, 111:S785-S792.

    Article  PubMed  Google Scholar 

  6. Covar RA, Spahn JD, Szefler SJ: Special considerations for infants and young children. In Pediatric Allergy: Principles and Practice. Edited by Leung DYM, Sampson H, Geha R, Szefler SJ. St. Louis: Mosby; 2003:379–391.

    Google Scholar 

  7. Szefler SJ: New directions in asthma therapy. In Pediatric Allergy: Principles and Practice. Edited by Leung DYM, Sampson H, Geha R, Szefler SJ. St. Louis: Mosby; 2003:465–472.

    Google Scholar 

  8. Warner JO, for the ETAC Group: A double-blinded, randomized placebo controlled trial of cetirizine in preventing the onset of asthma in children with atopic dermatitis: 18 months’ treatment and 18 months’ post-treatment follow up. J Allergy Clin Immunol 2001, 108:929–937.

    Article  PubMed  CAS  Google Scholar 

  9. Leung DYM, Boguniewicz M: Advances in allergic skin diseases. J Allergy Clin Immunol 2003, 111:S805-S812.

    Article  PubMed  CAS  Google Scholar 

  10. Milgrom H, Fick RB, Su JQ, et al.: Treatment of allergic asthma with monoclonal anti-IgE antibody. N Engl J Med 1999, 341:1966–1973.

    Article  PubMed  CAS  Google Scholar 

  11. Soler M, Matz, J, Townley R, et al.: The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J 2001, 18:254–261.

    Article  PubMed  CAS  Google Scholar 

  12. Holgate S, Bousquet J, Wenzel S, et al.: Efficacy of omalizumab, an anti-immunoglobiln E antibody, in patients at high risk of serious asthma-related morbidity and mortality. Curr Med Res Opin 2001;17:233–240.

    Article  PubMed  CAS  Google Scholar 

  13. Lemanske RF, Nayak A, McAlary M, et al.: Omalizumab improves asthma-related quality of life in children with allergic asthma. Pediatrics 2002, 110(5). http://www.pediatrics.org/cgi/content/full/110/5/e55. Accessed August 22, 2003.

  14. Shirkey H:. Therapeutic orphans [editorial]. J Pediatr 1968, 72:119–120.

    Article  PubMed  CAS  Google Scholar 

  15. Szefler SJ: Meeting the needs of the modernization act: challenges in developing pediatric therapies. J Allergy Clin Immunol 2000, 6(3 Suppl):115–117.

    Article  Google Scholar 

  16. Giacoia GP: Incentive to study drugs in children and other governmental initiatives: Will patients with asthma benefit? J Allergy Clin Immunol 2000, 106(3 Suppl):118–124. This review is part of a supplement that was prepared for the Journal of Allergy and Clinical Immunology on the impact of the 1997 Food and Drug Modernization Act. Dr. George Giacoia, a leader in the National Institutes of Child Health and Human Development efforts to improve medication labeling for children, addresses the impact of these new initiatives on the management of asthma.

    Article  Google Scholar 

  17. Food and Drug Administration: Modernization Act of 1997, Sect 111, Pub L 105-115. Rockville, MD: FDAMA; 1997.

    Google Scholar 

  18. Knorr B, Franchi LM, Bisgaard H, et al.: Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics 2001, 108:1–10.

    Article  Google Scholar 

  19. Szefler SJ, Eigen H: Budesonide inhalation suspension: a nebulized corticosteroid for persistent asthma. J Allergy Clin Immunol 2002, 109:729–742.

    Article  Google Scholar 

  20. Castro-Rodriguez JA, Holberg CJ, Wright AL, Martinez FD: A clinical index to define risk of asthma in young children with recurrent wheezing. Am J Respir Crit Care Med 2000, 162:1403–1406. This original research publication presents the concept of an Asthma Predictive Index. Based on a careful review of data in the Children’s Respiratory Study in Tuscon, the investigators present risk factors that are associated with the development of persistent asthma.

    PubMed  CAS  Google Scholar 

  21. Szefler SJ: Challenges in assessing outcomes for pediatric asthma. J Allergy Clin Immunol 2001, 107(5 Pt 2):S456-S464.

    Article  PubMed  CAS  Google Scholar 

  22. HHS News: US Department of Health and Human Services. HHS identifies drugs for pediatric testing and announces $93 million in FY 2003 and FY 2004 funding. Available at: www.hhs.gov/news. Accessed January 21, 2003.

  23. Bisgaard H: A randomized trial of montelukast in respiratory syncytial virus postbronchiolitis. The Study Group on Montelukast and Respiratory Syncytial Virus. Am J Respir Crit Care Med 2003, 167:379–383.

    Article  PubMed  Google Scholar 

  24. Szefler SJ, Simoes EAF: Montelukast for respiratory syncytial virus bronchiolitis. Am J Respir Crit Care Med 2003, 167:290–291.

    Article  PubMed  Google Scholar 

  25. Matz J, Emmett A, Rickard K, Kalberg C: Addition of salmeterol to low-dose fluticasone versus higher-dose fluticasone: an analysis of asthma exacerbations. J Allergy Clin Immunol 2001, 107:783–789.

    Article  PubMed  CAS  Google Scholar 

  26. The 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.

    Article  Google Scholar 

  27. Martinez FD, Wright AL, Taussig LM, et al.: Asthma and wheezing in the first six years of life. N Engl J Med 1995, 332:133–138.

    Article  PubMed  CAS  Google Scholar 

  28. Phelan PD, Robertson CF, Olinsky A: The Melbourne Asthma Study: 1964–1999. J Allergy Clin Immunol 2002, 109:189–194. This is a comprehensive summary of the information gained from the long-term follow-up of patients with varying levels of asthma severity and especially the long-term outcomes on pulmonary function.

    Article  PubMed  Google Scholar 

  29. Payne DNR, Balfour-Lynn IM: Children with difficult asthma: a practical approach. J Asthma 2001, 38:189–203.

    Article  PubMed  CAS  Google Scholar 

  30. Chan MT, Leung DYM, Szefler SJ, Spahn JD: Difficult-to-control asthma: clinical characteristics of steroid-insensitive asthma. J Allergy Clin Immunol 1998, 101:594–601.

    Article  PubMed  CAS  Google Scholar 

  31. Barnes P: New targets for future asthma therapy. In New and Exploratory Therapeutic Agents for Asthma, Lung Biology in Health and Disease, Vol 139. Edited by Yeadon M, Diamont Z. New York: Marcel Dekker; 2000:361–389.

    Google Scholar 

  32. Kline JN: DNA therapy for asthma. Curr Opin Allergy Immunol 2002, 2:69–73.

    Article  Google Scholar 

  33. Akinbami LJ, Schoendorf KC: Trends in childhood asthma: prevalence, health care utilization, and mortality. Pediatrics 2002, 110:315–322.

    Article  PubMed  Google Scholar 

  34. Bauman LJ, Wright E, Leickly FE, et al.: Relationship of adherence to pediatric asthma morbidity among inner-city children. Pediatrics 2002, 110(1). Available at: http:// www.pediatrics.org/cgi/content/full/110/1/e6. Accessed August 12, 2003.

  35. Lara M, Rosenbaum S, Rachelefsky G, et al.: Improving childhood asthma outcomes in the United States: a blueprint for policy action. Pediatrics 2002, 109:919–930.

    Article  PubMed  Google Scholar 

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Authors and Affiliations

  1. National Jewish Medical and Research Center, 1400 Jackson Street, Room J304, 80206, Denver, CO, USA

    Stanley J. Szefler MD, Glenn Whelan PharmD, Melanie Gleason MS & Joseph D. Spahn MD

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  1. Stanley J. Szefler MD
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  2. Glenn Whelan PharmD
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  3. Melanie Gleason MS
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  4. Joseph D. Spahn MD
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Szefler, S.J., Whelan, G., Gleason, M. et al. The need for pediatric studies of allergy and asthma medications. Curr Allergy Asthma Rep 3, 478–483 (2003). https://doi.org/10.1007/s11882-003-0058-x

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  • DOI: https://doi.org/10.1007/s11882-003-0058-x

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