Clinical trial design, nasal allergen challenge models, and considerations of relevance to pediatrics, nasal polyposis, and different classes of medication 

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Presentation transcript:

Clinical trial design, nasal allergen challenge models, and considerations of relevance to pediatrics, nasal polyposis, and different classes of medication  Anders Akerlund, MD, PhD, Morgan Andersson, MD, PhD, Jeffrey Leflein, MD, Torben Lildholdt, MD, PhD, Niels Mygind, MD  Journal of Allergy and Clinical Immunology  Volume 115, Issue 3, Pages S460-S482 (March 2005) DOI: 10.1016/j.jaci.2004.12.016 Copyright © 2005 American Academy of Allergy, Asthma and Immunology Terms and Conditions

Fig 1 Seasonal changes in pollen count illustrating the potential effect of variation exposure on clinical trial outcome if studies are undertaken for 2 weeks at early in season (A), at peak season (B), and late in season as pollen count falls and symptoms spontaneously improve (C). Journal of Allergy and Clinical Immunology 2005 115, S460-S482DOI: (10.1016/j.jaci.2004.12.016) Copyright © 2005 American Academy of Allergy, Asthma and Immunology Terms and Conditions

Fig 2 An imagined sigmoidal dose-efficacy curve illustrating the differences in efficacy between different doses at different parts of the curve: small dose difference and significant efficacy difference at the steep slope (A), large dose difference and nonsignificant efficacy difference at the flat top end plateau (B). NS, Nonsignificant. Journal of Allergy and Clinical Immunology 2005 115, S460-S482DOI: (10.1016/j.jaci.2004.12.016) Copyright © 2005 American Academy of Allergy, Asthma and Immunology Terms and Conditions