4.1 Article

Allergen-Specific Immunotherapy: Which Outcome Measures are Useful in Monitoring Clinical Trials?

期刊

出版社

W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1016/j.iac.2011.02.004

关键词

Allergic rhinoconjunctivitis; Clinical studies; Allergen-outcome parameters; Study end points; Quality of life; Specific immunotherapy; Responder-analysis; Allergen challenge

资金

  1. ALK-Abello, Denmark
  2. Allergopharma, Germany
  3. Stallergenes, France
  4. HAL, The Netherlands
  5. Artu Biologicals, The Netherlands
  6. Allergy-Therapeutics/Bencard, UK/Germany
  7. Hartington, Spain
  8. Lofarma, Italy
  9. Novartis/Leti, Germany/Spain
  10. Roxall, Germany

向作者/读者索取更多资源

Various clinical outcome measures are commonly applied in clinical trials on specific immunotherapy for allergic rhinoconjunctivitis with or without asthma to provide evidence of its clinical efficacy. These primary endpoints measure clinical symptoms as well as the use for concomitant medication. Secondary outcome endpoints are represented by health-related quality of life (HRQoL), well-days, provocation-tests, in vitro tests and others. This article reviews different methods assessing the clinical outcome of trials on both subcutaneous and sublingual immunotherapy, and highlights potential advantages and drawbacks of each method.

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