期刊
IMMUNOLOGY AND ALLERGY CLINICS OF NORTH AMERICA
卷 31, 期 2, 页码 289-+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
- ALK-Abello, Denmark
- Allergopharma, Germany
- Stallergenes, France
- HAL, The Netherlands
- Artu Biologicals, The Netherlands
- Allergy-Therapeutics/Bencard, UK/Germany
- Hartington, Spain
- Lofarma, Italy
- Novartis/Leti, Germany/Spain
- Roxall, Germany
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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