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Author Holgate, S.T.; Bousquet, J.; Chung, K.F.; Bisgaard, H.; Pauwels, R.; Fabbri, L.; Rabe, K.; Doherty, M.; Snell, N.J.C.; Cuss, F.; D'Amato, M.; Reginster, J.Y. url  openurl
  Title Summary of recommendations for the design of clinical trials and the registration of drugs used in the treatment of asthma Type Journal Article
  Year (down) 2004 Publication Respiratory Medicine Abbreviated Journal Respir Med  
  Volume 98 Issue 6 Pages 479-487  
  Keywords Acute Disease; Administration, Inhalation; Adult; Aged; Anti-Asthmatic Agents/*therapeutic use; Asthma/diagnosis/*drug therapy; Child; Clinical Trials as Topic/*methods; Drug Evaluation, Preclinical/methods; Humans; Nebulizers and Vaporizers; Treatment Outcome  
  Abstract With new drugs being introduced to treat asthma it is timely to review criteria that can be used to assess efficacy in clinical trials. Anti-asthma drugs are classified into symptoms-modifying, symptom preventers and disease modifying agents. Attention is drawn to the types of experimental evidence required in preclinical studies to support further clinical development of a new therapy. Clinical trials demand careful selection of patients to maximise the strength of the efficacy signal according to the type of trial being designed. While provocation tests are useful in suggesting efficacy, negative tests do not necessarily indicate lack of anti-asthma activity. Therapeutic trial designs need to take account of duration of treatment, dose-response relationships and confirmatory trials. Outcome measures include symptoms, lung function, reduction in concomitant medication, exacerbations, quality of life and measures of inflammation. Interpretation of results need to include the clinical relevance of any changes as well as statistical significance. Special consideration needs to be given to the evaluation of drugs for acute severe asthma, asthma in children and older people, co-morbidity such as rhinitis, and inhaler devices. As with all drugs introduced into practice, careful attention needs to be paid to both short- and long-term safety.  
  Address RCMB Division, School of Medicine, University of Southampton, UK. s.holgate@soton.ac.uk  
  Corporate Author Group for the Respect of Ethics and Excellence in Science: Asthma section Thesis  
  Impact Factor 03,086 First Author Holgate, S.T. Editor  
  Language English Summary Language Original Title  
  Series Editor Series Title Abbreviated Series Title  
  Series Volume Series Issue Senior Author Reginster, J.Y.  
  ISSN 0954-6111 ISBN Medium  
  Area Expedition Conference  
  Notes PMID:15191031 Approved no  
  Call Number Serial 173  
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