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Summary of recommendations for the design of clinical trials and the registration of drugs used in the treatment of asthma.

机译：关于设计临床试验和治疗哮喘的药物注册的建议摘要。

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摘要

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.
机译：随着引入治疗哮喘的新药物，应及时审查可用于评估临床试验疗效的标准。抗哮喘药可分为缓解症状，预防症状和改善疾病的药物。注意临床前研究中需要的实验证据类型，以支持新疗法的进一步临床开发。临床试验要求仔细选择患者，以根据设计的试验类型最大化疗效信号的强度。虽然激发试验可用于提示疗效，但阴性试验未必表明缺乏抗哮喘活性。治疗性试验设计需要考虑治疗的持续时间，剂量反应关系和确证试验。结果指标包括症状，肺功能，减少用药，恶化，生活质量和炎症指标。结果的解释需要包括任何变化的临床相关性以及统计学意义。需要特别考虑评估急性严重哮喘，儿童和老年人哮喘，鼻炎等合并症和吸入器的药物。与所有引入实践的药物一样，需要对短期和长期安全性都给予认真的关注。

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