This document provides guidance for the clinical development and evaluation of new medicinal products for the treatment of asthma.
Keywords: Asthma, medicinal products for the treatment of asthma, asthma in children, control of asthma, asthma severity
Current effective version
Guideline on the clinical investigation of medicinal products for the treatment of asthma - Revision 1
This document is a revision of the Note for Guidance (CPMP/EWP/2922/01) which came into effect in May 2003. It should be considered as general guidance on the development of medicinal products for the treatment of asthma and should be read in conjunction with other European and ICH guidelines which may apply to this disease area and patient population. The current revision has taken into account the updated international clinical recommendations for asthma, focused on a control-based management in order to include revised concepts of the disease and new variables developed to assess the effect of medicines for asthma treatment.
English (EN) (267.7 KB - PDF)
Document history - Revision 1 (current version)
Guideline on the clinical investigation of medicinal products for the treatment of asthma - Revision 1
This document is a revision of the Note for Guidance (CPMP/EWP/2922/01) which came into effect in May 2003. It should be considered as general guidance on the development of medicinal products for the treatment of asthma and should be read in conjunction with other European and ICH guidelines which may apply to this disease area and patient population. The current revision has taken into account the updated international clinical recommendations for asthma, focused on a control-based management in order to include revised concepts of the disease and new variables developed to assess the effect of medicines for asthma treatment.
English (EN) (267.7 KB - PDF)
Overview of comments received on 'Note for guidance on clinical investigation of medicinal products for treatment of asthma' - Revision 1
Overview of comments received on 'Note for guidance on clinical investigation of medicinal products for treatment of asthma' (CHMP/EWP/2922/01/rev.1)
English (EN) (852.2 KB - PDF)
Draft note for guidance on clinical investigation of medicinal products for treatment of asthma - Revision 1
This document is intended to provide guidance for the clinical evaluation of new medicinal products for the treatment of asthma.
English (EN) (204.46 KB - PDF)
Concept paper on the need for revision of the CHMP note for guidance on the clinical development of medicinal products in the treatment of Asthma (CPMP/EWP/2922/01)
English (EN) (37.92 KB - PDF)
Document history - First version
Note for guidance on the clinical investigation of medicinal products in the treatment of Asthma
English (EN) (172.71 KB - PDF)
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