Clinical investigation of medicinal products for the treatment of asthma - Scientific guideline

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

Adopted Reference Number: CHMP/EWP/2922/01 Rev. 1 Summary:

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.

Document history - Revision 1 (current version)

Guideline on the clinical investigation of medicinal products for the treatment of asthma - Revision 1

Adopted Reference Number: CHMP/EWP/2922/01 Rev. 1 Summary:

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.

Overview of comments received on 'Note for guidance on clinical investigation of medicinal products for treatment of asthma' - Revision 1

Reference Number: EMA/CHMP/684234/2015 Summary:

Overview of comments received on 'Note for guidance on clinical investigation of medicinal products for treatment of asthma' (CHMP/EWP/2922/01/rev.1)

Draft note for guidance on clinical investigation of medicinal products for treatment of asthma - Revision 1

Draft: consultation closed Consultation dates: 01/07/2013 to 31/12/2013 Reference Number: CHMP/EWP/2922/01 Rev.1 Summary:

This document is intended to provide guidance for the clinical evaluation of new medicinal products for the treatment of asthma.

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)

Draft: consultation closed Consultation dates: 22/10/2009 to 31/01/2010 Reference Number: EMEA/CHMP/EWP/10797/2009

Document history - First version

Note for guidance on the clinical investigation of medicinal products in the treatment of Asthma

Adopted Reference Number: CHMP/EWP/2922/01 Legal effective date: 01/05/2003