Clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD) - Scientific guideline

This document provides guidance for the clinical evaluation of new medicinal products for the treatment of chronic obstructive pulmonary disease (COPD). It specifically focuses on the maintenance treatment of COPD.

Keywords: Chronic obstructive pulmonary disease (COPD), airflow obstruction, relief of symptoms, maintenance treatment

Current effective version

Guideline on clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease

Adopted Reference Number: EMA/CHMP/483572/2012 Summary:

This guideline is a revision of the CPMP Points to Consider on Clinical Investigation of Medicinal Products in the Chronic Treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD) (CPMP/EWP562/98). It is intended to update this previous guidance with new scientific knowledge of the disease as stated in new and updated clinical guidelines and to revise the requirements for the clinical investigation of medicinal products for the treatment of COPD accordingly.

Document history

Guideline on clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease

Adopted Reference Number: EMA/CHMP/483572/2012 Summary:

This guideline is a revision of the CPMP Points to Consider on Clinical Investigation of Medicinal Products in the Chronic Treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD) (CPMP/EWP562/98). It is intended to update this previous guidance with new scientific knowledge of the disease as stated in new and updated clinical guidelines and to revise the requirements for the clinical investigation of medicinal products for the treatment of COPD accordingly.

Overview of comments received on ' Guideline on Clinical Investigation of Medicinal Products in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Reference Number: EMA/CHMP/700490/2012 Summary:

Overview of comments received on ' Guideline on Clinical Investigation of Medicinal Products in the Treatment of Chronic Obstructive Pulmonary Disease (COPD) ' (EMA/CHMP/483572/2012)

Draft guideline on clinical investigation of medicinal products in the treatment of Chronic Obstructive Pulmonary Disease (COPD)

Draft: consultation closed Consultation dates: 22/07/2010 to 01/03/2011 Reference Number: CPMP/EWP/562/98 Rev. 1

Concept paper on the need for revision of the points to consider on clinical investigation of medicinal products in the chronic treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) (CPMP/EWP/562/98)

Reference Number: EMEA/CHMP/EWP/8197/2009

Points to consider on clinical investigation of medicinal products in the chronic treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)

Adopted Reference Number: CPMP/EWP/562/98 Legal effective date: 30/12/1999