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
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.
English (EN) (207.94 KB - PDF)
Document history
Guideline on clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease
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.
English (EN) (207.94 KB - PDF)
Overview of comments received on ' Guideline on Clinical Investigation of Medicinal Products in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
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)
English (EN) (418.65 KB - PDF)
Draft guideline on clinical investigation of medicinal products in the treatment of Chronic Obstructive Pulmonary Disease (COPD)
English (EN) (207.51 KB - PDF)
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)
English (EN) (75.24 KB - PDF)
Points to consider on clinical investigation of medicinal products in the chronic treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)
English (EN) (37.05 KB - PDF)
Related content
- Clinical efficacy and safety: respiratory system
- Directive 2001/83/EC
- Clinical development of fixed combination medicinal products
- Clinical investigation of medicinal products for the treatment of asthma
- ICH E1 Population exposure: the extent of population exposure to assess clinical safety
- ICH E4 Dose response information to support drug registration
- ICH E7 Studies in support of special populations: geriatrics
- ICH E9 Statistical principles for clinical trials
- Investigation of drug interactions
- Missing data in confirmatory clinical trials
- Requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents