Clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD)
| Current effective version |
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| Reference number | EMA/CHMP/483572/2012 |
| Published | 09/08/2012 |
| Effective from | 01/09/2012 |
| Keywords | Chronic obstructive pulmonary disease (COPD), airflow obstruction, relief of symptoms, maintenance treatment |
| Description | 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. |
Document history
First version Current version | In operation: 01/09/2012–present Published: 22/11/2012 Published: 20/09/2010 Published: 19/0/2009 | |
| Superseded document |
 Points to consider
| Pubished: 19/05/1999 |
Related content
- 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