Summary

Chronic Obstructive Pulmonary Disease (COPD) is a progressive disorder associated with chronic inflammation of the airways and lungs. Persistent breathing difficulties and repeated exacerbations of COPD symptoms make the disease one of the leading causes of morbidity, and the fifth-leading cause of death in the world.

The disease is characterized by structural changes that result in a narrowing of the small airways, ultimately causing airflow limitation. Both parenchymal destruction – termed emphysema – and small airways disease – referred to as chronic bronchitis – contribute towards these changes, which occur in varying degrees in each patient.

Bronchodilators are established as the main classes of pharmacological maintenance treatment in COPD. They can be administered orally, intravenously or, if preferred, inhaled. The various forms of bronchodilators can be classed as short-acting or long-acting, and both are used in the management of COPD. Although bronchodilators play the key role in the management of COPD symptoms, other forms of treatment are also widely used. Inhaled corticosteroids (ICS) such as fluticasone propionate and budesonide are used to manage inflammation in both COPD and asthma patients. ICSs bind to the glucocorticoid receptors in the airways, reducing inflammation. In addition, there are signs of more innovative products emerging onto the treatment landscape. An example includes a monoclonal antibody – a class of therapy that has already emerged for asthma – that is in Phase III development.

The differences between many of these products are relatively nuanced, and must be understood fully by companies seeking to position a novel drug in this market. This tabular heatmap framework, designed to provide an easily digestible summary of these clinical characteristics, provides detailed information on all late-stage clinical trial results for products in the COPD market and late-stage pipeline. These are split along lines of therapy, and are therefore reflective of the treatment algorithm.

All safety and efficacy endpoints reported in these trials are displayed, for both the drug and comparison groups. In addition, key study characteristics such as the size, composition and patient segment of the study population are provided. These results are presented in a visually accessible, color-coded manner in order to maximize ease of use.

The accompanying text provides a detailed analysis of the clinical benchmarks set by the current market landscape, and the anticipated changes to these benchmarks, and to the treatment algorithm, as a result of the late-stage pipeline.

Scope

- What are the clinical characteristics of currently approved therapies for COPD, in terms of specific safety and efficacy parameters?
- What are the key unmet needs in this indication, and which clinical safety and efficacy parameters are most closely linked to them?
- Which novel classes of combination therapy are expected to emerge in the treatment of COPD?
- Which first-in-class products are in development for COPD and what targets do they act upon?
- Which sub-types of patients could potentially benefit from these new products?

Reasons to buy

- Understand the current clinical landscape by considering the treatment options available for each patient segment.
- Visually compare the currently approved treatments available at each line of therapy, based on the most important efficacy and safety parameters tested in clinical trials.
- Assess the current late-stage pipeline, in terms of the likely positioning of each product and the implications for the clinical landscape at each line of therapy.
- Understand the relative strengths and weaknesses of the studies used to gather these data.
- Build up a nuanced understanding of the clinical benchmarks set by these products, and consider how the current late-stage pipeline will affect these benchmarks.
- Assess your own pipeline programs in light of these benchmarks in order to optimally position them and maximize uptake by clinicians.