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04 February 2013
EU
COPD

PROactive is a European project funded by the Innovative Medicines Initiative Joint Undertaking (IMI-JU) under the auspices of the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Remaining physically active is crucial for patients to maintain health and health related quality of life.  Decreased physical activity is a marker of a deteriorating health condition that is important and noticeable to patients.  Unfortunately there are currently no valid measures available to capture this perception directly from patients.  

The PROactive project aims to develop a new way to assess the effect of treatments like medicines, rehabilitation or surgery, with the goal of developing a tool that captures physical activity of COPD patients. To achieve this researchers and clinicians (from Belgium, Greece, Netherlands, Spain, Switzerland, and the UK), patients, pharmaceutical and other companies and the European Respiratory Society collaborate in this project. Although EFA is not partnering this project, two patient organisations (British Lung Foundation and Longfonds – formerly Astma Fonds) are partners in this project. PROactive aims to develop, validate and use patient reported outcome (PRO) tools investigating aspects of everyday physical activity that are judged by patients living with chronic obstructive pulmonary disease (COPD) to be essential.

A better understanding of all relevant dimensions (amount, symptoms, distress, etc.) of physical (in)activity that are meaningful to patients will help to describe the patients' experience of COPD in a more insightful manner. Improvement in the PROs will offer new endpoints to be tested in clinical trials and to inform medicines labelling. Beyond clinical trials patients indicated the use of the tool may be important for self management purposes. PROactive is being developed with input from regulatory authorities and patient organisations. More importantly the items used in the tool have been developed based on patients’ interviews and their language.

The results of the research performed by the PROactive consortium will be of immediate importance to the 10% of elderly European citizens suffering from COPD. It will provide a means of assessing the impact of medication, rehabilitation or behaviour intervention by asking the patient how it has affected their everyday physical activity. The latter will allow bringing the effects to concrete and understandable benefits for patients. Currently the tool has been developed and is being validated. It will then be tested in a variety of studies dealing with medicines and other interventions (e.g. respiratory rehabilitation and behaviour). The input from patients has been and is still provided throughout the project via a dedicated advisory board (“Patient Input Platform”) and the internal “Ethics Board”. These boards tackle all ethical, patient safety and patient’s perspective issues, and should help identifying valorisation potential of the outcomes. Patients also provided main input during the development of the tool as a participant in the studies and via feedback rounds. They are also being involved in the next testing part via interviews. At different occasions study results have been and will be communicated to patients and public. The PROactive project is expected to deliver in 2014. More and actual information can be found on the PROactive website (http://www.proactivecopd.com) and on the IMI-JU website  (http://www.imi.europa.eu). Pim de Boer, Longfonds, The Netherlands