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Physical Activity as a Crucial Patient Reported Outcome in COPD

Objective

Physical activity (PA) is essential in maintaining optimal health in chronic diseases, including COPD.More physically active patients have less hospital admissions and better survival. Validated physicalactivity monitors have become available in recent years, and together with patient report of symptomsand distress of physical (in)activity, this may form a potent new Patient Reported Outcome (PRO) in COPD.In response to the IMI-call this consortium will develop and validate two PRO’s. In phase 1, items for
the PRO will be generated based on input from an updated literature survey, expert opinion and patients. One PRO investigates PA on a daily basis, using a user friendly interface. This allows investigating the impact of exacerbations and the dynamics of improvement after initiating treatment. A second PRO is used during clinical trial visits. A unique feature of the PRO’s is that they will include unobtrusive physical activity monitoring. Validity, reproducibility, responsiveness and minimally
clinically meaningful difference of the PRO’s will be investigated. The new PRO’s will be put in thecontext of other, more conventional outcomes. using path-analysis and structural equational modeling.Development will be in compliance to the guidelines of the FDA and in collaboration with EMEA.Iii phase 2 the PRO’s will be used in 3 large multi-center clinical trials. These trials will contribute tothe validity and health economic value of the PRO’s. They tackle contemporary questions in COPDcare, including pharmacotherapy, PA counseling and pulmonary rehabilitation.The consortium is well equipped to develop PRO’s. It includes academic centers with a solid reputationin COPD research, centers with expertise in epidemiology, experts in conducting systematic reviews,PRO-methodology and statistics. Patient associations are in the core of the consortium. A SME willdevelop patient material in various languages.

Call for proposal

IMI-JU-01-2008
See other projects for this call

Funding Scheme

JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)

Coordinator

CHIESI FARMACEUTICI SPA
Address
Via Palermo 26/A
43122 Parma
Italy
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Principal investigator
Mario Scuri (MD,PhD)
Administrative Contact
Roberta Montacchini (Mrs)

Participants (19)

KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 1 383 316
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Maria Vereeken (Mrs)
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
United Kingdom
Address
Great West Road 980
TW89GS Brentford
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Elaine Irving (Dr)
THE UNIVERSITY OF EDINBURGH
United Kingdom
EU contribution
€ 1 005 014
Address
Old College, South Bridge
EH8 9YL Edinburgh
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Angela Noble (Ms)
THORAX RESEARCH FOUNDATION
Greece
EU contribution
€ 779 688
Address
Ploutarhous
106 75 Kolonaki, Athens Greece
Administrative Contact
CHARALAMBOS ROUSSOS (PROFESSOR)
ROYAL BROMPTON AND HAREFIELD NATIONAL HEALTH SERVICE TRUST
United Kingdom
EU contribution
€ 1 076 742
Address
Sydney Street
SW3 6NP London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
George Karagiannis (Mr)
FUNDACIO INSTITUT MAR D INVESTIGACIONS MEDIQUES IMIM

Participation ended

Spain
EU contribution
€ 193 823
Address
Doctor Aiguader 88
08003 Barcelona
Activity type
Research Organisations
Administrative Contact
Carol Barnwell (Ms)
University of Zurich
Switzerland
EU contribution
€ 581 835
Address
Ramistrasse 71
8006 Zurich
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Johann Steurer (Prof)
ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
EU contribution
€ 606 270
Address
Hanzeplein 1
9713 GZ Groningen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jan J. Breeuwsma (mr)
Netherlands Asthma Foundation
Netherlands
EU contribution
€ 235 338
Address
Speelkamp
3831PE Leusden
Administrative Contact
Cisilla Molnar (-)
British Lung Foundation
United Kingdom
EU contribution
€ 66 090
Address
Goswell Road
EC1V 7ER London
Administrative Contact
Christine Lewis (Ms)
Choice Healthcare solutions Ltd
United Kingdom
EU contribution
€ 462 475
Address
Knowl Piece, Wilbury Way
SG4 0TY Hitchin, Hertfordshire
Administrative Contact
Andrew Bowman (Mr)
EUROPEAN RESPIRATORY SOCIETY
Switzerland
EU contribution
€ 103 044
Address
Avenue Sainte Luce 4
1003 Lausanne
Activity type
Other
Administrative Contact
Bill Werner (Mr)
PFIZER LIMITED

Participation ended

United Kingdom
Address
Ramsgate Road
CT13 9NJ Sandwich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Olga Krylova (Dr)
ALMIRALL SA
Spain
Address
General Mitre 151
08022 Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
BERGA PERE (Dr)
NOVARTIS PHARMA AG
Switzerland
Address
Lichtstrasse 35
4056 Basel
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Stephen Pearce (Dr)
ASTRAZENECA AB
Sweden
Address
Vastra Maelarhamnen
151 85 Sodertaelje
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Mathias Lyon (Mr)
UCB PHARMA SA
Belgium
Address
Allee De La Recherche 60
1070 Bruxelles
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Simon Dresse (Mr)
BOEHRINGER INGELHEIM INTERNATIONALGMBH
Germany
Address
Binger Strasse
55218 Ingelheim
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Marcus Kostka (Dr)
FUNDACIO CENTRE DE RECERCA EN EPIDEMIOLOGIA AMBIENTAL - CREAL
Spain
EU contribution
€ 273 962
Address
Calle Doctor Aiguader 88
08003 Barcelona
Activity type
Research Organisations
Administrative Contact
Anna Sillero (Ms)