Evaluation of COPD Control and its Clinical Implications in a Real-Life UK Primary Care Population

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26337
• EU PAS number:
  EUPAS10679
• Study ID:
  26337
• Official title and acronym:
  Evaluation of COPD Control and its Clinical Implications in a Real-Life UK Primary Care Population
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This objective of this study, proposed by Dr. Marc Miravitlles at the Vall d’ Hebron University Hospital (Barcelona, Spain), is to validate the concept of Control in COPD, as outlined in Soler- Cataluna et al. 2014. The protocol has been developed, and the study will be overseen by an international steering committee comprising members of REG’s COPD Control Working Group. The protocol will make use of the OPCRD and the study will serve as an important hypothesis-generating pilot for an international prospective trial commencing later in the year.
• Study status:
  Finalised

Research institutions and networks

Institutions

University Hospital Vall d’Hebron (HUVH)

Spain

Networks

Respiratory Effectiveness Group (REG)

Belgium

Denmark

France

Germany

Greece

Hungary

Italy

Netherlands

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 01/09/2015

Actual: 02/07/2015

Study start date

Planned: 01/09/2015

Actual: 01/08/2015

Date of final study report

Planned: 13/11/2015

Actual: 26/01/2016

Sources of funding

Other

More details on funding

Respiratory Effectiveness Group (REG)

Study protocol

Initial protocol

REG_COPD Control_UK Pilot Validation_300615_Protocol (1)

Regulatory

• Was the study required by a regulatory body?:
  Unknown
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable