Validation of the Concept of COPD Control in Clinical Practice

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39103
• EU PAS number:
  EUPAS11656
• Study ID:
  39103
• Official title and acronym:
  Validation of the Concept of COPD Control in Clinical Practice
• DARWIN EU® study:
  No
• Study countries:
  Ireland

  Korea, Republic of

  Malta

  Poland

  Singapore

  Spain

  United Kingdom
• Study description:
  This is a 21-month pragmatic non-interventional trial comprising one baseline assessment and 4 follow-up visits. The primary aims of the study will be to evaluate the: 1). Levels of COPD control (vs poor COPD control) in an international cohort of routine care COPD patients, and 2). the clinical implications of control status.Secondary objectives of the study are to 1). Compare the utility of the COPD Control (as defined) as a tool to identify COPD impact and stability with the CAT and CCQ, 2). Evaluate the role of “adequate” (i.e. guideline-recommended) treatment prescribing on COPD control 3). Identify demographic and clinical characteristics associated with COPD control
• Study status:
  Finalised

Research institution and networks

Institutions

University Hospital Vall d’Hebron (HUVH)

Spain

Hospital de Alta Resolucion Granada, Spain, Royal College of Surgeons Dublin, Ireland, Hospital Universitari Vall d'Hebron Barcelona, Spain, Instituto de Investigacíon Sanitaria de Palma (IdISPa) Spain, Singapore General Hospital Singapore, Hospital of Laredo Spain, St. Mary's Hospital Seoul, Korea, Mater Dei Hospital Malta, Institute of Tuberculosis and Lung Disease Warsaw, Poland, Changi General Hospital (CGH) Singapore

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: 16/12/2015

Actual: 01/07/2015

Study start date

Planned: 11/08/2015

Actual: 27/08/2015

Date of final study report

Planned: 03/04/2018

Actual: 19/11/2019

Sources of funding

Other

Pharmaceutical company and other private sector 

More details on funding

Novartis, Respiratory Effectivness Group

Study protocol

Initial protocol

PROTOCOL_Validation of COPD Control_Clinical Study_REG-RES1503_update_161115

Regulatory

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