Validation of the Concept of Control of COPD in Clinical Practice

Lead Investigator:
Marc Miravitlles, Pneumology Department, Vall d’ Hebron University Hospital, Barcelona, Spain

Study Team:
David Price: Professor of Primary Care Respiratory Medicine, University of Aberdeen, Aberdeen, UK; Owner of Optimum Patient Care Ltd and Chairman of the Respiratory Effectiveness Group
Dermot Ryan: Honorary Fellow at the University of Edinburgh; Consultant at Optimum Patient Care Ltd, Cambridge, UK
Alberto Papi: S. Anna University Hospital, Ferrara, Italy
Nicolas Roche: University of Paris Descartes, Paris, France
Richard Costello: Royal College of Surgeons, Dublin, Irealnd
Juan José Soler-Cataluña: Pneumology Department, Hospital Arnau de Vilanova, Valencia, Spain and CIBER de Enfermedades Respiratorias (CIBERES)
Faisal Yunus: Department of Pulmonology and Respiratory Medicine, Universitas Indonesia (FMUI), Jakarta, Indonesia
Bernardino Alcazar Navarrete: Respiratory Department, Hospital de Alta Resolucion, Granada, Spain
David Halpin: Department of Respiratory Medicine, Royal Devon & Exeter Hospital, Exeter
Helgo Magnussen: Pulmonary Research Institute at Lung Clinic Grosshansdorf, Germany
Akio Niimi: Department of Respiratory Medicine, Kyoto University Graduate School of Medicine
Alison Chisholm: Chief Scientific Officer of the Respiratory Effectiveness Group, Cambridge, UK

Status: Active

Support:

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The concept of control has been extensively developed in asthma but little-explored in COPD. Recently, however, Soler-Cataluña et al proposed a new definition/concept of control for COPD. The concept aims to help describe the current clinical “situation” of the patient and to provide a tool that will help guide optimum treatment approaches for patients with COPD.

The definition has two components: (i) COPD impact and (ii) COPD stability. “Impact” is a cross-sectional concept that evaluates the clinical status of a patient. It is static assessment corresponding to a specific moment and can be assessed by questionnaires (i.e. the COPD Assessment Test [CAT] or the Clinical COPD Questionnaire [CCQ]) or evaluated based on a patient’s degree of dyspnea, use of rescue medication, level of physical activity and sputum colour. The temporal evolution of this impact (i.e. COPD stability) is a dynamic term. “Stability” is a longitudinal concept that requires the absence of exacerbations and deterioration in the aforementioned variables or in CAT or CCQ scores. Hence, control is defined as a condition that has both low impact (adjusted for severity) and stability (6).

Having proposed the concept of control in COPD, it is now important to establish whether the it has clinical validity and utility, specifically in terms of predicting outcomes and guiding on-going COPD management (and/or whether the measure may benefit from further refinement).

A multi-centre prospective trial is planned. In the interim, this study proposes a database pilot validation of the concept, which can then inform (but also be further validated by) the intended prospective study.

The aims of the proposed study are to:
(i) Characterise COPD patients treated in UK routine primary care in terms of their COPD control; and to,
(ii) Evaluate the clinical implications of control status.

Documents and Publications

  • Protocol
  • Abstracts
  • Presentations
  • Final Publications
  • Additional Material