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Eur Respir J. 2018 Jan 11;51(1). pii: 1701612. doi: 10.1183/13993003.01612-2017. Print 2018 Jan.

COMET: a multicomponent home-based disease-management programme versus routine care in severe COPD.

Author information

1
Pneumologie, Fédération de Médecine Translationnelle de Strasbourg (FMTS), Université de Strasbourg, Strasbourg, France.
2
Asturias University Hospital, Oviedo, Spain.
3
Kloster Grafschaft Specialized Hospital, Schmallenberg, Germany.
4
Bussolengo General Hospital, Bussolengo, Italy.
5
Burgos University Hospital, Burgos, Spain.
6
Bussolengo Hospital, Bussolengo, Italy.
7
Ramón y Cajal University Hospital, Research Institute IRYCIS, Alcalá de Henares University, Madrid, Spain.
8
Principe de Asturias University Hospital, Madrid, Spain.
9
Croix Rousse Hospital, Lyon, France.
10
Antibes-Juan-les-Pins Hospital Center, Antibes, France.
11
Metz-Thionville Hospital Center, Thionville, France.
12
Sainte Musse Hospital, Toulon, France.
13
Pneumology Dept, La Princesa Hospital, Universidad Autónoma de Madrid, Madrid, Spain.
14
Pneumology Dept, Saint-Louis Hospital, Paris, France.
15
Dept of Pneumology, Bethanien C.V. Hospital, University of Cologne, Solingen, Germany.
16
St Mary's Hospital Kassel GmbH, Kassel, Germany.
17
Section for Pneumology, University Hospital Aachen, Aachen, Germany.
18
Dept of Pneumology, HELIOS Klinik Hagen-Ambrock, University of Witten/Herdecke, Hagen, Germany.
19
AP-HP, Dept of Respiratory Physiology, Cochin Hospital, René Descartes University, Paris, France.
20
Air Liquide Healthcare, Medical Research and Development, Jouy-en-Josas, France.
21
FRCP Respiratory Epidemiology and Clinical Research Unit, Research Institute of the McGill University Health Centre, Montréal, QC, Canada jean.bourbeau@mcgill.ca.

Abstract

The COPD Patient Management European Trial (COMET) investigated the efficacy and safety of a home-based COPD disease management intervention for severe COPD patients.The study was an international open-design clinical trial in COPD patients (forced expiratory volume in 1 s <50% of predicted value) randomised 1:1 to the disease management intervention or to the usual management practices at the study centre. The disease management intervention included a self-management programme, home telemonitoring, care coordination and medical management. The primary end-point was the number of unplanned all-cause hospitalisation days in the intention-to-treat (ITT) population. Secondary end-points included acute care hospitalisation days, BODE (body mass index, airflow obstruction, dyspnoea and exercise) index and exacerbations. Safety end-points included adverse events and deaths.For the 157 (disease management) and 162 (usual management) patients eligible for ITT analyses, all-cause hospitalisation days per year (mean±sd) were 17.4±35.4 and 22.6±41.8, respectively (mean difference -5.3, 95% CI -13.7 to -3.1; p=0.16). The disease management group had fewer per-protocol acute care hospitalisation days per year (p=0.047), a lower BODE index (p=0.01) and a lower mortality rate (1.9% versus 14.2%; p<0.001), with no difference in exacerbation frequency. Patient profiles and hospitalisation practices varied substantially across countries.The COMET disease management intervention did not significantly reduce unplanned all-cause hospitalisation days, but reduced acute care hospitalisation days and mortality in severe COPD patients.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01241526.

PMID:
29326333
DOI:
10.1183/13993003.01612-2017
[Indexed for MEDLINE]

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