The COPD Patient Management European Trial (COMET) (COMET)

An International Phase IV Randomised Trial for Medical and Medico-economic Evaluations of Home-based Disease Management Program in Patients With Gold III/IV Chronic Obstructive Pulmonary Disease.

The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD.

By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Other: Disease Management; Other: Usual site management

Detailed Description

Primary objective: To evaluate a strategy of Chronic Obstructive Pulmonary Disease (COPD) management to reduce the number of hospital days in patients with severe Gold III/IV COPD: a Home-Based COPD Management Program versus usual patient education and follow-up.

Secondary objectives:

• To assess the clinical outcome and the health-related quality of life,
• To assess safety,
• To evaluate medico-economic impact.

• Study Type: Interventional
• Enrollment (Actual): 346
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Antibes, France, 06606
    • Centre Hospitalier d Antibes Juans-les-pins
  • Colmar, France, 68024
    • Hôpitaux Civils de Colmar - Hôpital Pasteur
  • Grenoble, France, 38043
    • CHU de Grenoble
  • Le Mans, France, 72037
    • Centre Hospitalier Du Mans
  • Lyon, France, 69317
    • Hopital de la Croix Rousse
  • Marseille, France, 13015
    • Assistance Publique Hôpitaux de Marseille - Hôpital Nord
  • Metz, France, 57085
    • Hopital Mercy
  • Paris, France, 75010
    • Hopital Saint Louis
  • Paris, France, 75013
    • Groupe Hospitalier Pitie-Salpetriere
  • Paris Cedex 14, France, 75674
    • Groupe Hospitalier Saint Joseph
  • Strasbourg, France, 67098
    • Hopital Civil de strasbourg
  • Thionville, France, 57100
    • Hôpital Beauregard - CHR METZ
  • Toulon, France, 83100
    • Hôpital Sainte Musse
• Germany
  • Aachen, Germany, 52074
    • Universitätklinikum
  • Hagen, Germany, 58091
    • Helios Hagen-Ambrock
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg gGmbH
  • Hemer, Germany, 58675
    • Lungenklinik Hemer
  • Schmallenberg, Germany, 57392
    • Fachkrankenhaus Kloster Grafschaft
  • Solingen, Germany, 42699
    • Klinik für Pneumologie und Allergologie
  • ULM, Germany, 89081
    • Universitätsklinikum Ulm, - Klinik Innere Medizin II
  • Hesse
    • Kassel, Hesse, Germany, 34001
      • Marien Krankenhaus
• Italy
  • Bussolengo, Italy, 37012
    • Azienda ULSS 22 - Ospedale di Bussolengo
  • Civita Castellana, Italy, 01033
    • ASL Viterbo
  • Macerata, Italy
    • Ospedale di Macerata
  • Milan, Italy, 20153
    • Azienda Ospedaliera, "Ospedale San Carlo Borromeo"
  • Milano, Italy, 20162
    • "Azienda Ospedaliera Niguarda
  • Seregno, Italy, 20831
    • Azienda ospedialiera Di DESIO Vimercate
• Spain
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos
  • Caceres, Spain, 10001
    • Hospital San Pedro de Alcántara
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
  • Madrid, Spain, 28007
    • Hospital Gregorio Marañon
  • Madrid, Spain, 28006
    • Hospital La Princessa
  • Oviedo, Spain, 33006
    • Hospital Universitario de Asturia
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Confirmed Gold III/IV COPD
• Current or ex-smoker with a smoking history ≥ 10 pack-years
• At least one COPD exacerbation leading to hospitalization in the year before selection.

Exclusion Criteria:

• LTOT for another reason than COPD
• Severe concomitant disorder associated with a limited probability of survival (< 6 months)
• Tracheostomy
• Long term oral corticosteroids therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Disease management program	Other: Disease Management; Individual, group and phone education sessions; Telephone supporter follow-up; LTOT monitoring; Other Names: Living Well With COPD Disease Management Program
Active Comparator: Usual site management	Other: Usual site management; Usual education as per site protocol; Usual follow-up as per site protocol; LTOT monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of unscheduled hospital days	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hospital days due to severe COPD exacerbation		up to 12 months
Safety parameters	Adverse Events (AEs)	up to 12 months
Medico-economic data	Cost estimation, Cost-effectiveness, Cost-utility.	up to 12 months
Health related quality of life		up to 12 months
Use of health care services		up to 12 months
Compliance to oxygen therapy		up to 12 months

Collaborators and Investigators

• Sponsor: Air Liquide Santé International
• Collaborators: ITEC Services; Lincoln Medical and Mental Health Center
• Investigators: Study Chair: Romain KESSLER, MD, Hopital Civil de Strasbourg - France

Publications and helpful links

General Publications

• Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.
• Kessler R, Casan-Clara P, Koehler D, Tognella S, Viejo JL, Dal Negro RW, Diaz-Lobato S, Reissig K, Rodriguez Gonzalez-Moro JM, Devouassoux G, Chavaillon JM, Botrus P, Arnal JM, Ancochea J, Bergeron-Lafaurie A, De Abajo C, Randerath WJ, Bastian A, Cornelissen CG, Nilius G, Texereau JB, Bourbeau J. COMET: a multicomponent home-based disease-management programme versus routine care in severe COPD. Eur Respir J. 2018 Jan 11;51(1):1701612. doi: 10.1183/13993003.01612-2017. Print 2018 Jan.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 9, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (Estimate): November 16, 2010

Study Record Updates

• Last Update Posted (Estimate): January 14, 2016
• Last Update Submitted That Met QC Criteria: January 13, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: COPD; Disease management; COMET
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ALMED-07-C4-008