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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Disease Management
Usual site management
Sponsored by
Air Liquide Santé International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, COMET, Disease management

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier d Antibes Juans-les-pins
  • Hôpitaux Civils de Colmar - Hôpital Pasteur
  • CHU de Grenoble
  • Centre Hospitalier du Mans
  • Hôpital de la Croix Rousse
  • Assistance Publique Hôpitaux de Marseille - Hôpital Nord
  • Hôpital MERCY
  • Groupe Hospitalier Saint Joseph
  • Hôpital Saint Louis
  • Groupe Hospitalier Pitié-Salpétrière
  • Hôpital Civil de Strasbourg
  • Hôpital Beauregard - CHR METZ
  • Hôpital Sainte Musse
  • Marien Krankenhaus
  • Universitatklinikum
  • Helios Hagen-Ambrock
  • Thoraxklinik Heidelberg gGmbh
  • Lungenklinik Hemer
  • Fachkrankenhaus Kloster Grafschaft
  • Klinik für Pneumologie und Allergologie
  • Universitätsklinikum Ulm, - Klinik Innere Medizin II
  • Azienda ULSS 22 - Ospedale di Bussolengo
  • ASL Viterbo
  • Ospedale di Macerata
  • "Azienda Ospedaliera Niguarda
  • Azienda Ospedaliera, "Ospedale San Carlo Borromeo"
  • Azienda ospedialiera Di DESIO Vimercate
  • Hospital Universitario de Burgos
  • Hospital San Pedro de Alcantara
  • Hospital La Princessa
  • Hospital Gregorio Maranon
  • Hospital Ramon Y Cajal
  • Hospital Universitario de Asturia
  • Hospital Arnau de Vilanova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Disease management program

Usual site management

Arm Description

Outcomes

Primary Outcome Measures

Number of unscheduled hospital days

Secondary Outcome Measures

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

Full Information

First Posted
November 9, 2010
Last Updated
January 13, 2016
Sponsor
Air Liquide Santé International
Collaborators
ITEC Services, Lincoln Medical and Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT01241526
Brief Title
The COPD Patient Management European Trial (COMET)
Acronym
COMET
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide Santé International
Collaborators
ITEC Services, Lincoln Medical and Mental Health Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, COMET, Disease management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
346 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Disease management program
Arm Type
Experimental
Arm Title
Usual site management
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Disease Management
Other Intervention Name(s)
Living Well With COPD Disease Management Program
Intervention Description
Individual, group and phone education sessions Telephone supporter follow-up LTOT monitoring
Intervention Type
Other
Intervention Name(s)
Usual site management
Intervention Description
Usual education as per site protocol Usual follow-up as per site protocol LTOT monitoring
Primary Outcome Measure Information:
Title
Number of unscheduled hospital days
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Number of hospital days due to severe COPD exacerbation
Time Frame
up to 12 months
Title
Safety parameters
Description
Adverse Events (AEs)
Time Frame
up to 12 months
Title
Medico-economic data
Description
Cost estimation, Cost-effectiveness, Cost-utility.
Time Frame
up to 12 months
Title
Health related quality of life
Time Frame
up to 12 months
Title
Use of health care services
Time Frame
up to 12 months
Title
Compliance to oxygen therapy
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain KESSLER, MD
Organizational Affiliation
Hopital Civil de Strasbourg - France
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier d Antibes Juans-les-pins
City
Antibes
ZIP/Postal Code
06606
Country
France
Facility Name
Hôpitaux Civils de Colmar - Hôpital Pasteur
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier du Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Hôpital MERCY
City
Metz
ZIP/Postal Code
57085
Country
France
Facility Name
Groupe Hospitalier Saint Joseph
City
Paris Cedex 14
ZIP/Postal Code
75674
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Groupe Hospitalier Pitié-Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Civil de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hôpital Beauregard - CHR METZ
City
Thionville
ZIP/Postal Code
57100
Country
France
Facility Name
Hôpital Sainte Musse
City
Toulon
ZIP/Postal Code
83100
Country
France
Facility Name
Marien Krankenhaus
City
Kassel
State/Province
Hesse
ZIP/Postal Code
34001
Country
Germany
Facility Name
Universitatklinikum
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Helios Hagen-Ambrock
City
Hagen
ZIP/Postal Code
58091
Country
Germany
Facility Name
Thoraxklinik Heidelberg gGmbh
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Lungenklinik Hemer
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Name
Fachkrankenhaus Kloster Grafschaft
City
Schmallenberg
ZIP/Postal Code
57392
Country
Germany
Facility Name
Klinik für Pneumologie und Allergologie
City
Solingen
ZIP/Postal Code
42699
Country
Germany
Facility Name
Universitätsklinikum Ulm, - Klinik Innere Medizin II
City
ULM
ZIP/Postal Code
89081
Country
Germany
Facility Name
Azienda ULSS 22 - Ospedale di Bussolengo
City
Bussolengo
ZIP/Postal Code
37012
Country
Italy
Facility Name
ASL Viterbo
City
Civita Castellana
ZIP/Postal Code
01033
Country
Italy
Facility Name
Ospedale di Macerata
City
Macerata
Country
Italy
Facility Name
"Azienda Ospedaliera Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliera, "Ospedale San Carlo Borromeo"
City
Milan
ZIP/Postal Code
20153
Country
Italy
Facility Name
Azienda ospedialiera Di DESIO Vimercate
City
Seregno
ZIP/Postal Code
20831
Country
Italy
Facility Name
Hospital Universitario de Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Caceres
ZIP/Postal Code
10001
Country
Spain
Facility Name
Hospital La Princessa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario de Asturia
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
34495549
Citation
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.
Results Reference
derived
PubMed Identifier
29326333
Citation
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.
Results Reference
derived

Learn more about this trial

The COPD Patient Management European Trial (COMET)

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