The COPD Patient Management European Trial (COMET)

Sponsor

Air Liquide Santé International (Industry)

Overall Status

Completed

CT.gov ID

NCT01241526

Collaborator

ITEC Services (Other), Lincoln Medical and Mental Health Center (Other)

346

Enrollment

Locations

Arms

Duration (Months)

10.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Other: Disease Management Other: Usual site management	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

346 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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 Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of unscheduled hospital days [up to 12 months]

Secondary Outcome Measures

Number of hospital days due to severe COPD exacerbation [up to 12 months]
Safety parameters [up to 12 months]
Adverse Events (AEs)
Medico-economic data [up to 12 months]
Cost estimation, Cost-effectiveness, Cost-utility.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier d Antibes Juans-les-pins	Antibes		France	06606
2	Hôpitaux Civils de Colmar - Hôpital Pasteur	Colmar		France	68024
3	CHU de Grenoble	Grenoble		France	38043
4	Centre Hospitalier du Mans	Le Mans		France	72037
5	Hôpital de la Croix Rousse	Lyon		France	69317
6	Assistance Publique Hôpitaux de Marseille - Hôpital Nord	Marseille		France	13015
7	Hôpital MERCY	Metz		France	57085
8	Groupe Hospitalier Saint Joseph	Paris Cedex 14		France	75674
9	Hôpital Saint Louis	Paris		France	75010
10	Groupe Hospitalier Pitié-Salpétrière	Paris		France	75013
11	Hôpital Civil de Strasbourg	Strasbourg		France	67098
12	Hôpital Beauregard - CHR METZ	Thionville		France	57100
13	Hôpital Sainte Musse	Toulon		France	83100
14	Marien Krankenhaus	Kassel	Hesse	Germany	34001
15	Universitatklinikum	Aachen		Germany	52074
16	Helios Hagen-Ambrock	Hagen		Germany	58091
17	Thoraxklinik Heidelberg gGmbh	Heidelberg		Germany	69126
18	Lungenklinik Hemer	Hemer		Germany	58675
19	Fachkrankenhaus Kloster Grafschaft	Schmallenberg		Germany	57392
20	Klinik für Pneumologie und Allergologie	Solingen		Germany	42699
21	Universitätsklinikum Ulm, - Klinik Innere Medizin II	ULM		Germany	89081
22	Azienda ULSS 22 - Ospedale di Bussolengo	Bussolengo		Italy	37012
23	ASL Viterbo	Civita Castellana		Italy	01033
24	Ospedale di Macerata	Macerata		Italy
25	"Azienda Ospedaliera Niguarda	Milano		Italy	20162
26	Azienda Ospedaliera, "Ospedale San Carlo Borromeo"	Milan		Italy	20153
27	Azienda ospedialiera Di DESIO Vimercate	Seregno		Italy	20831
28	Hospital Universitario de Burgos	Burgos		Spain	09006
29	Hospital San Pedro de Alcantara	Caceres		Spain	10001
30	Hospital La Princessa	Madrid		Spain	28006
31	Hospital Gregorio Maranon	Madrid		Spain	28007
32	Hospital Ramon Y Cajal	Madrid		Spain	28034
33	Hospital Universitario de Asturia	Oviedo		Spain	33006
34	Hospital Arnau de Vilanova	Valencia		Spain	46015