The COPD Patient Management European Trial (COMET)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
ITEC Services
Lincoln Medical and Mental Health Center
Information provided by (Responsible Party):
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT01241526
First received: November 9, 2010
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:
  • Number of unscheduled hospital days [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of hospital days due to severe COPD exacerbation [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Safety parameters [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    Adverse Events (AEs)

  • Medico-economic data [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Cost estimation, Cost-effectiveness, Cost-utility.

  • Health related quality of life [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Use of health care services [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • Compliance to oxygen therapy [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 306
Study Start Date: September 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Disease management program Other: Disease Management
  • Individual, group and phone education sessions
  • Telephone supporter follow-up
  • LTOT monitoring
Other Name: 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

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.
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241526

Locations
France
Centre Hospitalier d'Antibes Juans-les-pins
Antibes, France, 06606
Hôpitaux Civils de Colmar - Hôpital Pasteur
Colmar, France, 68024
CHU de Grenoble
Grenoble, France, 38043
Centre Hospitalier du Mans
Le Mans, France, 72037
Hôpital de la Croix Rousse
Lyon, France, 69317
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, France, 13015
Hôpital MERCY
Metz, France, 57085
Groupe Hospitalier Pitié-Salpétrière
Paris, France, 75013
Hôpital Saint Louis
Paris, France, 75010
Groupe Hospitalier Saint Joseph
Paris Cedex 14, France, 75674
Hôpital Civil de Strasbourg
Strasbourg, France, 67098
Hôpital Beauregard - CHR METZ
Thionville, France, 57100
Hôpital Sainte Musse
Toulon, France, 83100
Germany
Universitatklinikum
Aachen, Germany, 52074
Helios Hagen-Ambrock
Hagen, Germany, 58091
Thoraxklinik Heidelberg gGmbh
Heidelberg, Germany, 69126
Lungenklinik Hemer
Hemer, Germany, 58675
Fachkrankenhaus Kloster Grafschaft
Schmallenberg, Germany, 57392
Klinik für Pneumologie und Allergologie
Solingen, Germany, 42699
Universitätsklinikum Ulm, - Klinik Innere Medizin II
ULM, Germany, 89081
Italy
Azienda ULSS 22 - Ospedale di Bussolengo
Bussolengo, Italy, 37012
AUSL di Cesena - Ospedale M. Bufalini
Cesena, Italy, 47023
ASL Viterbo
Civita Castellana, Italy, 01033
Ospedale di Macerata
Macerata, Italy
Azienda Ospedaliera, "Ospedale San Carlo Borromeo"
Milan, Italy, 20153
"Azienda Ospedaliera Niguarda
Milano, Italy, 20162
Spain
Hospital Universitario de Burgos
Burgos, Spain, 09006
Hospital San Pedro de Alcantara
Caceres, Spain, 10001
Hospital Universitario de Asturia
Oviedo, Spain, 33006
Hosptital Arnau de Vilanova
Valencia, Spain, 46015
Sponsors and Collaborators
Air Liquide Santé International
ITEC Services
Lincoln Medical and Mental Health Center
Investigators
Study Chair: Romain KESSLER, MD Hopital Civil de Strasbourg - France
  More Information

No publications provided

Responsible Party: Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT01241526     History of Changes
Other Study ID Numbers: ALMED-07-C4-008
Study First Received: November 9, 2010
Last Updated: February 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Air Liquide Santé International:
COPD
COMET
Disease management

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014