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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01241526
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : January 14, 2016
ITEC Services
Lincoln Medical and Mental Health Center
Information provided by (Responsible Party):
Air Liquide Santé International

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2010
Actual Primary Completion Date : February 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of unscheduled hospital days [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. Number of hospital days due to severe COPD exacerbation [ Time Frame: up to 12 months ]
  2. Safety parameters [ Time Frame: up to 12 months ]
    Adverse Events (AEs)

  3. Medico-economic data [ Time Frame: up to 12 months ]
    Cost estimation, Cost-effectiveness, Cost-utility.

  4. Health related quality of life [ Time Frame: up to 12 months ]
  5. Use of health care services [ Time Frame: up to 12 months ]
  6. Compliance to oxygen therapy [ Time Frame: up to 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01241526

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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 Saint Joseph
Paris Cedex 14, France, 75674
Hôpital Saint Louis
Paris, France, 75010
Groupe Hospitalier Pitié-Salpétrière
Paris, France, 75013
Hôpital Civil de Strasbourg
Strasbourg, France, 67098
Hôpital Beauregard - CHR METZ
Thionville, France, 57100
Hôpital Sainte Musse
Toulon, France, 83100
Marien Krankenhaus
Kassel, Hesse, Germany, 34001
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
Azienda ULSS 22 - Ospedale di Bussolengo
Bussolengo, Italy, 37012
ASL Viterbo
Civita Castellana, Italy, 01033
Ospedale di Macerata
Macerata, Italy
"Azienda Ospedaliera Niguarda
Milano, Italy, 20162
Azienda Ospedaliera, "Ospedale San Carlo Borromeo"
Milan, Italy, 20153
Azienda ospedialiera Di DESIO Vimercate
Seregno, Italy, 20831
Hospital Universitario de Burgos
Burgos, Spain, 09006
Hospital San Pedro de Alcantara
Caceres, Spain, 10001
Hospital La Princessa
Madrid, Spain, 28006
Hospital Gregorio Maranon
Madrid, Spain, 28007
Hospital Ramon Y Cajal
Madrid, Spain, 28034
Hospital Universitario de Asturia
Oviedo, Spain, 33006
Hospital Arnau de Vilanova
Valencia, Spain, 46015
Sponsors and Collaborators
Air Liquide Santé International
ITEC Services
Lincoln Medical and Mental Health Center
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Study Chair: Romain KESSLER, MD Hopital Civil de Strasbourg - France

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Air Liquide Santé International Identifier: NCT01241526     History of Changes
Other Study ID Numbers: ALMED-07-C4-008
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016

Keywords provided by Air Liquide Santé International:
Disease management

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