Clinical trial NCT01241526: The COPD Patient Management European Trial (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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
COMET
Disease management
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
Collaborators: name: ITEC Services
name: Lincoln Medical and Mental Health Center
First posted: 2010-11-16
Enrollment: 346
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of unscheduled hospital days
timeFrame: up to 12 months
Secondary outcomes:
measure: Number of hospital days due to severe COPD exacerbation
timeFrame: up to 12 months
measure: Safety parameters
timeFrame: up to 12 months
measure: Medico-economic data
timeFrame: up to 12 months
measure: Health related quality of life
timeFrame: up to 12 months
measure: Use of health care services
timeFrame: up to 12 months
measure: Compliance to oxygen therapy
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Antibes
country: France
facility: Centre Hospitalier d Antibes Juans-les-pins
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar - Hôpital Pasteur
city: Grenoble
country: France
facility: CHU de Grenoble
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord
city: Metz
country: France
facility: Hôpital MERCY
city: Paris Cedex 14
country: France
facility: Groupe Hospitalier Saint Joseph
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpétrière
city: Strasbourg
country: France
facility: Hôpital Civil de Strasbourg
city: Thionville
country: France
facility: Hôpital Beauregard - CHR METZ
city: Toulon
country: France
facility: Hôpital Sainte Musse
city: Kassel
country: Germany
facility: Marien Krankenhaus
state: Hesse
city: Aachen
country: Germany
facility: Universitatklinikum
city: Hagen
country: Germany
facility: Helios Hagen-Ambrock
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbh
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Schmallenberg
country: Germany
facility: Fachkrankenhaus Kloster Grafschaft
city: Solingen
country: Germany
facility: Klinik für Pneumologie und Allergologie
city: ULM
country: Germany
facility: Universitätsklinikum Ulm, - Klinik Innere Medizin II
city: Bussolengo
country: Italy
facility: Azienda ULSS 22 - Ospedale di Bussolengo
city: Civita Castellana
country: Italy
facility: ASL Viterbo
city: Macerata
country: Italy
facility: Ospedale di Macerata
city: Milano
country: Italy
facility: "Azienda Ospedaliera Niguarda
city: Milan
country: Italy
facility: Azienda Ospedaliera, "Ospedale San Carlo Borromeo"
city: Seregno
country: Italy
facility: Azienda ospedialiera Di DESIO Vimercate
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Madrid
country: Spain
facility: Hospital La Princessa
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Ramon Y Cajal
city: Oviedo
country: Spain
facility: Hospital Universitario de Asturia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
affiliation: Hopital Civil de Strasbourg - France
name: Romain KESSLER, MD
role: STUDY_CHAIR
References:
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.
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.