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The COPD Patient Management European Trial (COMET)

This study is currently recruiting participants.
Verified May 2013 by Air Liquide Santé International
Sponsor:
Collaborators:
ITEC Services
Lincoln
Information provided by (Responsible Party):
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT01241526
First received: November 9, 2010
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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: November 2014
Estimated Primary Completion Date: November 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241526

Contacts
Contact: Joelle TEXEREAU, MD +33 1 39 07 65 18 joelle.texereau@airliquide.com

Locations
France
Centre Hospitalier d'Antibes Juans-les-pins Recruiting
Antibes, France, 06606
Contact: Jean-Michel CHAVAILLON, MD     04 97 24 77 27     jean-michel.chavaillon@ch-antibes.fr    
Principal Investigator: Jean-Michel CHAVAILLON, MD            
Hôpitaux Civils de Colmar - Hôpital Pasteur Active, not recruiting
Colmar, France, 68024
CHU de Grenoble Recruiting
Grenoble, France, 38043
Contact: Jean-Louis PEPIN, MD     04 76 76 87 32     jpepin@chu-grenoble.fr    
Principal Investigator: Jean-louis PEPIN, MD            
Centre Hospitalier de Lagny - Marne la Vallée Withdrawn
Lagny, France, 77405
Centre Hospitalier du Mans Recruiting
Le Mans, France, 72037
Contact: F. GOUPIL, MD     +33243432450     fgoupil@ch-lemans.fr    
Principal Investigator: F GOUPIL, MD            
Hôpital de la Croix Rousse Recruiting
Lyon, France, 69317
Contact: Gilles DEVOUASSOUX, MD     +33426732947     gilles.devouassoux@chu-lyon.fr    
Principal Investigator: Gilles DEVOUASSOUX, MD            
Assistance Publique Hôpitaux de Marseille - Hôpital Nord Recruiting
Marseille, France, 13015
Contact: Denis-André CHARPIN, MD     04 91 96 86 31     denis-andre.charpin@ap-hm.fr    
Principal Investigator: Denis-andré CHARPIN, MD            
Hôpital MERCY Recruiting
Metz, France, 57085
Contact: Elena VOICU, MD     +33387557778     e.voicu@chr-metz-thionville.fr    
Principal Investigator: Elena VOICU, MD            
CHI Le Raincy-Montfermeil Withdrawn
Montfermeil, France, 93370
Hôpital Saint Louis Recruiting
Paris, France, 75010
Contact: Anne BERGERON, MD     01 42 49 41 66     anne.bergeron-lafaurie@sls.aphp.fr    
Principal Investigator: Anne BERGERON, MD            
Groupe Hospitalier Pitié-Salpétrière Recruiting
Paris, France, 75013
Contact: Thomas SIMILOWSKI, MD     01 42 16 77 97     thomas.similowski@psl.aphp.fr    
Principal Investigator: Thomas SIMILOWSKI, MD            
Groupe Hospitalier Saint Joseph Recruiting
Paris Cedex 14, France, 75674
Contact: Sergio SALMERON, MD     01 44 12 78 74     ssalmeron@hpsj.fr    
Principal Investigator: Sergio SALMERON, MD            
Hôpital Civil de Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Romain KESSLER, MD     03 69 55 06 46     romain.kessler@chru-strasbourg.fr    
Principal Investigator: Romain KESSLER, MD            
Hôpital Beauregard - CHR METZ Recruiting
Thionville, France, 57100
Contact: Pierre BOTRUS, MD     +33382558384     p.botrus@chr-metz-thionville.fr    
Principal Investigator: Pierre BOTRUS, MD            
Hôpital Sainte Musse Recruiting
Toulon, France, 83100
Contact: Jean-Michel ARNAL, MD     +33494145890     jmarnal@free.fr    
Principal Investigator: Jean-Michel ARNAL, MD            
Germany
Universitatklinikum Recruiting
Aachen, Germany, 52074
Contact: Christian CORNELISSEN, MD     +49 (0) 0241-8035002     ccornelissen@ukaachen.de    
Principal Investigator: Christian CORNELISSEN, MD            
Helios Hagen-Ambrock Recruiting
Hagen, Germany, 58091
Contact: Georg NILIUS, MD     +49 (0) 2331-9742002     georg.nilius@helios-kliniken.de    
Principal Investigator: Georg NILIUS, MD            
Thoraxklinik Heidelberg gGmbh Recruiting
Heidelberg, Germany, 69126
Contact: Felix HERTH, MD     +4906221-3961200     Felix.Herth@thoraxklinik-heidelberg.de    
Principal Investigator: Felix HERTH, MD            
Lungenklinik Hemer Recruiting
Hemer, Germany, 58675
Contact: Michael WESTHOFF, MD     "0 23 72 / 90 80 (Zentrale)     michael.westhoff@lkhemer.de    
Principal Investigator: Michael WESTOFF, MD            
Stifftung Krankenhaus Bethanien für die Grafschaft Moers Withdrawn
Moers, Germany, 47441
Fachkrankenhaus Kloster Grafschaft Recruiting
Schmallenberg, Germany, 57392
Contact: Dieter KÖHLER, MD     + 49 (0) 2972 791 - 00     d.koehler@fkkg.de    
Principal Investigator: Dieter KOHLER, MD            
Klinik für Pneumologie und Allergologie Recruiting
Solingen, Germany, 42699
Contact: Winfried RANDERATH, MD     +490212/636001     randerath@klinik-bethanien.de    
Principal Investigator: Winfried RANDERATH, MD            
Universitätsklinikum Ulm, - Klinik Innere Medizin II Recruiting
ULM, Germany, 89081
Contact: Christian SCHUMANN, MD     '+49 (0) 0731-500-45055     Christian.Schumann@uniklinik-ulm.de    
Principal Investigator: Christian SCHUMANN, MD            
Italy
Azienda ULSS 22 - Ospedale di Bussolengo Recruiting
Bussolengo, Italy, 37012
Contact: Silvia TOGNELLA, MD     +393478899960     stognella@ulss22.ven.it    
Principal Investigator: Silvia TOGNELLA, MD            
AUSL di Cesena - Ospedale M. Bufalini Not yet recruiting
Cesena, Italy, 47023
Contact: Beniamino PRATICO, MD     +39 0547 / 352864     bpratico@ausl-cesena.emr.it    
Principal Investigator: Beniamino PRATICO, MD            
ASL Viterbo Not yet recruiting
Civita Castellana, Italy, 01033
Contact: Patrizia SCAVALLI, MD     +39 0761/59 22 11     fisiop.allerg.cc@asl.vt.it    
Principal Investigator: Patrizia SCAVALLI, MD            
Ospedale di Macerata Not yet recruiting
Macerata, Italy
Contact: Alberto TUBALDI, MD     +39 0733-2572314     atubaldi@asl9.marche.it    
Principal Investigator: Alberto TUBALDI, MD            
Azienda Ospedaliera, "Ospedale San Carlo Borromeo" Recruiting
Milan, Italy, 20153
Contact: Sandro AMADUCCI, MD         Amaducci.Sandro@sancarlo.mi.it    
Principal Investigator: Sandro AMADUCCI, MD            
"Azienda Ospedaliera Niguarda Not yet recruiting
Milano, Italy, 20162
Contact: Joyce ROLO, MD     +39 (0) 3282125239     joyce.rolo@ospedaleniguarda.it    
Principal Investigator: Joyce ROLO, MD            
Spain
Hospital Universitario de Burgos Recruiting
Burgos, Spain, 09006
Contact: Carlos DE ABAJO, MD     34678428078     cdeabajo@hotmail.com    
Principal Investigator: Carlos DE ABAJO, MD            
Hospital San Pedro de Alcantara Recruiting
Caceres, Spain, 10001
Contact: Juan Anotnio RIESCO, MD     927 621342     jrm4653@yahoo.es    
Principal Investigator: Juan Antonio RIESCO, MD            
Hospital de Mérida Withdrawn
Merida, Spain, 6800
Hospital Universitario de Asturia Recruiting
Oviedo, Spain, 33006
Contact: Pere CASAN, MD     0034 629384027     pcasan@ins.es    
Principal Investigator: Pere CASAN, MD            
Hosptital Arnau de Vilanova Recruiting
Valencia, Spain, 46015
Contact: Benjamin BROTONS, MD     650518779     neumo_arnau@gva.es    
Principal Investigator: Benjamin BROTONS, MD            
Sponsors and Collaborators
Air Liquide Santé International
ITEC Services
Lincoln
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: May 16, 2013
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 May 16, 2013