The COPD Patient Management European Trial (COMET)

Chronic Obstructive Pulmonary Disease (COPD) Clinical 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241526
• Other study ID #: ALMED-07-C4-008
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2010
• Last updated: January 13, 2016
• Start date: September 2010
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: October 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Disease Management
Individual, group and phone education sessions Telephone supporter follow-up LTOT monitoring
• Usual site management
Usual education as per site protocol Usual follow-up as per site protocol LTOT monitoring

Locations

Country	Name	City	State
France	Centre Hospitalier d Antibes Juans-les-pins	Antibes
France	Hôpitaux Civils de Colmar - Hôpital Pasteur	Colmar
France	CHU de Grenoble	Grenoble
France	Centre Hospitalier du Mans	Le Mans
France	Hôpital de la Croix Rousse	Lyon
France	Assistance Publique Hôpitaux de Marseille - Hôpital Nord	Marseille
France	Hôpital MERCY	Metz
France	Groupe Hospitalier Pitié-Salpétrière	Paris
France	Hôpital Saint Louis	Paris
France	Groupe Hospitalier Saint Joseph	Paris Cedex 14
France	Hôpital Civil de Strasbourg	Strasbourg
France	Hôpital Beauregard - CHR METZ	Thionville
France	Hôpital Sainte Musse	Toulon
Germany	Universitatklinikum	Aachen
Germany	Helios Hagen-Ambrock	Hagen
Germany	Thoraxklinik Heidelberg gGmbh	Heidelberg
Germany	Lungenklinik Hemer	Hemer
Germany	Marien Krankenhaus	Kassel	Hesse
Germany	Fachkrankenhaus Kloster Grafschaft	Schmallenberg
Germany	Klinik für Pneumologie und Allergologie	Solingen
Germany	Universitätsklinikum Ulm, - Klinik Innere Medizin II	ULM
Italy	Azienda ULSS 22 - Ospedale di Bussolengo	Bussolengo
Italy	ASL Viterbo	Civita Castellana
Italy	Ospedale di Macerata	Macerata
Italy	Azienda Ospedaliera, "Ospedale San Carlo Borromeo"	Milan
Italy	"Azienda Ospedaliera Niguarda	Milano
Italy	Azienda ospedialiera Di DESIO Vimercate	Seregno
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital San Pedro de Alcantara	Caceres
Spain	Hospital Gregorio Maranon	Madrid
Spain	Hospital La Princessa	Madrid
Spain	Hospital Ramon Y Cajal	Madrid
Spain	Hospital Universitario de Asturia	Oviedo
Spain	Hospital Arnau de Vilanova	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
Air Liquide Santé International	ITEC Services, Lincoln Medical and Mental Health Center

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of unscheduled hospital days		up to 12 months	No
Secondary	Number of hospital days due to severe COPD exacerbation		up to 12 months	No
Secondary	Safety parameters	Adverse Events (AEs)	up to 12 months	Yes
Secondary	Medico-economic data	Cost estimation, Cost-effectiveness, Cost-utility.	up to 12 months	No
Secondary	Health related quality of life		up to 12 months	No
Secondary	Use of health care services		up to 12 months	No
Secondary	Compliance to oxygen therapy		up to 12 months	No