The COPD Patient Management European Trial (COMET)

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT01241526
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Primary Completion: 2015-02
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 346

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of unscheduled hospital days	up to 12 months

Secondary Outcome Measures

Name	Time	Method
Safety parameters	up to 12 months	Adverse Events (AEs)
Medico-economic data	up to 12 months	Cost estimation, Cost-effectiveness, Cost-utility.
Health related quality of life	up to 12 months
Use of health care services	up to 12 months
Compliance to oxygen therapy	up to 12 months
Number of hospital days due to severe COPD exacerbation	up to 12 months

Trial Locations

Locations (34)

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 Saint Joseph; 🇫🇷 Paris Cedex 14, France

Hôpital Saint Louis; 🇫🇷 Paris, France

Groupe Hospitalier Pitié-Salpétrière; 🇫🇷 Paris, France

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