NCT01241526

The COPD Patient Management European Trial (COMET)

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 346 (actual)
• Sponsor: Air Liquide Santé International · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
OTHER	Disease Management	* Individual, group and phone education sessions * Telephone supporter follow-up * LTOT monitoring
OTHER	Usual site management	* Usual education as per site protocol * Usual follow-up as per site protocol * LTOT monitoring

Timeline

• Start date: 2010-09-01
• Primary completion: 2015-02-01
• Completion: 2015-10-01
• First posted: 2010-11-16
• Last updated: 2016-01-14

Locations

34 sites across 4 countries: France, Germany, Italy, Spain