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.

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.

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.

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