The COPD Patient Management European Trial (COMET)

Air Liquide

Status and phase

Completed

Phase 4

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Other: Usual site management

Other: Disease Management

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01241526

ALMED-07-C4-008

Details and patient eligibility

About

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.

Full 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.

Enrollment

346 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

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