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Completed

NCT Number: NCT01241526

The COPD Patient Management European Trial (COMET)

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier d Antibes Juans-les-pins, Antibes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disease management

Other
  • Individual, group and phone education sessions
  • Telephone supporter follow-up
  • LTOT monitoring

Other names: Living Well With COPD Disease Management Program

Usual site management

Other
  • Usual education as per site protocol
  • Usual follow-up as per site protocol
  • LTOT monitoring

Primary outcomes

  1. Number of unscheduled hospital days

    Time frame: up to 12 months

Secondary outcomes

  1. Number of hospital days due to severe COPD exacerbation

    Time frame: up to 12 months

  2. Safety parameters

    Time frame: up to 12 months

    Adverse Events (AEs)

  3. Medico-economic data

    Time frame: up to 12 months

    Cost estimation, Cost-effectiveness, Cost-utility.

  4. Health related quality of life

    Time frame: up to 12 months

  5. Use of health care services

    Time frame: up to 12 months

  6. Compliance to oxygen therapy

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Air Liquide Santé International

Industry

Collaborators

  • ITEC Services
  • Lincoln Medical and Mental Health Center

Registry information

Official study 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.

Acronym: COMET

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 16, 2010
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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