Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— COMETOfficial 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.
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.
Status | Completed |
Enrollment | 346 |
Est. completion date | October 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
France | 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 Pitié-Salpétrière | Paris | |
France | Hôpital Saint Louis | Paris | |
France | Groupe Hospitalier Saint Joseph | Paris Cedex 14 | |
France | Hôpital Civil de Strasbourg | Strasbourg | |
France | Hôpital Beauregard - CHR METZ | Thionville | |
France | Hôpital Sainte Musse | Toulon | |
Germany | Universitatklinikum | Aachen | |
Germany | Helios Hagen-Ambrock | Hagen | |
Germany | Thoraxklinik Heidelberg gGmbh | Heidelberg | |
Germany | Lungenklinik Hemer | Hemer | |
Germany | Marien Krankenhaus | Kassel | Hesse |
Germany | Fachkrankenhaus Kloster Grafschaft | Schmallenberg | |
Germany | Klinik für Pneumologie und Allergologie | Solingen | |
Germany | Universitätsklinikum Ulm, - Klinik Innere Medizin II | ULM | |
Italy | Azienda ULSS 22 - Ospedale di Bussolengo | Bussolengo | |
Italy | ASL Viterbo | Civita Castellana | |
Italy | Ospedale di Macerata | Macerata | |
Italy | Azienda Ospedaliera, "Ospedale San Carlo Borromeo" | Milan | |
Italy | "Azienda Ospedaliera Niguarda | Milano | |
Italy | Azienda ospedialiera Di DESIO Vimercate | Seregno | |
Spain | Hospital Universitario de Burgos | Burgos | |
Spain | Hospital San Pedro de Alcantara | Caceres | |
Spain | Hospital Gregorio Maranon | Madrid | |
Spain | Hospital La Princessa | Madrid | |
Spain | Hospital Ramon Y Cajal | Madrid | |
Spain | Hospital Universitario de Asturia | Oviedo | |
Spain | Hospital Arnau de Vilanova | Valencia |
Lead Sponsor | Collaborator |
---|---|
Air Liquide Santé International | ITEC Services, Lincoln Medical and Mental Health Center |
France, Germany, Italy, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of unscheduled hospital days | up to 12 months | No | |
Secondary | Number of hospital days due to severe COPD exacerbation | up to 12 months | No | |
Secondary | Safety parameters | Adverse Events (AEs) | up to 12 months | Yes |
Secondary | Medico-economic data | Cost estimation, Cost-effectiveness, Cost-utility. | up to 12 months | No |
Secondary | Health related quality of life | up to 12 months | No | |
Secondary | Use of health care services | up to 12 months | No | |
Secondary | Compliance to oxygen therapy | up to 12 months | No |
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