Chronic Obstructive Pulmonary Disease (COPD)Phase 4COMETNCT01241526
The COPD Patient Management European Trial (COMET)
A Phase 4 study testing Disease Management and Usual site management in people with Chronic Obstructive Pulmonary Disease (COPD), run by Air Liquide Santé International at 34 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Disease Management and Usual site management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 34 sitesin 4 countries
- Study dates
- Sep 2010to Oct 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- LTOT for another reason than COPD
- Severe concomitant disorder associated with a limited probability of survival (< 6 months)
- Tracheostomy
- Long term oral corticosteroids therapy
Trial locations and contacts
34 sites in 4 countries.
34 sites in 4 countries
France13 sites
Centre Hospitalier d Antibes Juans-les-pins
Antibes, 06606
Hôpitaux Civils de Colmar - Hôpital Pasteur
Colmar, 68024
CHU de Grenoble
Grenoble, 38043
Centre Hospitalier du Mans
Le Mans, 72037
Hôpital de la Croix Rousse
Lyon, 69317
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, 13015
Hôpital MERCY
Metz, 57085
Hôpital Saint Louis
Paris, 75010
Groupe Hospitalier Pitié-Salpétrière
Paris, 75013
Groupe Hospitalier Saint Joseph
Paris, 75674
Hôpital Civil de Strasbourg
Strasbourg, 67098
Hôpital Beauregard - CHR METZ
Thionville, 57100
Hôpital Sainte Musse
Toulon, 83100
Germany8 sites
Universitatklinikum
Aachen, 52074
Helios Hagen-Ambrock
Hagen, 58091
Thoraxklinik Heidelberg gGmbh
Heidelberg, 69126
Lungenklinik Hemer
Hemer, 58675
Marien Krankenhaus
Kassel, Hesse, 34001
Fachkrankenhaus Kloster Grafschaft
Schmallenberg, 57392
Klinik für Pneumologie und Allergologie
Solingen, 42699
Universitätsklinikum Ulm, - Klinik Innere Medizin II
Ulm, 89081
Spain7 sites
Hospital Universitario de Burgos
Burgos, 09006
Hospital San Pedro de Alcantara
Cáceres, 10001
Hospital La Princessa
Madrid, Madrid, 28006
Hospital Gregorio Maranon
Madrid, Madrid, 28007
Hospital Ramon Y Cajal
Madrid, Madrid, 28034
Hospital Universitario de Asturia
Oviedo, 33006
Hospital Arnau de Vilanova
Valencia, 46015
Italy6 sites
Azienda ULSS 22 - Ospedale di Bussolengo
Bussolengo, 37012
ASL Viterbo
Civita Castellana, 01033
Azienda Ospedaliera, "Ospedale San Carlo Borromeo"
Milan, 20153
"Azienda Ospedaliera Niguarda
Milan, 20162
Ospedale di Macerata
Province of Macerata
Azienda ospedialiera Di DESIO Vimercate
Seregno, 20831
About this study
Official 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.
Read the 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.
- Being tested
- Disease Management, Usual site management
- Keywords
- COPD, COMET, Disease management
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease ManagementOther
Also called Living Well With COPD Disease Management Program
- Individual, group and phone education sessions
- Telephone supporter follow-up
- LTOT monitoring
Usual site managementOther
- Usual education as per site protocol
- Usual follow-up as per site protocol
- LTOT monitoring
| Study group | Role | What they receive |
|---|---|---|
| Disease management program | Experimental | Not described Receives: Other: Disease Management |
| Usual site management | Active comparator | Not described Receives: Other: Usual site management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of unscheduled hospital days
Measured: up to 12 months
Secondary outcomes (6)
Number of hospital days due to severe COPD exacerbation
Measured: up to 12 months
Safety parameters
Adverse Events (AEs)
Measured: up to 12 months
Medico-economic data
Cost estimation, Cost-effectiveness, Cost-utility.
Measured: up to 12 months
Health related quality of life
Measured: up to 12 months
Use of health care services
Measured: up to 12 months
Compliance to oxygen therapy
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionFeb 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ITEC Services, Lincoln Medical and Mental Health Center
- Responsible party
- Sponsor
- Investigators
- Romain KESSLER, MD, Study chair, Hopital Civil de Strasbourg - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241526
- Sponsor's protocol ID
- ALMED-07-C4-008
- Acronym
- COMET
- Status last verified
- Jan 2016
- First submitted
- 9 Nov 2010
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.
PubMed 34495549Kessler R, Casan-Clara P, Koehler D, Tognella S, Viejo JL, Dal Negro RW, Diaz-Lobato S, Reissig K, Rodriguez Gonzalez-Moro JM, Devouassoux G, Chavaillon JM, Botrus P, Arnal JM, Ancochea J, Bergeron-Lafaurie A, De Abajo C, Randerath WJ, Bastian A, Cornelissen CG, Nilius G, Texereau JB, Bourbeau J. COMET: a multicomponent home-based disease-management programme versus routine care in severe COPD. Eur Respir J. 2018 Jan 11;51(1):1701612. doi: 10.1183/13993003.01612-2017. Print 2018 Jan.
PubMed 29326333
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT01241526
- Acronym / sponsor ID
- COMET / ALMED-07-C4-008
- Keywords
- COPD, COMET, Disease management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Collaborators
- ITEC Services, Lincoln Medical and Mental Health Center
- Study start
- Sep 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease management program | Experimental | Other: Disease Management |
| Usual site management | Active comparator | Other: Usual site management |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- LTOT for another reason than COPD
- Severe concomitant disorder associated with a limited probability of survival (< 6 months)
- Tracheostomy
- Long term oral corticosteroids therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disease ManagementAlso: Living Well With COPD Disease Management Program* Individual, group and phone education sessions * Telephone supporter follow-up * LTOT monitoring | Other | Disease management program |
| Usual site management* Usual education as per site protocol * Usual follow-up as per site protocol * LTOT monitoring | Other | Usual site management |
Primary outcome
Number of unscheduled hospital days
Time frame: up to 12 months
6 secondary outcomes
Number of hospital days due to severe COPD exacerbation
Time frame: up to 12 months
Safety parameters
Time frame: up to 12 months
Medico-economic data
Time frame: up to 12 months
Health related quality of life
Time frame: up to 12 months
Use of health care services
Time frame: up to 12 months
Compliance to oxygen therapy
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Derived from this study: PubMed 34495549Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.
- Derived from this study: PubMed 29326333Kessler R, Casan-Clara P, Koehler D, Tognella S, Viejo JL, Dal Negro RW, Diaz-Lobato S, Reissig K, Rodriguez Gonzalez-Moro JM, Devouassoux G, Chavaillon JM, Botrus P, Arnal JM, Ancochea J, Bergeron-Lafaurie A, De Abajo C, Randerath WJ, Bastian A, Cornelissen CG, Nilius G, Texereau JB, Bourbeau J. COMET: a multicomponent home-based disease-management programme versus routine care in severe COPD. Eur Respir J. 2018 Jan 11;51(1):1701612. doi: 10.1183/13993003.01612-2017. Print 2018 Jan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain KESSLER, MD study chair
Hopital Civil de Strasbourg - France
34 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Disease Management and Usual site management in people with Chronic Obstructive Pulmonary Disease (COPD), run by Air Liquide Santé International at 34 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in France, Germany, Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of unscheduled hospital days (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01241526, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.