Pulmonary Disease, Chronic ObstructiveGLORI-COPDNCT04027296
Development and Validation of the GLORI-COPD Score
An observational study of Pulmonary Disease, Chronic Obstructive, run by University of Paris 5 - Rene Descartes at 1 site in France.
Trial summary
The objective of this study is to evaluate the diagnostic accuracy of the GLORI-COPD score in ambulatory care, to enable the screening of COPD patients at risk of complications, requiring early management Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 462 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2022to 1 Nov 2025
- Phase
- Observational
- 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
Study population: The study population will be any patient consulting a general practitioner over 35 years of age with smoking (active or weaned) in excess of 10 pack-years.
Who may be able to join
- age ≥ 35 yo
- smoker or former smoker ≥ 10 Pack Years
Who cannot join
- Patients who have already been diagnosed with COPD by spirometry,
- have a contraindication to spirometry,
- have an estimated life expectancy of less than 5 years
- are under protective measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening of COPD Patients at Risk of Complications in General Practice:
The objective of this study is to evaluate the diagnostic accuracy of the GLORI-COPD score in ambulatory care, to enable the screening of COPD patients at risk of complications, requiring early management
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a chronic disease with a high prevalence in France, but which remains under-diagnosed due to the trivialization of symptoms and difficulty in accessing diagnostic investigations. It is associated with other co-morbidities, with an impact on the occurrence of complications and quality of life. Early management of the most severe patients would allow better control of these risks of complications. Our objective is to better identify patients with COPD at risk of complications in general practice, taking into account the totality of the patient, to improve their management.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- 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.
| Study group | Role | What they receive |
|---|---|---|
| suspected COPD | Patients aged ≥ 35yo and ≥10Pack.Year |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy of the score
The diagnostic accuracy of the score will be evaluated to determine the risk of pulmonary complication in patients with COPD.
Sensitivity, specificity, positive predictive value and negative predictive value
Measured: 12 months
Secondary outcomes (7)
COPD diagnosis
FEV1/FVC < 0.7
Measured: Baseline
complications
-Composite criterion: Occurrence of a low respiratory infection (bronchitis, COPD exacerbation, lung infection or pneumonitis) in an outpatient or inpatient setting or following a death (1st event)
Measured: 6 and 12 months
death
Measured: 12 months
Modified Medical Research Council Dyspnea scale score (mMRC)
evaluating dyspnea from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing
Measured: baseline, 6 and 12 months
COPD Assessment test (CAT)
scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life
Measured: baseline, 6 and 12 months
ADO index (Age, Dyspnea, Obstruction)
evaluates mortality risk in copd patients from 0 to 14 (higher scores are linked woh higher mortality risk)
Measured: baseline, 6 and 12 months
GOLD stage
COPD severity from A (less severe) to D (very severe)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 May 2022
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Paris 5 - Rene Descartes
- Sponsor type
- University, hospital or other
- Collaborators
- Recherche Clinique Paris Descartes Necker Cochin Sainte Anne, Assistance Publique - Hôpitaux de Paris
- Responsible party
- Principal investigator, Alexandre MALMARTEL, University of Paris 5 - Rene Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027296
- Sponsor's protocol ID
- 2018-A03259-46
- Acronym
- GLORI-COPD
- Status last verified
- Apr 2026
- First submitted
- 18 Jul 2019
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malmartel A, Eap D, Ghasarossian C. [Spotting the GLObalRIsk of severe outcomes in undiagnosed COPD patients (GLORI-COPD)]. Rev Mal Respir. 2018 Mar;35(3):347-352. doi: 10.1016/j.rmr.2017.10.663. Epub 2018 Mar 27. French.
PubMed 29602483
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of COPD Patients at Risk of Complications in General Practice:
- ClinicalTrials.gov ID
- NCT04027296
- Acronym / sponsor ID
- GLORI-COPD / 2018-A03259-46
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- University of Paris 5 - Rene DescartesUniversity, hospital or other
- Collaborators
- Recherche Clinique Paris Descartes Necker Cochin Sainte Anne, Assistance Publique - Hôpitaux de Paris
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 19 Jul 2019 (actual)
- 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 objective of this study is to evaluate the diagnostic accuracy of the GLORI-COPD score in ambulatory care, to enable the screening of COPD patients at risk of complications, requiring early management
Detailed description
Chronic obstructive pulmonary disease (COPD) is a chronic disease with a high prevalence in France, but which remains under-diagnosed due to the trivialization of symptoms and difficulty in accessing diagnostic investigations. It is associated with other co-morbidities, with an impact on the occurrence of complications and quality of life. Early management of the most severe patients would allow better control of these risks of complications. Our objective is to better identify patients with COPD at risk of complications in general practice, taking into account the totality of the patient, to improve their management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suspected COPD | – | –Patients aged ≥ 35yo and ≥10Pack.Year |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be any patient consulting a general practitioner over 35 years of age with smoking (active or weaned) in excess of 10 pack-years.
Key inclusion criteria (2 listed)
- age ≥ 35 yo
- smoker or former smoker ≥ 10 Pack Years
Key exclusion criteria (4 listed)
- Patients who have already been diagnosed with COPD by spirometry,
- have a contraindication to spirometry,
- have an estimated life expectancy of less than 5 years
- are under protective measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diagnostic accuracy of the score
Time frame: 12 months
The diagnostic accuracy of the score will be evaluated to determine the risk of pulmonary complication in patients with COPD. Sensitivity, specificity, positive predictive value and negative predictive value
7 secondary outcomes
COPD diagnosis
Time frame: Baseline
complications
Time frame: 6 and 12 months
death
Time frame: 12 months
Modified Medical Research Council Dyspnea scale score (mMRC)
Time frame: baseline, 6 and 12 months
COPD Assessment test (CAT)
Time frame: baseline, 6 and 12 months
ADO index (Age, Dyspnea, Obstruction)
Time frame: baseline, 6 and 12 months
GOLD stage
Time frame: baseline
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 29 Apr 2026.
- Background: PubMed 29602483Malmartel A, Eap D, Ghasarossian C. [Spotting the GLObalRIsk of severe outcomes in undiagnosed COPD patients (GLORI-COPD)]. Rev Mal Respir. 2018 Mar;35(3):347-352. doi: 10.1016/j.rmr.2017.10.663. Epub 2018 Mar 27. French.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by University of Paris 5 - Rene Descartes at 1 site in France.
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 2 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
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?
diagnostic accuracy of the score (time frame: 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 NCT04027296, which also lists 1 linked publication.
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 29 Apr 2026.