Development and Validation of the GLORI-COPD Score

Pulmonary Disease, Chronic Obstructive Clinical Trial

— GLORI-COPD  

Official title:

Screening of COPD Patients at Risk of Complications in General Practice:

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04027296
• Other study ID #: 2018-A03259-46
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: November 2025

Study information

• Verified date: November 2023
• Source: University of Paris 5 - Rene Descartes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 920
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• age = 35 yo
• smoker or former smoker = 10 Pack Years

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
France	Université Paris Cité	Paris

Sponsors (3)

Lead Sponsor	Collaborator
University of Paris 5 - Rene Descartes	Assistance Publique - Hôpitaux de Paris, Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	COPD diagnosis	FEV1/FVC < 0.7	Baseline
Secondary	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)	6 and 12 months
Secondary	death		12 months
Secondary	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	baseline, 6 and 12 months
Secondary	COPD Assessment test (CAT)	scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life	baseline, 6 and 12 months
Secondary	ADO index (Age, Dyspnea, Obstruction)	evaluates mortality risk in copd patients from 0 to 14 (higher scores are linked woh higher mortality risk)	baseline, 6 and 12 months
Secondary	GOLD stage	COPD severity from A (less severe) to D (very severe)	baseline