Development and Validation of the GLORI-COPD Score (GLORI-COPD)

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

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive

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 Type: Observational
• Enrollment (Estimated): 920

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Recruiting
    • Université Paris Cité
    • Contact: MALMARTEL Alexandre; Phone Number: +331 44 41 23 58; Email: alexandre.malmartel@u-paris.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
suspected COPD; Patients aged ≥ 35yo and ≥10Pack.Year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
death		12 months
COPD diagnosis	FEV1/FVC < 0.7	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)	6 and 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	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	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)	baseline, 6 and 12 months
GOLD stage	COPD severity from A (less severe) to D (very severe)	baseline

Collaborators and Investigators

• Sponsor: University of Paris 5 - Rene Descartes
• Collaborators: Assistance Publique - Hôpitaux de Paris; Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2018-A03259-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No