Development and Validation of the GLORI-COPD Score

Active, not recruiting

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT04027296
• Lead Sponsor: University of Paris 5 - Rene Descartes

Brief 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

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 Timeline

• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-19
• Study Start: 2022-05-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-11-01
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 462

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy of the score	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

Secondary Outcome Measures

Name	Time	Method
COPD diagnosis	Baseline	FEV1/FVC \< 0.7
complications	6 and 12 months	-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)
COPD Assessment test (CAT)	baseline, 6 and 12 months	scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life
death	12 months
ADO index (Age, Dyspnea, Obstruction)	baseline, 6 and 12 months	evaluates mortality risk in copd patients from 0 to 14 (higher scores are linked woh higher mortality risk)
GOLD stage	baseline	COPD severity from A (less severe) to D (very severe)
Modified Medical Research Council Dyspnea scale score (mMRC)	baseline, 6 and 12 months	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

Trial Locations

Locations (1)

Université Paris Cité; 🇫🇷 Paris, France