NCT04027296

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
462

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
2.8 years until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

3.5 years

First QC Date

July 18, 2019

Last Update Submit

April 27, 2026

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • COPD diagnosis

    Baseline

  • complications

    6 and 12 months

  • death

    12 months

  • Modified Medical Research Council Dyspnea scale score (mMRC)

    baseline, 6 and 12 months

  • COPD Assessment test (CAT)

    baseline, 6 and 12 months

  • +2 more secondary outcomes

Study Arms (1)

suspected COPD

Patients aged ≥ 35yo and ≥10Pack.Year

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université Paris Cité

Paris, France

Location

Related 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.

    PMID: 29602483BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic doctor of medicine

Study Record Dates

First Submitted

July 18, 2019

First Posted

July 19, 2019

Study Start

May 1, 2022

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)