Development and Validation of the GLORI-COPD Score

Overview

The objective is to develop and validate a score: the GLORI COPD, to screen COPD patients at risk of complications, requiring early management, in general practice

Full Title of Study: “Screening of COPD Patients at Risk of Complications in General Practice:”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2021

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.

Arms, Groups and Cohorts

  • COPD
    • Patients with FEV1/FVC ratio < 0.7
  • not COPD
    • Patients with FEV1/FVC ratio > 0.7

Clinical Trial Outcome Measures

Primary Measures

  • pulmonary infection
    • Time Frame: 12 montshs
    • the occurrence, at 12 months, of a low respiratory infection, which is managed either on an outpatient basis or during hospitalization.

Secondary Measures

  • COPD diagnosis
    • Time Frame: Baseline
    • FEV1/FVC < 0.7
  • complications
    • Time Frame: 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)
  • death
    • Time Frame: 12 months
  • Modified Medical Research Council Dyspnea scale score (mMRC)
    • Time Frame: 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
  • COPD Assessment test (CAT)
    • Time Frame: baseline, 6 and 12 months
    • scores from 0-40. Higher scores denote a more severe impact of COPD on a patient’s life
  • ADO index (Age, Dyspnea, Obstruction)
    • Time Frame: 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
    • Time Frame: baseline
    • COPD severity from A (less severe) to D (very severe)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Paris 5 – Rene Descartes
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alexandre MALMARTEL, Academic doctor of medicine – University of Paris 5 – Rene Descartes

References

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.

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