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Completed

NCT Number: NCT04027296

Development and Validation of the GLORI-COPD Score

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Université Paris Cité

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. diagnostic accuracy of the score

    Time frame: 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 outcomes

  1. COPD diagnosis

    Time frame: Baseline

    FEV1/FVC < 0.7

  2. 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)

  3. death

    Time frame: 12 months

  4. 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

  5. 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

  6. 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)

  7. GOLD stage

    Time frame: baseline

    COPD severity from A (less severe) to D (very severe)

Sponsors and collaborators

Lead sponsor

University of Paris 5 - Rene Descartes

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

Registry information

Official study title

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

Acronym: GLORI-COPD

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2019
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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