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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04027296
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : February 7, 2020
Sponsor:
Collaborators:
Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Alexandre MALMARTEL, 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

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 920 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening of COPD Patients at Risk of Complications in General Practice:
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : February 2022

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



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Publications:
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Responsible Party: Alexandre MALMARTEL, Academic doctor of medicine, University of Paris 5 - Rene Descartes
ClinicalTrials.gov Identifier: NCT04027296    
Other Study ID Numbers: 2018-A03259-46
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive