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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04005833
Other study ID # CHUBX 2017/43
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 19, 2019
Est. completion date June 1, 2023

Study information

Verified date June 2019
Source University Hospital, Bordeaux
Contact Emmanuel Prothon, MD
Phone +33662539394
Email emmanuel.prothon@u-bordeaux.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to estimate the association between blood fibrocytes measured during a suspected exacerbation and 3-year decline forced expiratory volume in one second (FEV1), in patients with Chronic obstructive pulmonary disease (COPD) in primary care, with a history of smoking, independently of the number of exacerbations and of tobacco or occupational exposure.


Description:

COPD is highly prevalent in primary care. It is associated with tobacco smoke or toxic occupational exposure. Some COPD patients will experience a faster decline in quality of life and lung function. There is currently no prognostic marker allowing to identify those patients at higher risk of fast lung function decline. Recent data suggest that fibrocytes are involved in COPD's physiopathology. A higher blood fibrocytes level during an acute exacerbation has been associated with higher mortality in COPD patients at a late stage of the disease. In mice, fibrocytes role in lung function decline has been demonstrated at an early stage. To date, association between blood fibrocytes during an exacerbation and lung function decline has not been evaluated at the early stage of COPD in humans.

This study aims to estimate the association between blood fibrocytes measured during a suspected exacerbation and 3-year decline in forced expiratory volume in one second (FEV1), in patients with COPD in primary care, with a history of smoking, independently of the number of exacerbations and of tobacco or occupational exposure.

In this study, blood fibrocytes during a suspected exacerbation will be measured at inclusion. The lung function (FEV1) will be assessed at follow-up visits at 2 months, 12 months and 36 months after inclusion. COPD-related health status and severity of dyspnea will be assessed with COPD Assessment test (CAT) and the modified Medical Research Council dyspnea scale (mMRC) at follow-up visits at 2 months, 12 months and 36 months after inclusion.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 230
Est. completion date June 1, 2023
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- man or woman aged more than 40 years old,

- with tobacco exposure of more than 20 pack-years,

- Presenting to a General Practitioner with a suspected mild or moderate COPD exacerbation according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (worsening of symptoms with the need for prescribing short acting bronchodilatators, antibiotics or oral corticosteroids)

- Informed consent given

- Affiliated to a social insurance scheme

Exclusion Criteria:

- Severe exacerbation of COPD according to GOLD guidelines (patient requires hospitalization or visits to the emergency room),

- More likely differential diagnosis than a COPD exacerbation, such as pneumonia, acute pulmonary oedema or other differential diagnosis,

- history of asthma, pulmonary fibrosis, primary pulmonary hypertension or chronic viral infections (HIV, hepatitis)

- person under care or protection of vulnerable adults

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
spirometry
The lung function (FEV1) will be assessed at follow-up visits at 2 months, 12 months and 36 months after inclusion.

Locations

Country Name City State
France Cabinet médical Belin Beliet
France Cabinet Médical Cadillac

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Bordeaux Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of blood fibrocytes blood fibrocytes level measured during the suspected exacerbation Day 1
Primary Forced Expiratory Volume (FEV) FEV1 assessed by spirometry month 36
Secondary Forced Expiratory Volume (FEV) FEV1 assessed by spirometry month 2
Secondary Forced Expiratory Volume (FEV) FEV1 assessed by spirometry month 12
Secondary Score of modified Medical Research Council dyspnea scale The MMRC dyspnea scale is a standardized questionnaire validated and measuring the degree of dyspnea in patients with COPD. The scale is an ordinal variable into 5 classes from 0 to 4, a score of 4 representing a major dyspnea. month 2
Secondary Score of modified Medical Research Council dyspnea scale The MMRC dyspnea scale is a standardized questionnaire validated and measuring the degree of dyspnea in patients with COPD. The scale is an ordinal variable into 5 classes from 0 to 4, a score of 4 representing a major dyspnea. month 12
Secondary Score of modified Medical Research Council dyspnea scale The MMRC dyspnea scale is a standardized questionnaire validated and measuring the degree of dyspnea in patients with COPD. The scale is an ordinal variable into 5 classes from 0 to 4, a score of 4 representing a major dyspnea. month 36
Secondary Score of Chronic obstructive pulmonary disease Assessment Test health status measured by CAT (http://www.catestonline.org/english/index_France.htm) month 2
Secondary Score of Chronic obstructive pulmonary disease Assessment Test health status measured by CAT (http://www.catestonline.org/english/index_France.htm) month 12
Secondary Score of Chronic obstructive pulmonary disease Assessment Test health status measured by CAT (http://www.catestonline.org/english/index_France.htm) month 36
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