Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With COPD in Primary Care.

NCT04005833 | Terminated

• 1 other identifier: CHUBX 2017/43
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary disease; chronic obstructive; Primary Health Care; Fibrocyte; Respiratory Function Tests

Outcome Measures

Primary Outcomes (2)

• number of blood fibrocytes

  blood fibrocytes level measured during the suspected exacerbation

  Day 1

• Forced Expiratory Volume (FEV)

  FEV1 assessed by spirometry

  month 36

Secondary Outcomes (8)

• Forced Expiratory Volume (FEV)

  month 2

• Forced Expiratory Volume (FEV)

  month 12

• Score of modified Medical Research Council dyspnea scale

  month 2

• Score of modified Medical Research Council dyspnea scale

  month 12

• Score of modified Medical Research Council dyspnea scale

  month 36

Study Arms (1)

COPD exacerbation

COPD exacerbation, compared according to blood fibrocytes level measured during the suspected exacerbation (Day 1)

Diagnostic Test: spirometry

Interventions

spirometry DIAGNOSTIC_TEST

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

COPD exacerbation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 GOLD guidelines (worsening of symptoms with the need for prescribing short acting bronchodilatators, antibiotics or oral corticosteroids).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

Cabinet médical

Belin-Béliet, 33830, France

Location

Cabinet Médical

Cadillac, 33410, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Specific to research: the determination of fibrocytes on EDTA tubes (with Ethylenediaminetetraacetic acid) The samples will be transported fresh to measure the rate of circulating blood fibrocytes by flow cytometry.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases

Interventions

Spirometry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Emmanuel Prothon, MD

  University of Bordeaux

  PRINCIPAL INVESTIGATOR

• Patrick Berger, MD/PhD

  Hospital University, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: July 2, 2019
• Study Start: September 24, 2019
• Primary Completion: March 9, 2021
• Study Completion: June 9, 2021
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)