| Condition or disease | Intervention/treatment |
|---|---|
| Chronic Obstructive Pulmonary Disease | Diagnostic Test: spirometry |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 230 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Association Between Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD) in Primary Care |
| Estimated Study Start Date : | September 19, 2019 |
| Estimated Primary Completion Date : | June 1, 2020 |
| Estimated Study Completion Date : | June 1, 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
COPD exacerbation
COPD exacerbation, compared according to blood fibrocytes level measured during the suspected exacerbation (Day 1)
|
Diagnostic Test: spirometry
The lung function (FEV1) will be assessed at follow-up visits at 2 months, 12 months and 36 months after inclusion.
|
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Emmanuel Prothon, MD | +33662539394 | emmanuel.prothon@u-bordeaux.fr |
| France | |
| Cabinet médical | |
| Belin Beliet, France, 33830 | |
| Contact: Isabelle SPINDLER-FOSSE, MD 05 56 72 88 73 ifosse@protonmail.com | |
| Cabinet Médical | |
| Cadillac, France, 33410 | |
| Contact: Emmanuel PROTHON, MD drprothon@gmail.com | |
| Principal Investigator: | Emmanuel Prothon, MD | University of Bordeaux | |
| Study Chair: | Patrick Berger, MD/PhD | Hospital University, Bordeaux |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | February 15, 2019 | ||||||
| First Posted Date | July 2, 2019 | ||||||
| Last Update Posted Date | July 2, 2019 | ||||||
| Estimated Study Start Date | September 19, 2019 | ||||||
| Estimated Primary Completion Date | June 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With COPD in Primary Care. | ||||||
| Official Title | Association Between Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD) in Primary Care | ||||||
| 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. | ||||||
| Detailed 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. |
||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Retention: Samples Without DNA Description:
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.
|
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| 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). | ||||||
| Condition | Chronic Obstructive Pulmonary Disease | ||||||
| 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.
|
||||||
| Study Groups/Cohorts | COPD exacerbation
COPD exacerbation, compared according to blood fibrocytes level measured during the suspected exacerbation (Day 1)
Intervention: Diagnostic Test: spirometry
|
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Not yet recruiting | ||||||
| Estimated Enrollment |
230 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | June 1, 2023 | ||||||
| Estimated Primary Completion Date | June 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 40 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts |
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| Listed Location Countries | France | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT04005833 | ||||||
| Other Study ID Numbers | CHUBX 2017/43 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | University Hospital, Bordeaux | ||||||
| Study Sponsor | University Hospital, Bordeaux | ||||||
| Collaborators | Institut National de la Santé Et de la Recherche Médicale, France | ||||||
| Investigators |
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| PRS Account | University Hospital, Bordeaux | ||||||
| Verification Date | June 2019 | ||||||