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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04252781
Other study ID # K180305J
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2020
Est. completion date February 2023

Study information

Verified date January 2020
Source Assistance Publique - Hôpitaux de Paris
Contact Laurent BOYER, MD
Phone (0) 1 49 81 26 90
Email laurent.boyer@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Chronic Obstructive Pulmonary Disease (COPD), , secondary to smoking, is a major public health issue with very high direct and indirect costs. The impact on the health system of undiagnosed patients, up to 70% of patients, is increasingly documented. However, systematic spirometry screening remains controversial among smokers in the absence of data to link the detection of new patients with improved management and clinical events and health goals. More generally, there is little data on the evolution of patients in real life once they have entered the care system.

The premise is that with systematic screening in general medicine, it is possible to identify the evolution of newly diagnosed COPD patients, to distinguish the different possible evolutions according to the initial phenotype and the management.


Description:

A description of the population from which the groups or cohorts will be selected Smokers who have a screening spirometry for COPD, either in general medicine, at a pulmonologist or in the CHIC or Henri Mondor hospital respiratory function tests department.

After screening, an equal number of men and women COPD will be included (150 men and 150 women). 1500 smokers will be included to reach 300 smokers with COPD.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date February 2023
Est. primary completion date February 2023
Accepts healthy volunteers No
Gender All
Age group 35 Years and older
Eligibility Inclusion Criteria:

Inclusion criteria of smokers with spirometry (pre-inclusion)

- Age> 35 years

- Smoking > 20 PA

- Signature of consent to participate in Phase I of the study

Inclusion criteria for patients with incidental COPD

- FEV1 / FVC <70% of the theoretical value and / or <LLN (Lower limit of normal)

- Signature of consent to participate in Phase II of the study

Exclusion Criteria:

- Known COPD

- Chronic inflammatory disease or cancer being treated

- No affiliation to the social security or other social protection scheme

- Pregnant or lactating woman

- Patient deprived of liberty or under legal protection (under tutorship or curatorship

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exhaustive exploration
clinical investigations imagery blood assessment functional respiratory investigations muscle function / skeletal muscle index

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type Measure Description Time frame Safety issue
Primary 1-year adverse evolution 1-year adverse evolution defined by a composite criterion associating:
- Occurrence of an additional exacerbation defined by any event requiring the use of the care system (visit to the doctor, emergencies, or hospitalization, for respiratory aggravation) with prescription of antibiotics or systemic steroids
AND/OR
- Increased dyspnea by 1 point on the MMRC dyspnea score
AND/OR
- CAT> 10 or 2 points increase on CAT symptom scores
at 12 Months
Secondary Adverse evolution - Occurrence of an additional exacerbation defined by any event requiring the use of the care system (visit to the doctor, emergencies, or hospitalization, for respiratory aggravation) with prescription of antibiotics or systemic steroids
AND/OR
- Increased dyspnea by 1 point on the MMRC dyspnea score
AND/OR
- CAT> 10 or 2 points increase on CAT symptom scores
at 3 Months and 6 Months
Secondary Exacerbation Occurrence of an additional exacerbation defined by any event requiring the use of the care system (visit to the doctor, emergencies, or hospitalization, for respiratory aggravation) with prescription of antibiotics or systemic steroids at 3 Months, 6 Months and 12 Months
Secondary Number of steps Number of steps in the month preceding the visit evaluated by a pedometer at 3 Months, 6 Months and 12 Months
Secondary Forced Expiratory Volume in one second (FEV1) Forced Expiratory Volume in one second (FEV1) at 3 Months, 6 Months and 12 Months
Secondary Hospital Anxiety and Depression scale Anxious symptoms or depressions at 3 Months, 6 Months and 12 Months
Secondary FEV 1 / Respiratory function parameters Respiratory function parameters with FEV 1 at 12 Months
Secondary DLCO / Respiratory function parameters Respiratory function parameters with DLCO at 12 Months
Secondary Residual volume / Respiratory function parameters Respiratory function parameters with residual volume at 12 Months
Secondary Total lung capacity / Respiratory function parameters Respiratory function parameters with total lung capacity at 12 Months
Secondary Arterial stiffness Arterial stiffness measured by the pulse wave velocity (Complior) at 12 Months
Secondary LVEF / Echocardiography LVEF measured by echocardiography at 12 Months
Secondary Diastolic dysfunction / Echocardiography diastolic dysfunction measured by echocardiography at 12 Months
Secondary PAPS / Echocardiography PAPS measured by echocardiography at 12 Months
Secondary Skeletal muscle index Skeletal muscle index evaluated by IDEXA at 12 Months
Secondary Muscle function Muscle strength by grip and pinch at 12 Months
Secondary Hospital Anxiety and Depression scale Measurement of anxiety symptoms or depression via the Hospital Anxiety and Depression scale. at 12 Months
Secondary Numbers of deaths Numbers of deaths at 12 Months
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