Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)

Chronic Obstructive Pulmonary Disease Clinical Trial

— ICONIC  

Official title:

Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04252781
• Other study ID #: K180305J
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Smokers

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