Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC) (ICONIC)
Primary Purpose
Smokers, Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exhaustive exploration
Sponsored by
About this trial
This is an interventional diagnostic trial for Smokers focused on measuring Incident Chronic Obstructive Pulmonary Disease, comorbidities, trajectories
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Exhaustive exploration
Arm Description
Exhaustive exploration of newly diagnosed COPD patients (pulmonary pathology and associated comorbidities)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Number of steps
Number of steps in the month preceding the visit evaluated by a pedometer
Forced Expiratory Volume in one second (FEV1)
Forced Expiratory Volume in one second (FEV1)
Hospital Anxiety and Depression scale
Anxious symptoms or depressions
FEV 1 / Respiratory function parameters
Respiratory function parameters with FEV 1
DLCO / Respiratory function parameters
Respiratory function parameters with DLCO
Residual volume / Respiratory function parameters
Respiratory function parameters with residual volume
Total lung capacity / Respiratory function parameters
Respiratory function parameters with total lung capacity
Arterial stiffness
Arterial stiffness measured by the pulse wave velocity (Complior)
LVEF / Echocardiography
LVEF measured by echocardiography
Diastolic dysfunction / Echocardiography
diastolic dysfunction measured by echocardiography
PAPS / Echocardiography
PAPS measured by echocardiography
Skeletal muscle index
Skeletal muscle index evaluated by IDEXA
Muscle function
Muscle strength by grip and pinch
Hospital Anxiety and Depression scale
Measurement of anxiety symptoms or depression via the Hospital Anxiety and Depression scale.
Numbers of deaths
Numbers of deaths
Full Information
NCT ID
NCT04252781
First Posted
January 6, 2020
Last Updated
January 31, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04252781
Brief Title
Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
Acronym
ICONIC
Official Title
Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smokers, Chronic Obstructive Pulmonary Disease
Keywords
Incident Chronic Obstructive Pulmonary Disease, comorbidities, trajectories
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exhaustive exploration
Arm Type
Other
Arm Description
Exhaustive exploration of newly diagnosed COPD patients (pulmonary pathology and associated comorbidities)
Intervention Type
Other
Intervention Name(s)
Exhaustive exploration
Intervention Description
clinical investigations
imagery
blood assessment
functional respiratory investigations
muscle function / skeletal muscle index
Primary Outcome Measure Information:
Title
1-year adverse evolution
Description
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
Time Frame
at 12 Months
Secondary Outcome Measure Information:
Title
Adverse evolution
Description
- 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
Time Frame
at 3 Months and 6 Months
Title
Exacerbation
Description
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
Time Frame
at 3 Months, 6 Months and 12 Months
Title
Number of steps
Description
Number of steps in the month preceding the visit evaluated by a pedometer
Time Frame
at 3 Months, 6 Months and 12 Months
Title
Forced Expiratory Volume in one second (FEV1)
Description
Forced Expiratory Volume in one second (FEV1)
Time Frame
at 3 Months, 6 Months and 12 Months
Title
Hospital Anxiety and Depression scale
Description
Anxious symptoms or depressions
Time Frame
at 3 Months, 6 Months and 12 Months
Title
FEV 1 / Respiratory function parameters
Description
Respiratory function parameters with FEV 1
Time Frame
at 12 Months
Title
DLCO / Respiratory function parameters
Description
Respiratory function parameters with DLCO
Time Frame
at 12 Months
Title
Residual volume / Respiratory function parameters
Description
Respiratory function parameters with residual volume
Time Frame
at 12 Months
Title
Total lung capacity / Respiratory function parameters
Description
Respiratory function parameters with total lung capacity
Time Frame
at 12 Months
Title
Arterial stiffness
Description
Arterial stiffness measured by the pulse wave velocity (Complior)
Time Frame
at 12 Months
Title
LVEF / Echocardiography
Description
LVEF measured by echocardiography
Time Frame
at 12 Months
Title
Diastolic dysfunction / Echocardiography
Description
diastolic dysfunction measured by echocardiography
Time Frame
at 12 Months
Title
PAPS / Echocardiography
Description
PAPS measured by echocardiography
Time Frame
at 12 Months
Title
Skeletal muscle index
Description
Skeletal muscle index evaluated by IDEXA
Time Frame
at 12 Months
Title
Muscle function
Description
Muscle strength by grip and pinch
Time Frame
at 12 Months
Title
Hospital Anxiety and Depression scale
Description
Measurement of anxiety symptoms or depression via the Hospital Anxiety and Depression scale.
Time Frame
at 12 Months
Title
Numbers of deaths
Description
Numbers of deaths
Time Frame
at 12 Months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
After screening, an equal number of men and women COPD will be included (150 men and 150 women).
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent BOYER, MD
Phone
(0) 1 49 81 26 90
Ext
+ 33
Email
laurent.boyer@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
David SCHMITZ
Phone
(0) 1 49 81 36 24
Ext
+33
Email
david.schmitz@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent BOYER, MD
Organizational Affiliation
Assistance Publique Hôpitaux de Paris (AP-HP)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
We'll reach out to this number within 24 hrs