SmokersICONICNCT04252781
Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
A study testing Exhaustive exploration in people with Smokers and Chronic Obstructive Pulmonary Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Smokers, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Exhaustive exploration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 20 Aug 2020to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria of smokers with spirometry (pre-inclusion)
- Age> 35 years
- Smoking > 20 PA
- Active smoking (cessation < 1 month)
- Signature of consent to participate in Phase I of the study
- 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
Who cannot join
- Known COPD
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Henri MONDOR
Créteil, Île-de-France Region, 94000
About this study
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.
Read the 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.
- Conditions
- Smokers, Chronic Obstructive Pulmonary Disease
- Being tested
- Exhaustive exploration
- Keywords
- Incident Chronic Obstructive Pulmonary Disease, comorbidities, trajectories
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhaustive explorationOther
- clinical investigations
- imagery
- blood assessment
- functional respiratory investigations
- muscle function / skeletal muscle index
| Study group | Role | What they receive |
|---|---|---|
| Exhaustive exploration | Other | Exhaustive exploration of newly diagnosed COPD patients (pulmonary pathology and associated comorbidities) Receives: Other: Exhaustive exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 12 Months
Secondary outcomes (17)
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
Measured: at 3 Months and 6 Months
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
Measured: at 3 Months, 6 Months and 12 Months
Number of steps
Number of steps in the month preceding the visit evaluated by a pedometer
Measured: at 3 Months, 6 Months and 12 Months
Forced Expiratory Volume in one second (FEV1)
Forced Expiratory Volume in one second (FEV1)
Measured: at 3 Months, 6 Months and 12 Months
Hospital Anxiety and Depression scale
Anxious symptoms or depressions
Measured: at 3 Months, 6 Months and 12 Months
FEV 1 / Respiratory function parameters
Respiratory function parameters with FEV 1
Measured: at 12 Months
DLCO / Respiratory function parameters
Respiratory function parameters with DLCO
Measured: at 12 Months
Residual volume / Respiratory function parameters
Respiratory function parameters with residual volume
Measured: at 12 Months
Total lung capacity / Respiratory function parameters
Respiratory function parameters with total lung capacity
Measured: at 12 Months
Arterial stiffness
Arterial stiffness measured by the pulse wave velocity (Complior)
Measured: at 12 Months
LVEF / Echocardiography
LVEF measured by echocardiography
Measured: at 12 Months
Diastolic dysfunction / Echocardiography
diastolic dysfunction measured by echocardiography
Measured: at 12 Months
PAPS / Echocardiography
PAPS measured by echocardiography
Measured: at 12 Months
Skeletal muscle index
Skeletal muscle index evaluated by IDEXA
Measured: at 12 Months
Muscle function
Muscle strength by grip and pinch
Measured: at 12 Months
Hospital Anxiety and Depression scale
Measurement of anxiety symptoms or depression via the Hospital Anxiety and Depression scale.
Measured: at 12 Months
Numbers of deaths
Numbers of deaths
Measured: at 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start20 Aug 2020
- Primary completion7 Jan 2025
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent BOYER, MD, Principal investigator, Assistance Publique Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252781
- Sponsor's protocol ID
- K180305J
- Acronym
- ICONIC
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2020
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
- ClinicalTrials.gov ID
- NCT04252781
- Acronym / sponsor ID
- ICONIC / K180305J
- Conditions
- Smokers, Chronic Obstructive Pulmonary Disease
- Keywords
- Incident Chronic Obstructive Pulmonary Disease, comorbidities, trajectories
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exhaustive exploration | Other | Other: Exhaustive explorationExhaustive exploration of newly diagnosed COPD patients (pulmonary pathology and associated comorbidities) |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Inclusion criteria of smokers with spirometry (pre-inclusion)
- Age> 35 years
- Smoking > 20 PA
- Active smoking (cessation < 1 month)
- Signature of consent to participate in Phase I of the study
Key exclusion criteria (5 listed)
- Known COPD
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exhaustive exploration* clinical investigations * imagery * blood assessment * functional respiratory investigations * muscle function / skeletal muscle index | Other | Exhaustive exploration |
Primary outcome
1-year adverse evolution
Time frame: at 12 Months
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
17 secondary outcomes
Adverse evolution
Time frame: at 3 Months and 6 Months
Exacerbation
Time frame: at 3 Months, 6 Months and 12 Months
Number of steps
Time frame: at 3 Months, 6 Months and 12 Months
Forced Expiratory Volume in one second (FEV1)
Time frame: at 3 Months, 6 Months and 12 Months
Hospital Anxiety and Depression scale
Time frame: at 3 Months, 6 Months and 12 Months
FEV 1 / Respiratory function parameters
Time frame: at 12 Months
DLCO / Respiratory function parameters
Time frame: at 12 Months
Residual volume / Respiratory function parameters
Time frame: at 12 Months
Total lung capacity / Respiratory function parameters
Time frame: at 12 Months
Arterial stiffness
Time frame: at 12 Months
LVEF / Echocardiography
Time frame: at 12 Months
Diastolic dysfunction / Echocardiography
Time frame: at 12 Months
PAPS / Echocardiography
Time frame: at 12 Months
Skeletal muscle index
Time frame: at 12 Months
Muscle function
Time frame: at 12 Months
Hospital Anxiety and Depression scale
Time frame: at 12 Months
Numbers of deaths
Time frame: at 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent BOYER, MD principal investigator
Assistance Publique Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exhaustive exploration in people with Smokers and Chronic Obstructive Pulmonary Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent BOYER, MD ((0) 1 49 81 26 90 ext. + 33, laurent.boyer@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year adverse evolution (time frame: at 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.