Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)

NCT04252781 | Recruiting

• 1 other identifier: K180305J
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Smokers; Chronic Obstructive Pulmonary Disease

Keywords

Incident Chronic Obstructive Pulmonary Disease; comorbidities; trajectories

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Adverse evolution

  at 3 Months and 6 Months

• Exacerbation

  at 3 Months, 6 Months and 12 Months

• Number of steps

  at 3 Months, 6 Months and 12 Months

• Forced Expiratory Volume in one second (FEV1)

  at 3 Months, 6 Months and 12 Months

• Hospital Anxiety and Depression scale

  at 3 Months, 6 Months and 12 Months

Study Arms (1)

Exhaustive exploration

OTHER

Exhaustive exploration of newly diagnosed COPD patients (pulmonary pathology and associated comorbidities)

Other: Exhaustive exploration

Interventions

Exhaustive exploration OTHER

* clinical investigations * imagery * blood assessment * functional respiratory investigations * muscle function / skeletal muscle index

Exhaustive exploration

Eligibility Criteria

• Age: 35 Years+
• Gender Eligibility Details: After screening, an equal number of men and women COPD will be included (91 men and 92 women).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Henri MONDOR

Créteil, Île-de-France Region, 94000, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent BOYER, MD

  Assistance Publique Hôpitaux de Paris (AP-HP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent BOYER, MD

CONTACT

(0) 1 49 81 26 90; laurent.boyer@aphp.fr

Lila KACI

CONTACT

(0) 1 49 81 36 24; lila.kaci@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: February 5, 2020
• Study Start: August 20, 2020
• Primary Completion: January 7, 2025
• Study Completion: February 20, 2026
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

FR (1)