Systematic Screening for COPD in Tabacology Consultation | NCT04843605

Studies
Systematic Screening for COPD in Tabacology Consultation

NCT04843605

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Aug 12, 2024Actual

Enrollment

112Actual

Phase

Not provided

Conditions

Smoking Cessation

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 16, 2021Actual

Primary Completion Date

Aug 1, 2023Actual

Completion Date

Aug 1, 2023Actual

First Submitted Date

Apr 9, 2021

First Submission Date that Met QC Criteria

Apr 9, 2021

First Posted Date

Apr 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2024

Last Update Posted Date

Aug 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

COPD is a very common disease, an estimated 3 million people are affected in France. Unfortunately, this pathology is under-diagnosed. Several reasons can be mentioned: the banality of the symptoms or the several comorbidities.

Screening faces a major difficulty: the realization of a spirometry. Various studies have shown the complexity of the implementation of mass screening in cities by mini-spirometry.

The COPD World Health Days allow this mass screening but without visibility on the actual entry into a care pathway.

The objective of this study is to assess the impact of systematic screening for COPD during a tabacology consultation

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
COPD DIAGNOSIS	The diagnosis of COPD is performed using a spirometry	day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects over 45 years old, followed in Tabacology unit at CHRU of BREST - No COPD patient or COPD patients not followed for more than 3 years (considered out of care)
No opposition filed

Exclusion Criteria:

Patients already followed for COPD
Contraindication to spirometry
Refusal to participate

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients followed in tabacology unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Beaumont, PhD	CH des pays de Morlaix	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Brest		Brest			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16387952	Background	Chapman KR, Mannino DM, Soriano JB, Vermeire PA, Buist AS, Thun MJ, Connell C, Jemal A, Lee TA, Miravitlles M, Aldington S, Beasley R. Epidemiology and costs of chronic obstructive pulmonary disease. Eur Respir J. 2006 Jan;27(1):188-207. doi: 10.1183/09031936.06.00024505. No abstract available.
20206064	Result

ID	Term
D015438	Health Behavior
D001519	Behavior