Smoking CessationDEBOTANCT04843605
Systematic Screening for COPD in Tabacology Consultation
An observational study of Smoking Cessation, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Smoking Cessation
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2021to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- Adult, Older adult
Study population: patients followed in tabacology unit
Who may be able to join
- 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
Who cannot join
- Patients already followed for COPD
- Contraindication to spirometry
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Systematic Screening for COPD in Tabacology Consultation
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
- Conditions
- Smoking Cessation
- Medical subject headings
- Smoking Cessation
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD DIAGNOSIS
The diagnosis of COPD is performed using a spirometry
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start16 May 2021
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Beaumont, PhD, Principal investigator, CH des pays de Morlaix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843605
- Sponsor's protocol ID
- 29BRC21.0036
- Acronym
- DEBOTA
- Status last verified
- Aug 2024
- First submitted
- 9 Apr 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16387952Fuhrman C, Delmas MC; pour le groupe epidemiologie et recherche clinique de la SPLF. [Epidemiology of chronic obstructive pulmonary disease in France]. Rev Mal Respir. 2010 Feb;27(2):160-8. doi: 10.1016/j.rmr.2009.08.003. Epub 2010 Jan 19. French.
PubMed 20206064
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Systematic Screening for COPD in Tabacology Consultation
- ClinicalTrials.gov ID
- NCT04843605
- Acronym / sponsor ID
- DEBOTA / 29BRC21.0036
- Conditions
- Smoking Cessation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 May 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 13 Apr 2021 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients followed in tabacology unit
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients already followed for COPD
- Contraindication to spirometry
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COPD DIAGNOSIS
Time frame: day 1
The diagnosis of COPD is performed using a spirometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Background: PubMed 16387952Chapman 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.
- Results publication: PubMed 20206064Fuhrman C, Delmas MC; pour le groupe epidemiologie et recherche clinique de la SPLF. [Epidemiology of chronic obstructive pulmonary disease in France]. Rev Mal Respir. 2010 Feb;27(2):160-8. doi: 10.1016/j.rmr.2009.08.003. Epub 2010 Jan 19. French.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Marc Beaumont, PhD principal investigator
CH des pays de Morlaix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, run by University Hospital, Brest 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 12 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD DIAGNOSIS (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04843605, which also lists 2 linked publications.
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 12 Aug 2024.