- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07575880
Screening for Obstructive Respiratory Disorders in the General Population During the "Mai Poumon 2026" Prevention Campaign: Prevalence and Impact on the Care Pathway (Mai Poumons 26)
May 11, 2026 updated by: Dr SABATINI Marielle, Centre Hospitalier de la côte Basque
Undiagnosed COPD represents a significant issue in terms of morbidity and mortality, as nearly 50% of smokers with chronic respiratory symptoms also experience impaired quality of life and acute events similar to COPD exacerbations.
We aim to study the prevalence of airflow obstruction (AO) and PRISm (preserved ratio impaired spirometry) in the general population.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD), a chronic bronchial disease characterized by irreversible airway obstruction, represents a major public health issue.
It is currently the fifth leading cause of death worldwide and, according to the World Health Organization (WHO), is expected to become the third leading cause by 2030.
Diagnosis is currently based on spirometry, which reveals an obstructive ventilatory disorder (OVD) defined by a forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of less than 0.7.
However, limited access to this examination can make the diagnosis of COPD difficult.
Undiagnosed COPD represents a significant issue in terms of morbidity and mortality, as nearly 50% of smokers with chronic respiratory symptoms also experience impaired quality of life and acute events similar to COPD exacerbations.
A French study involving 424 patients hospitalized for a COPD exacerbation found that 21.9% had not been diagnosed previously, meaning they entered the disease during a severe exacerbation.
The main challenge, therefore, lies in the early identification of COPD patients, particularly through the use of validated self-questionnaires (e.g., Haute Autorité de Santé).
We aim to study the prevalence of airflow obstruction (AO) and PRISm (preserved ratio impaired spirometry) in the general population.
The secondary objectives are: to compare the clinical characteristics of patients with and without AO / with and without PRISm (depending on sample size).
To identify risk factors for AO and/or PRISm (depending on sample size) (female sex, advanced age, BMI, active smoking, respiratory symptoms).
To estimate the prevalence of "undiagnosed" subjects, defined as the presence of OVD without any known respiratory history, and to study their clinical characteristics.
We plan to follow up with participants at 6 months through a telephone contact to assess the practical impact of this screening day and to determine the proportion of those who have received a consultation with a general practitioner, a pulmonologist, or the introduction of a treatment.
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Séverine LABARRERE
- Phone Number: +33559443828
- Email: slabarrere@ch-cotebasque.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Population attending the "9 Mai Poumon 2026" prevention campaign
Description
- Inclusion criteria :
- Age ≥ 18 years
- Participating to the prevention campain "Mai Poumons 2026" on 09 Mai 2026
- Exclusion criteria :
- Contre-indication to perform a spirometry : hemoptysy, pneumothorax, myocardal infarction <1month, thoracic anevrism, recent ophtalmologic, abdominal or thoracic surgery
- Unable to perform a spirometry (understanding, coordination)
- Patient under legal protection
- Patient pregnant or breasting
- Not affiliating to public healthcare
- Patient deprived of liberty
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of newly diagnosed airflow obstruction (AO) and PRISm (preserved ratio impaired spirometry) in the general population
Time Frame: On the day of inclusion
|
Percentage of AO and PRISm detected
|
On the day of inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Description of the clinical characteristics of patients with and without Airflow Obstruction / with and without PRISm
Time Frame: At the day of inclusion
|
Percentage of presence of symptoms, specific treatment
|
At the day of inclusion
|
|
Description of the population participating to the prevention campaing
Time Frame: At the day of inclusion
|
Percentage of presence of tabagism
|
At the day of inclusion
|
|
Evaluation of the number of patients diagnosed with airflow obstruction or Prism and who attend a consult with a medical doctor after the prevention campain
Time Frame: At Month 6
|
Percentage of patients with a medical follow-up at 6 months
|
At Month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 9, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
May 4, 2026
First Submitted That Met QC Criteria
May 4, 2026
First Posted (Actual)
May 8, 2026
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pathological Conditions, Signs and Symptoms
- Pulmonary Disease, Chronic Obstructive
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Techniques, Respiratory System
- Respiratory Function Tests
- Spirometry
Other Study ID Numbers
- P-2026/07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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