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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier de la côte Basque

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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