Lung DiseasesNCT05654597
French Validation of the CAPTURE Case Finding Tool for Obstructive Respiratory Disease
An observational study of Lung Diseases and Lung Diseases, Obstructive, run by Groupe Hospitalier du Havre at 1 site in France.
Trial summary
The objective of this multicentre prospective study is to validate CAPTURE as a French case finding tool for undiagnosed patients suffering from obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases, Lung Diseases, Obstructive, Obstructive Pulmonary Disease
- What is being tested?
- CAPTURE tool and Spirometry
- How many people
- 1,002 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2023to 1 Jan 2025
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult men and women over 40 years old will be recruited from a broad range of healthcare professional in primary care across the country. Any patient attending an appointment will be screened for inclusion.
Who may be able to join
- People aged 40 or more,
- Provision of dated and signed informed consent form,
- Currently being treated by a healthcare professional,
- Patients affiliated to the french social security system.
Who cannot join
- Patients previously diagnosed with COPD or asthma,
- Patients with any condition making them unable to perform spirometry or answer a short questionnaire,
- Patients unable to give free and informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this multicentre prospective study is to validate CAPTURE as a French case finding tool for undiagnosed patients suffering from obstructive pulmonary disease.
Read the detailed description
A large number of healthcare professional across the country will screen participants.
Participants willing to participate will have a short interview, and then will have to answer the 5-item CAPTURE questionnaire. They will be assisted to perform a peak expiratory flow measurement with a portable device. The comparison will be made between the CAPTURE decision and a portable spirometry assessing the presence or not of an obstructive disorder.
Patient screened either by the tool or the spirometry will be addressed to a doctor. Follow-up at 6 months will be set up in order to assess the entry or not of those patients to an approved health care pathway.
At the end of each center's participation, a questionnaire will be sent to all healthcare professionals working on the study, to assess the ease of use of spirometry and the CAPTURE tool and its possible implementation in clinical practice.
- Being tested
- CAPTURE tool, Spirometry
- Keywords
- COPD, Asthma, Case finding
- Medical subject headings
- Lung Diseases, Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPTURE toolOther
CAPTURE 5-item questionnaire and a selected use of peak expiratory flow measurement.
SpirometryOther
Spirometry performed with a portable device, used for comparison with the CAPTURE tool.
| Study group | Role | What they receive |
|---|---|---|
| Participants aged 40 or more, without diagnosis of COPD or asthma | Men and women attending aged 40 or more, without previous diagnosis of chronic obstructive pulmonary disease or asthma. Receives: Other: CAPTURE tool; Other: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity and area under the ROC curve of the CAPTURE tool
Sensitivity, specificity and area under the ROC curve of the CAPTURE tool; i.e. its ability to identify undiagnosed patients with an obstructive ventilatory disorder assessed with a portable spirometry.
Measured: Baseline
Secondary outcomes (2)
Number of patients who have taken steps to enter a healthcare pathway 6 months after the referral to a doctor
Number of patients screened by the CAPTURE tool who have taken steps to enter a healthcare pathway 6 months after the referral to a doctor, i.e. the impact of the screening process at 6 months on patient diagnosis, management and follow-up.
Measured: 6 months after
Primary care investigators' opinion of the CAPTURE tool used in this study
Responses on a Likert scale from all investigators to a questionnaire on the easiness of use of spirometry and CAPTURE tool and its implementation in clinical practice once each center's inclusions had been completed.
Measured: Baseline to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Apr 2023
- Primary completion1 Oct 2024
- Study completion1 Jan 2025
Why it stopped: Futility analysis showed that the probability to validate out hypothesis was near from 15%
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654597
- Sponsor's protocol ID
- 2022-A00209-34
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Validation of the CAPTURE Case Finding Tool for Obstructive Respiratory Disease
- ClinicalTrials.gov ID
- NCT05654597
- Acronym / sponsor ID
- 2022-A00209-34
- Keywords
- COPD, Asthma, Case finding
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Futility analysis showed that the probability to validate out hypothesis was near from 15%
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 16 Dec 2022 (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.
The objective of this multicentre prospective study is to validate CAPTURE as a French case finding tool for undiagnosed patients suffering from obstructive pulmonary disease.
Detailed description
A large number of healthcare professional across the country will screen participants.
Participants willing to participate will have a short interview, and then will have to answer the 5-item CAPTURE questionnaire. They will be assisted to perform a peak expiratory flow measurement with a portable device. The comparison will be made between the CAPTURE decision and a portable spirometry assessing the presence or not of an obstructive disorder.
Patient screened either by the tool or the spirometry will be addressed to a doctor. Follow-up at 6 months will be set up in order to assess the entry or not of those patients to an approved health care pathway.
At the end of each center's participation, a questionnaire will be sent to all healthcare professionals working on the study, to assess the ease of use of spirometry and the CAPTURE tool and its possible implementation in clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants aged 40 or more, without diagnosis of COPD or asthma | – | Other: CAPTURE tool, Other: SpirometryMen and women attending aged 40 or more, without previous diagnosis of chronic obstructive pulmonary disease or asthma. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men and women over 40 years old will be recruited from a broad range of healthcare professional in primary care across the country. Any patient attending an appointment will be screened for inclusion.
Key inclusion criteria (4 listed)
- People aged 40 or more,
- Provision of dated and signed informed consent form,
- Currently being treated by a healthcare professional,
- Patients affiliated to the french social security system.
Key exclusion criteria (3 listed)
- Patients previously diagnosed with COPD or asthma,
- Patients with any condition making them unable to perform spirometry or answer a short questionnaire,
- Patients unable to give free and informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAPTURE toolCAPTURE 5-item questionnaire and a selected use of peak expiratory flow measurement. | Other | Participants aged 40 or more, without diagnosis of COPD or asthma |
| SpirometrySpirometry performed with a portable device, used for comparison with the CAPTURE tool. | Other | Participants aged 40 or more, without diagnosis of COPD or asthma |
Primary outcome
Sensitivity, specificity and area under the ROC curve of the CAPTURE tool
Time frame: Baseline
Sensitivity, specificity and area under the ROC curve of the CAPTURE tool; i.e. its ability to identify undiagnosed patients with an obstructive ventilatory disorder assessed with a portable spirometry.
2 secondary outcomes
Number of patients who have taken steps to enter a healthcare pathway 6 months after the referral to a doctor
Time frame: 6 months after
Primary care investigators' opinion of the CAPTURE tool used in this study
Time frame: Baseline to 2 years
Results and safety
The study was stopped early (reason given: Futility analysis showed that the probability to validate out hypothesis was near from 15%). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Diseases and Lung Diseases, Obstructive, run by Groupe Hospitalier du Havre 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 4 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: stopped early, as of the sponsor's last update on 21 Jan 2026. 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 was stopped early (reason given: Futility analysis showed that the probability to validate out hypothesis was near from 15%). Results are not available in the source record.
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?
Sensitivity, specificity and area under the ROC curve of the CAPTURE tool (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.