French Validation of the CAPTURE Case Finding Tool for Obstructive Respiratory Disease

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.

Study Overview

• Status: Terminated
• Conditions: Lung Diseases; Lung Diseases, Obstructive; Obstructive Pulmonary Disease
• Intervention / Treatment: Other: CAPTURE tool; Other: Spirometry

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 Type: Observational
• Enrollment (Actual): 1002

Contacts and Locations

Study Locations

• France
  • Normandy
    • Le Havre, Normandy, France, 76600
      • Groupe Hospitalier Du Havre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: CAPTURE tool; CAPTURE 5-item questionnaire and a selected use of peak expiratory flow measurement.; Other: Spirometry; Spirometry performed with a portable device, used for comparison with the CAPTURE tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to 2 years

Collaborators and Investigators

• Sponsor: Groupe Hospitalier du Havre

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; COPD; Case finding
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Respiratory Tract Diseases; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pathological Conditions, Signs and Symptoms; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma
• Other Study ID Numbers: 2022-A00209-34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No