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

NCT05654597 | Terminated

• 1 other identifier: 2022-A00209-34
• Study Type: observational
• Target: 1,002
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Pulmonary Disease; Lung Diseases; Lung Diseases, Obstructive

Keywords

COPD; Asthma; Case finding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of patients who have taken steps to enter a healthcare pathway 6 months after the referral to a doctor

  6 months after

• Primary care investigators' opinion of the CAPTURE tool used in this study

  Baseline to 2 years

Study Arms (1)

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; Other: Spirometry

Interventions

CAPTURE tool OTHER

CAPTURE 5-item questionnaire and a selected use of peak expiratory flow measurement.

Participants aged 40 or more, without diagnosis of COPD or asthma

Spirometry OTHER

Spirometry performed with a portable device, used for comparison with the CAPTURE tool.

Participants aged 40 or more, without diagnosis of COPD or asthma

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe Hospitalier du Havre: lead

Study Sites (1)

Groupe Hospitalier du Havre

Le Havre, Normandy, 76600, France

Location

MeSH Terms

Conditions

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: April 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

FR (1)