Clinical trial Recruiting at 1 site Observational Ages 30 and up

Finding undiagnosed chronic lung problems in people with other long-term health conditions in Brazil

Official title: Case-Finding for Chronic Respiratory Diseases in People Living With Other Long-Term Conditions

Run by University College, London · NCT07050823 · Data updated 2026-11-12

This project will try two short questionnaires (COLA and SBQ) plus breathing tests to find undiagnosed asthma, COPD, or similar lung problems in people with long-term conditions who attend primary care in São Carlos and São Paulo, Brazil.

Quick facts

Study typeObservational
Ages30 Years and up
SexAll
Enrollment859 (estimated)
SponsorUniversity College, London
Academic / other
Locations2 sites (São Carlos, São Paulo and 1 other locations)
StatusRecruiting
StartedJuly 1, 2025
Main results expectedDecember 2026
Study endsJuly 2027
Registry record updatedJuly 25, 2025
Trial IDNCT07050823 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults attending primary health care in São Carlos or São Paulo with one or more diagnosed non-respiratory long-term conditions (for example cardiovascular disease, diabetes, or hypertension), who are clinically stable, able to complete questionnaires and perform spirometry, and not pregnant or currently treated for active pulmonary tuberculosis.

Probably not a fit

People already known to have asthma or COPD, those who are clinically unstable, pregnant, currently have an acute respiratory infection or active tuberculosis, have cognitive impairment preventing questionnaire completion, or have contraindications to spirometry are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a cross-sectional observational study enrolling about 859 adults with one or more non-respiratory long-term conditions who attend primary health care units in São Carlos and São Paulo. Participants will complete the COLA-6 questionnaire (and SBQ) and undergo lung function testing including post-bronchodilator spirometry and fractional exhaled nitric oxide (FeNO) to establish a reference diagnosis. The investigators will compare the questionnaire results against the spirometry gold standard and report diagnostic performance using receiver operating characteristic (ROC) curves and area under the curve. Routine PHC settings (Basic Health Units and Family Health Units) are used to reflect real-world case-finding in Brazilian primary care.

Why it matters

Potential benefit: If successful, the approach could help primary care teams find more people with previously undiagnosed chronic respiratory disease so they can get appropriate treatment earlier.

How similar studies have gone: Questionnaire-based case-finding combined with spirometry has shown promise in other low-resource and primary care settings, but performance varies by population and the COLA-6 tool's accuracy in Brazilian PHC is being specifically tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Attending primary health care services in Brasil.

Diagnosed with one or more existing, non-respiratory long-term conditions such as cardiovascular disease, diabetes or hypertension.

Exclusion Criteria:

Clinically unstable in the past month (defined as worsening symptoms requiring emergency care or hospitalization).

Current pregnancy.

Active pulmonary tuberculosis or undergoing treatment for pulmonary tuberculosis.

Current acute respiratory infection.

Cognitive impairment that prevents understanding of the case-finding questionnaire, defined as MMSE score ≤20.

Contraindications to spirometry.

Declines to participate in the study.

Where it's running

  • Multiple primary care sites
    São Carlos, São Paulo, Brazil
    Recruiting
  • Multiple primary care sites
    São Paulo, São Paulo, Brazil
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.