Evaluating screening strategies for identifying undiagnosed COPD in Brazil: a Breathe Well project

A study to evaluate the test accuracy of different screening strategies for identifying undiagnosed COPD in Brazil, amongst patients (=40 years) with systemic arterial hypertension in primary care

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11377960

Enrollment

1080

Registered

2018-09-21

Start date

2019-02-21

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive Pulmonary Disease Respiratory COPD

Interventions

The study will use a paired design, with all participants receiving the index tests and reference test during the same study assessment. The study will administer three index tests (peak flow, pre-bro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged =40 years 2. Residing in the catchment areas of the participating sites 3. Diagnosed with systemic arterial hypertension

Exclusion criteria

Exclusion criteria: 1. Unable to do spirometry (e.g. dementia, lack of teeth or otherwise cannot make a good seal) 2. Contraindicated for spirometry (chest infection, coughing up blood in the last month, severe angina, high blood pressure (systolic BP =220 mmHg or diastolic =120 mmHg) or history in the last 3 months of tuberculosis, heart attack, detached retina, or surgery on chest/abdomen/brain/ears/eyes) 3. Previous adverse reaction to salbutamol

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 30/04/2019: 1. Pre-bronchodilator peak flow assessed using a Mini-Wright peak flow meter on the day of recruitment 2. Pre-bronchodilator microspirometry of FEV1/FEV6 ratio measured using a Vitalograph COPD-6 microspirometer on the day of recruitment 3. Self-reported COPD symptoms assessed using CAPTURE, CDQ, a symptom-based questionnaire and selected items from the COPD-SQ on the day of recruitment 4. Post-bronchodilator spirometry using ndd Easy On-PC spirometer on the day of recruitment 5. Cost of screening measured at the end of the study Previous primary outcome measures: 1. Pre-bronchodilator peak flow assessed using a Mini-Wright peak flow meter on the day of recruitment 2. Pre-bronchodilator microspirometry of FEV1/FEV6 ratio measured using a Vitalograph COPD-6 microspirometer on the day of recruitment 3. Self-reported COPD symptoms assessed using CAPTURE and COPD Diagnostic Questionnaire (CDQ) questionnaires, plus a revised version of the International Primary Care Airways Guidelines (IPAG) questionnaire (Zhang et al 2016) on the day of recruitment 4. Post-bronchodilator spirometry using ndd Easy On-PC spirometer on the day of recruitment 5. Cost of screening measured at the the end of the study	—

Measure

Time frame

Current primary outcome measures as of 30/04/2019: 1. Pre-bronchodilator peak flow assessed using a Mini-Wright peak flow meter on the day of recruitment 2. Pre-bronchodilator microspirometry of FEV1/FEV6 ratio measured using a Vitalograph COPD-6 microspirometer on the day of recruitment 3. Self-reported COPD symptoms assessed using CAPTURE, CDQ, a symptom-based questionnaire and selected items from the COPD-SQ on the day of recruitment 4. Post-bronchodilator spirometry using ndd Easy On-PC spirometer on the day of recruitment 5. Cost of screening measured at the end of the study Previous primary outcome measures: 1. Pre-bronchodilator peak flow assessed using a Mini-Wright peak flow meter on the day of recruitment 2. Pre-bronchodilator microspirometry of FEV1/FEV6 ratio measured using a Vitalograph COPD-6 microspirometer on the day of recruitment 3. Self-reported COPD symptoms assessed using CAPTURE and COPD Diagnostic Questionnaire (CDQ) questionnaires, plus a revised version of the International Primary Care Airways Guidelines (IPAG) questionnaire (Zhang et al 2016) on the day of recruitment 4. Post-bronchodilator spirometry using ndd Easy On-PC spirometer on the day of recruitment 5. Cost of screening measured at the the end of the study

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Secondary

Measure	Time frame
1. Test performance of screening strategies, using a combination of spirometry data and clinical confirmation to define COPD 2. Test performance of screening strategies, using an FEV1/FVC ratio of <0.7 to define COPD 3. Optimal cut-points for the screening tests, assessed by repeating primary analyses while applying different thresholds to the questionnaires, peak flow and microspirometry tests to indicate possible COPD. All analyses will be conducted once data collection has closed.	—

Measure

Time frame

1. Test performance of screening strategies, using a combination of spirometry data and clinical confirmation to define COPD 2. Test performance of screening strategies, using an FEV1/FVC ratio of <0.7 to define COPD 3. Optimal cut-points for the screening tests, assessed by repeating primary analyses while applying different thresholds to the questionnaires, peak flow and microspirometry tests to indicate possible COPD. All analyses will be conducted once data collection has closed.

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Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026