Testing a locally adapted approach to identify and care for chronic obstructive pulmonary disease (COPD) earlier in primary care in South America

ISRCTN	ISRCTN33586883
DOI	https://doi.org/10.1186/ISRCTN33586883
Sponsors	Universidad Científica del Sur, Instituto de Efectividad Clínica y Sanitaria
Funder	National Institute for Health and Care Research

Submission date: 12/11/2026
Registration date: 13/11/2026
Last edited: 13/11/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Chronic obstructive pulmonary disease (COPD) is a long-term lung condition that can make breathing difficult. Many people in South America may not know they have COPD, so they miss out on care and support. This study will develop and test whether a locally adapted approach to finding and caring for people with COPD can be used in primary care in Argentina, Brazil and Peru. It will assess whether the approach is practical to deliver; it is not designed to prove that it improves health.

Who can participate?
Adults aged 50 or over who live near participating primary care centres may be invited for COPD screening. People already diagnosed with COPD may also be invited to take part in the care pathway.

What does the study involve?
Around 3,000 people (in each country) aged 50 or over are expected to be offered screening over six months. Screening may include questions about breathing and risk factors, and a peak-flow breathing test. People with a positive screen will be offered a lung function test called spirometry. People diagnosed with COPD will be offered care and follow-up based on the locally adapted pathway. Participants may complete questionnaires at the start and during follow-up, and some may be invited to an interview. The study plans to collect follow-up information at 6 and 12 months.

What are the possible benefits and risks of participating?
Taking part may help identify COPD that has not previously been diagnosed and connect people with care. However, a direct benefit to each participant is not guaranteed.

Where is the study run from?
The study will take place in selected regions of Argentina, Brazil and Peru.

When is the study starting and how long is it expected to run for?
November 2026 to June 2028

Who is funding the study?
The study is funded by the National Institute for Health and Care Research (NIHR), award NIHR156261.

Who is the main contact?
Dr Onaedo Ilozumba, u.ilozumba@bham.ac.uk

Contact information

Dr Onaedo Ilozumba
Scientific

Room 212
Murray Learning Building
University of Birmingham
Birmingham
B15 2FG
United Kingdom

ORCID ID	0000-0003-4951-9631
Phone	+44(0) 7404187819
Email	u.ilozumba@bham.ac.uk

Ms Jo Hawley
Public

Room 212
Murray Learning Building
University of Birmingham
Birmingham
B15 2FG
United Kingdom

Phone	+44 (0) 7967 372585
Email	s.hawley-woodall@bham.ac.uk

Prof Rachel Jordan
Principal investigator

Room 212
Murray Learning Building
University of Birmingham
Birmingham
B15 2FG
United Kingdom

ORCID ID	0000-0002-0747-6883
Phone	+44 (0) 7816388432
Email	r.e.jordan@bham.ac.uk

Dr Antonio Bernabe-Ortiz
Principal investigator

Panamericana Sur Km. 19
Lima
150142
Peru

ORCID ID	0000-0002-6834-1376
Phone	+51 937 805 894
Email	abernabeo@cientifica.edu.pe

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Health services research, Feasibility testing
Scientific title	Feasibility of a locally adapted primary care pathway for the early diagnosis and management of chronic obstructive pulmonary disease in South America: Breathe Well South America
Study acronym	Breathe Well South America
Study objectives
Ethics approval(s)	1. Approved 18/09/2026, Institutional Research Ethics Committee of Universidad Científica del Sur (CIEI-CIENTÍFICA) (Campus Villa 2 - Panamericana Sur Km 19 , Lima, 150142, Peru; +51 9341642912 ; cieicientifica@cientifica.edu.pe), ref: 165-2025-PRO99 2. Approved 27/08/2026, Institutional Review Board for Research Studies (CIREI) (Fundación Médica de Mar del Plata, Hospital Privado de Comunidad, Córdoba 4545, Mar del Plata, B7602CBM, Argentina; +54 223 499 0000 Int 5435; investigacion@hpc.org.ar), ref: EX-2026-07690429-GDEBA-CCISMSALGP 3. Approved 31/08/2026, THE ETHICS COMMITTEE OF THE PROVINCIAL COUNCIL FOR THE ETHICAL EVALUATION OF HEALTH RESEARCH (CoPEIS) (Av. Ortiz de Ocampo 1700, La Rioja, La Rioja, 5300, Argentina; +54 (261) 423-4425; carloslaino25@gmail.com), ref: 023/2025 4. Approved 14/11/2025, Comitê de Ética em Pesquisa do Hospital Universitário da Universidade de São Paulo (Av. Lauro Gomes, 2000 - Prédio CEPES - 1º andar - sala 30 e 31 - Santo André-SP, CEP, Sao Paulo, 09060-870, Brazil; +55 (11) 3091-9457; cep@hu.usp.br), ref: 79609024.0.1001.0076 5. Approved 11/05/2026, Comitê de Ética em Pesquisa (CEP) da Universidade Federal do Maranhão - UFMA ( Avenida dos Portugueses, 1966 CEB Velho Cidade Universitária Dom Delgado, Bacanga, São Luis/MA, CEP, Maranhão, 65080-805, Brazil; + 55 98 3272-8708; atecepufma@ufma.br), ref: 79609024.0.3005.5087 6. Approved 10/02/2026, Comitê de Ética em Pesquisa (CEP) do Centro Universitário FMABC (Av. Lauro Gomes, 2000 - Prédio CEPES - 1º andar - sala 30 e 31 - Santo André-SP, Santo André, 09060-870, Brazil; +55 (11) 4993-5453; cep@fmabc.br), ref: 9609024.0.3002.0082 7. Approved 31/05/2025, Comitê de Ética em Pesquisa (CEP) UFAM - Hospital Universitário Getúlio Vargas (Rua Tomás de Vila Nova, 300, 5º andar, Torre II, Centro, Manaus/AM, CEP, Manaus, 69020-545, Brazil; +55 92 3305-4707; cep.hugv-ufam@ebserh.gov.br), ref: 79609024.0.2001.9167
Health condition(s) or problem(s) studied	Chronic obstructive pulmonary disease (COPD)
Intervention	In each country, approximately 3,000 adults aged 50 years or older will be recruited from the catchment areas of 6–8 primary healthcare centres over six months. Recruitment may take place through house-to-house visits, primary healthcare centres, condition specific clinics such as tuberculosis clinics, hospitals, or other locally appropriate sources. The study aims to identify approximately 150–200 new cases of COPD, while also recruiting all known COPD cases residing within the defined catchment areas. Before participation, individuals will receive study information and a participant information sheet. Written informed consent will be obtained, and only individuals able to understand the study and provide consent will be included. People with an active respiratory infection will be rescheduled until recovery. The screening assessment will be conducted with a standardised Symptom- and exposure-based questionnaire (SBQ) and peak flow measurement. Data will be collected using pre-programmed REDCap forms. A positive screen will be defined as either an SBQ score of 17 or higher or a peak flow of ≤250 L/min for women or ≤350 L/min for men. Participants with a positive screening result, together with individuals already known to have COPD, will be referred for diagnostic spirometry at an appropriate healthcare facility. Post-bronchodilator spirometry will be offered in all participating countries; prebronchodilator spirometry will additionally be offered in Brazil in accordance with national policy. All participants will complete baseline questionnaires covering sociodemographic characteristics, COPD knowledge and patient activation, symptoms, health behaviours, healthcare utilisation and quality of life. Questionnaires may be self-administered or completed with assistance from a trained interviewer using REDCap. Participants with confirmed COPD will enter a management and follow-up phase based on the locally developed care pathway.Management may include agreed pharmacological treatment, referral to smoking cessation services, pulmonary rehabilitation or exercise programmes, self-management plans and routine follow-up. A modified version of the baseline questions will be repeated during follow-up. The feasibility study is focused on the evaluation of the delivery of the locally relevant care pathway, and specifically who, how and where the management will take place. Clinical and implementation outcomes will be assessed at six and twelve months, using information collected through study procedures, participant self-report and review of relevant medical records. The study will therefore combine case-finding, diagnostic assessment, routine-care management and follow-up monitoring within existing primary healthcare pathway.
Intervention type	Other
Primary outcome measure(s)	Work productivity and activity impairment measured using work productivity and activity impairment (WPAI) questionnaire at baseline, 6-months, 12-months Exercise levels measured using Godin Leisure-Time Exercise questionnaire at baseline, 6-months, 12-months Quality of life measured using EQ-5D-5L/EQ-5D-3L at baseline, 6-months, 12-months Quality of life measured using GAD-7 at baseline, 6-months, 12-months Quality of Life measured using CAT score at baseline, 6-months, 12-months Quality of Life measured using MRC dyspnoea score at baseline, 6-months, 12-months Adherence to medication measured using Test of the Adherence to Inhalers (TAI) questionnaire at baseline, 6-months, 12-months Patient Activation measured using Patient Activation Measure questionnaire at baseline, 6-months, 12-months Health care expenditure measured using Out-of-Pocket Expenditure questionnaire at baseline, 6-months, 12-months Healthcare utilisation measured using Health service utilisation questionnaire at baseline, 6-months, 12-months COPD Exacerbations measured using COPD Exacerbations questionnaire at baseline, 6-months, 12-months Patient uptake measured using percentage invited that attend at each stage of the pathway at baseline, 6-months, 12-months Patient representativeness measured using characteristics of attenders’ vs non-attenders at baseline, 6-months, 12-months Delivery of guideline-based care measured using healthcare records at 6-months, 12-months Quality of Indicators measured using conformance, completeness, plausibility of our new COPD indicators recorded within healthcare records at 6-months, 12-months
Key secondary outcome measure(s)
Completion date	30/06/2028

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	50 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	600
Key inclusion criteria	1. Aged 50 years or older 2. Residing in the catchment area of selected primary health care facilities 3. Participants able to understand and give consent
Key exclusion criteria	Patients with active respiratory infections or recent severe acute illness preventing them from participating in a peak flow manoeuvre or spirometry (e.g. heart attack) should be rescheduled for a later time after infection or their health improves
Date of first enrolment	16/11/2026
Date of final enrolment	31/12/2027

Locations

Countries of recruitment

Argentina
Brazil
Peru

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a publicly available repository. In line with the NIHR position on the sharing of research data, when publishing the findings of the research via publications, we will provide a data sharing statement describing how to access the underpinning data. Data relating to publications will be stored in a trusted repository (e.g. https://edata.bham.ac.uk/), in accordance with the NIHR position on the sharing of research data. The correct level of access to the data (open, restricted, closed or upon request) will be determined at the time of publication. If open access is not applicable to the actual data, open access will be given to the metadata.

Individual participant data (IPD) Intention to share

Yes

IPD sharing plan

The datasets generated during and/or analysed during the current study will be stored in a publicly available repository. In line with the NIHR position on the sharing of research data, when publishing the findings of the research via publications, we will provide a data sharing statement describing how to access the underpinning data. Data relating to publications will be stored in a trusted repository (e.g. https://edata.bham.ac.uk/), in accordance with the NIHR position on the sharing of research data. The correct level of access to the data (open, restricted, closed or upon request) will be determined at the time of publication. If open access is not applicable to the actual data, open access will be given to the metadata.

Editorial Notes

13/11/2026: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).