Chronic Obstructive Pulmonary Disease (COPD)NCT07134855
Mitigating Chronic Respiratory Disease Through the Lens of Multimorbidity (MARES3)
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by University College, London at 2 sites in Brazil.
Trial summary
The investigators aim to investigate how individuals attending primary healthcare (PHC) services in Brazil for treatment of non-communicable diseases (NCDs), identified there as having abnormal spirometry or as being at high risk for lung health problems (such as asthma and chronic obstructive pulmonary disease-COPD… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Asthma, Preserved Ratio Impaired Spirometry (PRISM)
- How many people
- 473 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Sep 2025to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with a non-communicable disease and found to be at high risk for, or newly diagnosed with a chronic respiratory disease
Who may be able to join
- Participated in MARES1 and MARES2, which recruited people with non-communicable diseases attending primary healthcare services in Brazil, identified as being at high-risk for, or confirmed as having chronic respiratory diseases.
Who cannot join
- No consent to take part in MARES3.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil2 sites
Multiple primary care sites
São Carlos, São Paulo
Viviane Castello, (+5516) 99992 4777, vivianecastello@ufscar.br
Multiple primary care sites
São Paulo, São Paulo
Viviane Castello, (+5516) 99992 4777, vivianecastello@ufscar.br
About this study
Official title: Evaluating Care Pathways for Chronic Respiratory Diseases in Brazil
The investigators aim to investigate how individuals attending primary healthcare (PHC) services in Brazil for treatment of non-communicable diseases (NCDs), identified there as having abnormal spirometry or as being at high risk for lung health problems (such as asthma and chronic obstructive pulmonary disease-COPD, collectively referred to as chronic respiratory disease (CRDs)) using the COLA-6 questionnaire, are able to access diagnostic testing and treatment.
The investigators will re-assess people diagnosed with abnormal spirometry in the MARES1 study (NCT07050823) or identified as being at high-risk for CRDs in the MARES2 study (NCT07093021). The estimated sample size is 309 from MARES1 and 164 from MARES2 for a total sample size of 473.
Qualitative interviews will be conducted with a diverse subsample of 30 participants to explore their experience accessing CRD diagnosis and treatment, including barriers and facilitators, while all participants will undergo basic data collection and spirometry.
Read the detailed description
The investigators aim to investigate how individuals attending primary healthcare (PHC) services in Brazil for treatment of non-communicable diseases (NCDs), identified there as having abnormal spirometry or as being at high risk for lung health problems (such as asthma and chronic obstructive pulmonary disease-COPD, collectively referred to as chronic respiratory disease (CRDs)) using the COLA-6 questionnaire, are able to access diagnostic testing and treatment.
The study will be carried out in PHC services, including Basic Health Units (BHUs) and Family Health Units (FHUs), located in the municipalities of São Carlos and São Paulo, both in the state of São Paulo, Brazil.
Individuals are being followed up after participation in MARES1 study (NCT07050823) and MARES2 study (NCT07093021), and had been originally recruited from PHC services, including BHUs and FHUs, located in the municipalities of São Carlos and São Paulo, Brazil. People were recruited if they were attending a PHC service for care of a NCD.
At the research visit, all participants will be asked about access to care. In addition, all participants will have application of the CAAT questionnaire, and the ACQ-7 questionnaire for those with asthma, and all participants will have measurement of pre- and post-bronchodilator spirometry and Fraction of Exhaled Nitric Oxide (FeNO).
A semi-structured interviews will be conducted with a sample of 30 patients diagnosed with abnormal spirometry results: 10 with COPD, 10 with asthma, and 10 with PRISm or restriction. These face-to-face interviews will use open-ended questions, be audio-recorded, transcribed, and anonymized before analysis. Participants will be randomly selected to ensure diversity in gender, age, socioeconomic status, and employment background. The interview will explore how participants accessed healthcare services for diagnostic confirmation and treatment, and how this process affected their health status. Topics will include barriers and facilitators, how doubts were clarified, the type of education they received regarding the disease, diagnosis, and treatment, and whether any changes occurred in their lifestyle or routine following diagnosis or treatment.
The qualitative analysis of the interviews will follow Braun and Clarke, which consists of six phases: 1) Familiarization with the data set; 2) Coding; 3) Generation of initial themes; 4) Development and review of themes; 5) Refinement, definition and naming of themes; and 6) Writing. Descriptive statistics will be used to describe responses to questionnaires and lung function testing, including changes from the values recorded at recruitment to MARES1 and MARES2.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Asthma, Preserved Ratio Impaired Spirometry (PRISM)
- Keywords
- chronic obstructive pulmonary disease, asthma, multi-morbidity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers and facilitators to accessing care for those with newly diagnosed / suspected chronic respiratory disease in primary healthcare services in Brazil.
Barriers and facilitators to accessing care for those with newly diagnosed / suspected chronic respiratory disease in primary healthcare services in Brazil, assessed at qualitative interviews.
Measured: A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).
Secondary outcomes (4)
Spirometry
Pre-and post bronchodilator spirometry
Measured: A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).
Disease Control Questionnaire
Chronic Airways Assessment Test (CAAT) questionnaire
Measured: A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).
FeNO
Fractional Exhaled Nitric Oxide
Measured: A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).
Disease Control Questionnaire
ACQ-7 (Asthma Control Questionnaire)
Measured: A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 473 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Sao Carlos
- Responsible party
- Sponsor
- Investigators
- John R Hurst, PhD FRCP, Principal investigator, University College London HospitalsRenata G Mendes, DFisio, Principal investigator, Federal University of Sao Carlos (UFScar), Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134855
- Sponsor's protocol ID
- UCL Worktribe 6981600
- Other IDs
- NIHR 303125
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no plans to share individual responses from qualitative interviews.
Publications
Mendes RG, Leonardi NT, Castello-Simoes V, Kawakami DMO, Souza JVR, Schafauser-Segundo NS, Simoes RP, Pinto FG, Araujo GHG, da Silva MMC, Moriguchi CS, Franco FJBZ, Pires Di Lorenzo VA, Jordan R, Martins S, Siddharthan T, Al Sharmah S, Barber J, Hurst JR. Mitigating chronic respiratory disease through the lens of multimorbidity: the MARES mixed-methods study protocol. BMJ Open. 2026 Jan 16;16(1):e109950. doi: 10.1136/bmjopen-2025-109950.
PubMed 41545050
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Care Pathways for Chronic Respiratory Diseases in Brazil
- ClinicalTrials.gov ID
- NCT07134855
- Acronym / sponsor ID
- UCL Worktribe 6981600
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Asthma, Preserved Ratio Impaired Spirometry (PRISM)
- Keywords
- chronic obstructive pulmonary disease, asthma, multi-morbidity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 473 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Universidade Federal de Sao Carlos
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to investigate how individuals attending primary healthcare (PHC) services in Brazil for treatment of non-communicable diseases (NCDs), identified there as having abnormal spirometry or as being at high risk for lung health problems (such as asthma and chronic obstructive pulmonary disease-COPD, collectively referred to as chronic respiratory disease (CRDs)) using the COLA-6 questionnaire, are able to access diagnostic testing and treatment.
The investigators will re-assess people diagnosed with abnormal spirometry in the MARES1 study (NCT07050823) or identified as being at high-risk for CRDs in the MARES2 study (NCT07093021). The estimated sample size is 309 from MARES1 and 164 from MARES2 for a total sample size of 473.
Qualitative interviews will be conducted with a diverse subsample of 30 participants to explore their experience accessing CRD diagnosis and treatment, including barriers and facilitators, while all participants will undergo basic data collection and spirometry.
Detailed description
The investigators aim to investigate how individuals attending primary healthcare (PHC) services in Brazil for treatment of non-communicable diseases (NCDs), identified there as having abnormal spirometry or as being at high risk for lung health problems (such as asthma and chronic obstructive pulmonary disease-COPD, collectively referred to as chronic respiratory disease (CRDs)) using the COLA-6 questionnaire, are able to access diagnostic testing and treatment.
The study will be carried out in PHC services, including Basic Health Units (BHUs) and Family Health Units (FHUs), located in the municipalities of São Carlos and São Paulo, both in the state of São Paulo, Brazil.
Individuals are being followed up after participation in MARES1 study (NCT07050823) and MARES2 study (NCT07093021), and had been originally recruited from PHC services, including BHUs and FHUs, located in the municipalities of São Carlos and São Paulo, Brazil. People were recruited if they were attending a PHC service for care of a NCD.
At the research visit, all participants will be asked about access to care. In addition, all participants will have application of the CAAT questionnaire, and the ACQ-7 questionnaire for those with asthma, and all participants will have measurement of pre- and post-bronchodilator spirometry and Fraction of Exhaled Nitric Oxide (FeNO).
A semi-structured interviews will be conducted with a sample of 30 patients diagnosed with abnormal spirometry results: 10 with COPD, 10 with asthma, and 10 with PRISm or restriction. These face-to-face interviews will use open-ended questions, be audio-recorded, transcribed, and anonymized before analysis. Participants will be randomly selected to ensure diversity in gender, age, socioeconomic status, and employment background. The interview will explore how participants accessed healthcare services for diagnostic confirmation and treatment, and how this process affected their health status. Topics will include barriers and facilitators, how doubts were clarified, the type of education they received regarding the disease, diagnosis, and treatment, and whether any changes occurred in their lifestyle or routine following diagnosis or treatment.
The qualitative analysis of the interviews will follow Braun and Clarke, which consists of six phases: 1) Familiarization with the data set; 2) Coding; 3) Generation of initial themes; 4) Development and review of themes; 5) Refinement, definition and naming of themes; and 6) Writing. Descriptive statistics will be used to describe responses to questionnaires and lung function testing, including changes from the values recorded at recruitment to MARES1 and MARES2.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with a non-communicable disease and found to be at high risk for, or newly diagnosed with a chronic respiratory disease
Key inclusion criteria (1 listed)
- Participated in MARES1 and MARES2, which recruited people with non-communicable diseases attending primary healthcare services in Brazil, identified as being at high-risk for, or confirmed as having chronic respiratory diseases.
Key exclusion criteria (1 listed)
- No consent to take part in MARES3.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Barriers and facilitators to accessing care for those with newly diagnosed / suspected chronic respiratory disease in primary healthcare services in Brazil.
Time frame: A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).
Barriers and facilitators to accessing care for those with newly diagnosed / suspected chronic respiratory disease in primary healthcare services in Brazil, assessed at qualitative interviews.
4 secondary outcomes
Spirometry
Time frame: A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).
Disease Control Questionnaire
Time frame: A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).
FeNO
Time frame: A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).
Disease Control Questionnaire
Time frame: A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Derived from this study: PubMed 41545050Mendes RG, Leonardi NT, Castello-Simoes V, Kawakami DMO, Souza JVR, Schafauser-Segundo NS, Simoes RP, Pinto FG, Araujo GHG, da Silva MMC, Moriguchi CS, Franco FJBZ, Pires Di Lorenzo VA, Jordan R, Martins S, Siddharthan T, Al Sharmah S, Barber J, Hurst JR. Mitigating chronic respiratory disease through the lens of multimorbidity: the MARES mixed-methods study protocol. BMJ Open. 2026 Jan 16;16(1):e109950. doi: 10.1136/bmjopen-2025-109950.
- Individual participant dataSharing planned: No. We have no plans to share individual responses from qualitative interviews.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John R Hurst, PhD FRCP principal investigator
University College London Hospitals
Renata G Mendes, DFisio principal investigator
Federal University of Sao Carlos (UFScar), Brasil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by University College, London at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viviane Castello ((+5516) 99992 4777, vivianecastello@ufscar.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers and facilitators to accessing care for those with newly diagnosed / suspected chronic respiratory disease in primary healthcare services in Brazil. (time frame: A single assessment visit conducted six months following diagnosis (participants from MARES1) / identification of being at high risk for chronic respiratory disease (participants from MARES2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07134855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.