Mitigating Chronic Respiratory Disease Through the Lens of Multi-Morbidity

NCT07050823 | Recruiting

• 2 other identifiers: 6981600NIHR 303125
• Study Type: observational
• Target: 859
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators aim to make it easier to find people with undiagnosed long-term lung health problems (such as asthma, and chronic obstructive pulmonary disease, COPD, collectively called 'Chronic Respiratory Diseases', CRDs) living in Brasil. Because people with undiagnosed CRDs often have other medical problems too, such as heart problems, high blood pressure and diabetes (collectively called 'Long Term Conditions', LTC), the investigators will look for undiagnosed CRD in people with LTC when they are attending appointments at local health centres in the cities of Sao Carlos and Sao Paulo. To look for undiagnosed CRDs the investigators will use two questionnaire-based methods called 'COLA' and 'SBQ'. These are quick and simple to do. All participants will also have tests of their lung function completed including spirometry and Fractional Exhaled Nitric Oxide so that the investigators can make a definite diagnosis of CRDs. When the study is complete, the investigators will examine how well the COLA and SBQ questionnaires perform in identifying people with a definite diagnosis of CRD. In total, the investigators aim to recruit 859 people.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Asthma; Preserved Ratio Impaired Spirometry

Keywords

case-finding; chronic obstructive pulmonary disease; asthma; multi-morbidity

Outcome Measures

Primary Outcomes (1)

• Discriminative accuracy of the 'COLA' case-finding questionnaire for diagnosis of abnormal spirometry

  The investigators will report the sensitivity, specificity, positive and negative predictive value for the ability of the 'COLA' case-finding questionnaire to identify people with abnormal post-bronchodilator spirometry.

  Baseline: all assessments are conducted at one visit and the discriminative accuracy of the 'COLA' case-finding questionnaire for diagnosis of abnormal spirometry will use the COLA and spirometry data from the single visit.

Secondary Outcomes (2)

• Discriminative accuracy of the 'COLA' case-finding questionnaire for diagnosis of specific patterns of abnormal spirometry

  Baseline: all assessments are conducted at one visit and the discriminative accuracy of the 'COLA' case-finding questionnaire for diagnosis of asthma, COPD and PRISm will use the COLA and spirometry data from the single visit.

• Discriminative accuracy of the 'SBQ' (symptom based questionnaire) case-finding questionnaire for diagnosis of overall, and specific patterns of abnormal spirometry

  Baseline: all assessments are conducted at one visit and the discriminative accuracy of the 'SBQ' case-finding questionnaire for diagnosis of abnormal spirometry will use the SBQ and spirometry data from the single visit.

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People attending primary care clinics in Brasil for treatment or monitoring of an existing non-respiratory long-term condition, for example cardiovascular disease, diabetes and hypertension.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• Universidade Federal de Sao Carlos: collaborator

Study Sites (2)

Multiple primary care sites

São Carlos, São Paulo, Brazil

RECRUITING

Multiple primary care sites

São Paulo, São Paulo, Brazil

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; 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 Officials

• John R Hurst, PhD FRCP

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

• Renata G Mendes, DFisio/ PPGFt

  Federal University of Sao Carlos (UFScar), Brasil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trial Manager

CONTACT

(+5516) 99992-4777; vivianecastello@ufscar.br

Study Design

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

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 3, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

BR (2)