Current diagnostic methods for asthma and chronic obstructive pulmonary disease mostly depend on pulmonary function tests, especially spirometry. While spirometry is a foundational tool, its diagnostic accuracy is often limited by the patient's ability to perform forceful breathing maneuvers, as well as technical and reproducibility challenges, and the need for proper equipment and training. These constraints can compromise effective diagnosis of asthma and COPD in primary care settings. Prompt and accurate diagnosis by primary care physicians is essential for better patient outcomes. Although variable airflow limitation often measured as a change in FEV1 after bronchodilator is a hallmark of asthma, inconsistencies in test quality and reversibility criteria create challenges in distinguishing asthma from COPD. These complexities highlight the need for alternative diagnostic tools beyond traditional spirometry.
This observational study is designed to evaluate the diagnostic accuracy and technical feasibility of using oscillometry and FeNO testing in primary care for suspected asthma and COPD, compared to conventional specialist-based diagnostics. The study will be conducted across 6 countries in the MEA, Asia, and Latin America, with two hospital sites per country. Primary care physicians will be trained in oscillometry and FeNO testing using standardized protocols and tools such as the Ambulatory Lung Diagnosis System following GINA and GOLD guidelines. Eligible patients will provide consent, complete a history and symptom questionnaire, and undergo primary care-based assessment for a provisional diagnosis. If specialist assessment cannot occur the same day, it will be done within three days. No follow-up visits are planned. Study outcomes will inform the feasibility and accuracy of integrating these methods into routine care, aiming to improve the early and reliable diagnosis of asthma and COPD.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients ≥ 18 years old or with legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the ICF.
. Patients presenting with symptoms of wheezing, cough, chest tightness, shortness of breath, but without a clinically confirmed diagnosis of asthma.
. Patients ≥ 40 years old at the time of signing the ICF.
. Patients presenting with symptoms of dyspnea, chronic cough or sputum production, but without a clinically confirmed diagnosis of COPD.
Exclusion criteria
. Prior diagnosis of COPD or asthma.
. Use of ICS in the last 6 months or use of oral corticosteroids in the last 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether oscillometry and a FeNO breath test done in a primary care setting can accurately diagnose asthma or COPD compared to a specialist — does that mean I wouldn't necessarily see a lung specialist as part of this study, and how might that affect how confident we can be in my diagnosis?
2Since this study is measuring how well these two tests together — the oscillometry readings like R5 and X5, and a FeNO level of 50 ppb or higher — match up with what a specialist would conclude, would my participation help clarify my own diagnosis, or is the goal purely to gather research data without me personally benefiting from the specialist comparison?
3This trial doesn't appear to involve a new treatment, just a diagnostic method — so if I joined, would I still be able to start standard asthma or COPD treatment on the usual timeline, or could participation delay getting the care I need right now?
4Oscillometry and FeNO testing are the two key tools being studied here — are these tests already available to me outside of this trial, and if so, is there a reason to consider joining the study rather than just having them done as part of my normal care?
5Given that this is a diagnostic accuracy study rather than a treatment trial, what would happen if the oscillometry and FeNO results point in a different direction from what my current doctor suspects — would I get access to the specialist 'gold standard' review that this trial uses as its benchmark?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy of primary care asthma/COPD diagnosis using oscillometry (ALDS: R5, R20, R5-R20, X5, Ax) plus FeNO ≥50 ppb (Fenom PRO®/ALDS Pro) vs specialist gold standard; metrics: Cohen's kappa, agreement, sensitivity, specificity in overall, asthma, COPD
. Any diseases that influence lung function result such as lung cancer, pneumonia, active pulmonary tuberculosis, pulmonary embolism, and interstitial lung disease.
. Any history of recent surgery that affects lung function results, including but not limited to thoracotomy surgery, pneumothorax surgery, and thoracic drainage.
. Contraindication to spirometry or oscillometry test, or allergy to bronchodilator.
. Currently pregnant or breast-feeding women.
. If the investigator judges that the patient is unlikely to comply with study procedures, restrictions, and requirements.