About this trial
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 7 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Prior diagnosis of COPD or asthma.
Use of ICS in the last 6 months or use of oral corticosteroids in the last 3 months.
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.
Trial population
Total of 600 patients (approximately 300 suspected asthma patients and 300 suspected COPD patients) will be enrolled in this study. The patients will be enrolled in asthma or COPD groups in 1:1 ratio at site-level. Each site will enroll 50 patients (approximately 25 suspected asthma and 25 suspected COPD).
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Primary care diagnosis uses a diagnostic algorithm combining oscillometry and FeNO. Oscillometry: Ambulatory Lung Diagnosis System (ALDS) parameters-respiratory system resistance at 5 Hz (R5), resistance at 20 Hz (R20), difference R5-R20, reactance at 5 Hz (X5), and area of reactance (Ax). FeNO: measured with Fenom PRO® or ALDS Pro devices, using a diagnostic cut-off of ≥50 ppb. Specialist care diagnosis is the comparator: Gold Standard Specialist Care Diagnosis established through standard clinical practice, including pulmonary function tests, spirometry, physiological tests, imaging, laboratory tests, and bronchial provocation tests. Accuracy will be quantified using Cohen's Kappa coefficient, Percentage Agreement, Sensitivity, and Specificity. The analysis will be conducted in the overall population, the asthma group, and the COPD group.
Secondary outcomes
accuracy and agreement between asthma or COPD diagnoses made in primary care with provisional diagnoses derived exclusively from patient history compared to specialist settings diagnosis
To evaluate the accuracy and agreement between asthma or COPD diagnoses made in primary care with provisional diagnoses derived exclusively from patient history compared to specialist settings diagnosis
Other outcomes
Healthcare provider satisfaction with primary care diagnostic tests (oscillometry and FeNO) as measured by a 5-point Likert scale (ranging from 1 'not satisfied at all' to 5 'very satisfied', where higher scores indicate greater satisfaction)
This directly measures the satisfaction scores or experience rating (as per Protocol Section 2, Table 1 and Section 3.1.1.1) using the specified 5-point Likert scale, including its range and interpretation, addressing both Major and Advisory Issues
Primary care provider confidence in their diagnosis (for this patient) as measured by a 5-point Likert scale (ranging from 1 'not at all confident' to 5 'extremely confident', where higher scores indicate greater confidence)
This measures the confidence scores (as per Protocol Section 2, Table 1 and Section 3.1.1.1) of primary care providers in their diagnostic assessment using the specified 5-point Likert scale, including its range and interpretation.
Specialist care provider experience with the diagnostic process at secondary care as measured by a 5-point Likert scale (ranging from 1 'very challenging' to 5 'very straightforward', where higher scores indicate a more straightforward experience)
This measures the experience scores (as per Protocol Section 2, Table 1 and Section 3.1.1.1) of specialist care providers with the diagnostic process, utilizing the specified 5-point Likert scale, including its range and interpretation.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.