A Study to Evaluate the Accuracy of Primary Care Diagnosis Using Oscillometry and Fractional Exhaled Nitric Oxide for Asthma and COPD Versus Specialist Diagnosis in Patients With Suspected Asthma or COPD

What this Trial Is About

Researchers are evaluating new diagnostic methods for asthma and chronic obstructive pulmonary disease (COPD) that can be used in primary care settings. Traditional spirometry relies on patients' ability to perform forceful breathing maneuvers, which can be challenging and limit accurate diagnosis. This observational study aims to assess how well oscillometry and fractional exhaled nitric oxide (FeNO) testing work compared to specialist diagnosis, across six countries in the Middle East, Africa, Asia, and Latin America, to improve early and reliable detection of asthma and COPD. Primary care physicians will be trained to use oscillometry and FeNO testing following international guidelines and will use devices like the Ambulatory Lung Diagnosis System. Patients suspected of having asthma or COPD will be assessed through history, symptom questionnaires, and these tests. If specialist evaluation is not possible on the same day, it will occur within three days. No follow-up visits are planned. The study compares diagnosis accuracy and feasibility between primary care and specialist settings. Participants will provide consent and complete symptom questionnaires, followed by primary care assessments including oscillometry and FeNO testing. Researchers will measure the accuracy of primary care diagnoses against specialist diagnoses using statistical methods and observe agreement, sensitivity, and specificity within one to three days. The study does not require further follow-up, aiming to inform integration of these diagnostic tools into routine primary care for better asthma and COPD identification.

Assess Accuracy of Primary Care Asthma and COPD Diagnosis Using Oscillometry and FeNO vs Specialist Diagnosis