RecruitingNCT07245576

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

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


Sponsor

AstraZeneca

Enrollment

600 participants

Start Date

Dec 26, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two newer breathing tests — oscillometry (measures lung stiffness with gentle sound waves) and FeNO (measures airway inflammation via a breath test) — against specialist diagnosis to see if these tools can help primary care doctors more accurately diagnose asthma and COPD (chronic obstructive pulmonary disease). **You may be eligible if...** - You are 18 or older - You have symptoms suggesting possible asthma (wheezing, breathlessness, chest tightness) or possible COPD (chronic cough, breathlessness, a history of smoking) - You have been referred to a specialist for further assessment **You may NOT be eligible if...** - You have already been definitively diagnosed with asthma or COPD by a specialist - You have other significant lung diseases - You cannot perform the breathing tests required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(12)

Research Site

Buenos Aires, Argentina

Research Site

Medoza, Argentina

Research Site

Alexandria, Egypt

Research Site

El Waili, Egypt

Research Site

Monterrey, Mexico

Research Site

Santiago de Quer Taro, Mexico

Research Site

Riyadh, Saudi Arabia

Research Site

Taichung, Taiwan

Research Site

Taoyuan City, Taiwan

Research Site

Dubai, United Arab Emirates

Research Site

Hanoi, Vietnam

Research Site

Ho Chi Minh City, Vietnam

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07245576


Related Trials