Using oscillometry and FeNO to improve primary care diagnosis of asthma and COPD
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
This study will test whether oscillometry and FeNO measurements help primary care doctors more accurately diagnose asthma and COPD in adults with suspected symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 12 sites (Buenos Aires and 11 other locations) |
| Trial ID | NCT07245576 on ClinicalTrials.gov |
What this trial studies
Adults with suspected asthma (≥18 years) or suspected COPD (≥40 years) who have no prior diagnosis and meet exclusion criteria will undergo oscillometry, FeNO testing, and standard spirometry where feasible. Test results obtained in the primary care/research sites will be compared with specialist clinical diagnosis and spirometry-based criteria to measure diagnostic accuracy. The observational protocol collects diagnostic data at sites in Buenos Aires, Mendoza, and Alexandria without altering routine clinical management. Patients with recent inhaled or oral corticosteroid use or other conditions that affect lung function are excluded to reduce confounding.
Who should consider this trial
Good fit: Adults with new respiratory symptoms who do not already have a confirmed diagnosis of asthma or COPD—specifically those ≥18 for suspected asthma and ≥40 for suspected COPD—are the intended participants.
Not a fit: People with an existing diagnosis of asthma or COPD, recent use of inhaled or oral corticosteroids, or other diseases that affect lung function are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, using oscillometry and FeNO could enable faster and more accurate diagnosis of asthma and COPD in primary care, reducing delays and unnecessary referrals.
How similar studies have performed: FeNO has established utility for detecting eosinophilic airway inflammation and some prior studies suggest oscillometry is promising, but combining these tools as a primary-care diagnostic pathway remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients are eligible to be included in the study if all the following criteria apply and after providing written informed consent: Suspected asthma (asthma group) 1. 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. 2. Patients presenting with symptoms of wheezing, cough, chest tightness, shortness of breath, but without a clinically confirmed diagnosis of asthma. Suspected COPD (COPD group) 1. Patients ≥ 40 years old at the time of signing the ICF. 2. Patients presenting with symptoms of dyspnea, chronic cough or sputum production, but without a clinically confirmed diagnosis of COPD. Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: 1. Prior diagnosis of COPD or asthma. 2. Use of ICS in the last 6 months or use of oral corticosteroids in the last 3 months. 3. Any diseases that influence lung function result such as lung cancer, pneumonia, active pulmonary tuberculosis, pulmonary embolism, and interstitial lung disease. 4. Any history of recent surgery that affects lung function results, including but not limited to thoracotomy surgery, pneumothorax surgery, and thoracic drainage. 5. Contraindication to spirometry or oscillometry test, or allergy to bronchodilator. 6. Currently pregnant or breast-feeding women. 7. If the investigator judges that the patient is unlikely to comply with study procedures, restrictions, and requirements.
Where this trial is running
Buenos Aires and 11 other locations
- Research Site — Buenos Aires, Argentina (Recruiting)
- Research Site — Medoza, Argentina (Recruiting)
- Research Site — Alexandria, Egypt (Not_yet_recruiting)
- Research Site — El Waili, Egypt (Not_yet_recruiting)
- Research Site — Monterrey, Mexico (Not_yet_recruiting)
- Research Site — Santiago de Quer Taro, Mexico (Not_yet_recruiting)
- Research Site — Riyadh, Saudi Arabia (Not_yet_recruiting)
- Research Site — Taichung, Taiwan (Not_yet_recruiting)
- Research Site — Taoyuan City, Taiwan (Not_yet_recruiting)
- Research Site — Dubai, United Arab Emirates (Not_yet_recruiting)
- Research Site — Hanoi, Vietnam (Not_yet_recruiting)
- Research Site — Ho Chi Minh City, Vietnam (Not_yet_recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.