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

NCT07245576 | Recruiting

• 1 other identifier: D2287R00214
• Study Type: observational
• Target: 600
• Locations: 7 countries
• Sites: 12

Brief 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.

Conditions

Asthma; COPD

Keywords

Asthma; COPD; Oscillometry; spirometry; Fractional Exhaled Nitric Oxide Test - FeNO; Chronic Obstructive Pulmonary Disease - COPD

Outcome Measures

Primary Outcomes (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

  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.

  1 to 3 days

Secondary Outcomes (1)

• 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

  1 to 3 days

Other Outcomes (3)

• 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)

  1 to 3 days

• 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)

  1 to 3 days

• 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)

  1 to 3 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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)
• 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.
• Suspected COPD (COPD group)
• 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.

You may not qualify if:

• Patients are excluded from the study if any of the following criteria apply:
• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (12)

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, 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

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: November 24, 2025
• Study Start: December 26, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

SA (1); ME (2); TW (2); AR (2); EG (2); VN (2); AE (1)