NCT07516184

Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis

A Multicentre Study to Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center study to explore the positive predictive value of bronchodilation test with portable oscillometry compared to either BDT or BPT with spirometry in asthma diagnosis and to compare it with bronchodilation with spirometry (the current gold standard). In the study, the target patients' profile is the suspected asthma patient with asthmatic symptoms (wheezing, shortness of breath, chest tightness, and/or cough) and aim to enroll 500 participants from 25 sites across different regions in China.

Detailed description

Following the completion of informed consent procedures, patients with asthmatic symptoms will proceed to enrollment for inclusion and exclusion criteria review. In addition, blood tests, include complete blood count (CBC) and C-reactive protein (CRP), and chest Computed Tomography (CT) will be done for eligible participants prior to all assessments in the study to ensure excluding participants with respiratory infections and any lung diseases (other than asthma). All the included participants will undergo Fractional exhaled nitric oxide (FeNO) test, BDT with portable oscillometry and spirometry in sequence and complete the Asthma Control Questionnaire-5 (ACQ-5) assessment during Visit 1. For participants with pre-BD FEV1% ≥ 70% will undergo BPT with spirometry as the last assessment in the study. The diagnosis of asthma will be defined as positive BDT (after bronchodilator inhalation, FEV1 increased by ≥12%, and the absolute value of FEV1 increased by ≥200 mL) or positive BPT with spirometry (FEV1% decrease ≥20% after methacholine inhalation). Oscillometry BDT positive is defined as R5 decrease 40%, or X5 increase 50%, or AX decrease 80% after bronchodilator inhalation as recommended in ERS consensus.

Conditions

• Suspected Asthma

Interventions

Type	Name	Description
DEVICE	Pulmonary function Test intervention	enrollment 500 suspect asthma patients

Timeline

• Start date: 2026-06-30
• Primary completion: 2027-06-11
• Completion: 2027-06-11
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

19 sites across 1 country: China