Impulse Oscillation to Evaluate Diagnostic Efficacy in Patients With Chronic Airway Disease

Not Applicable

• Conditions: Chronic Airway Disease
• Interventions: Diagnostic Test: impulse oscillation（IOS）; Diagnostic Test: bronchial provocation test(BPT); Diagnostic Test: bronchial dilation test(BDT)

• Registration Number: NCT04668027
• Lead Sponsor: Zhujiang Hospital

Brief Summary

The aim of the research is to explore the diagnostic efficacy of impulse oscillation (IOS) before and after bronchial provocation test (BPT) and bronchial dilation test (BDT) in chronic airway disease.

Detailed Description

The present study has the following objectives:

to explore the diagnostic value of IOS before and after BPT/BDT in chronic airway disease, to assess the diagnostic accuracy of IOS in chronic airway disease with special regard to its discriminating value between asthma and chronic obstructive pulmonary disease, to evaluate the characteristics of airway resistance after BPT/BDT, to evaluate the airway reversibility and hyperresponsiveness（AHR）in asthma.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-16
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-01
• Last Update Posted: 2021-08-09
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

1. 18-75 years old, no gender limit;

2. The subject voluntarily cooperated with the research and signed an informed consent form;

3. Meet any of the following three criteria:

   • Patients with asthma, the standard diagnosis of asthma complied with the GINA 2019; ② Patients with COPD, the standard diagnosis of COPD complied with GOLD 2019; ③ The subjects in the healthy control group had normal vital capacity (baseline FEV1≥80% of the predicted value, FEV1/FVC was greater than the Lower Limit of Normal, and with negative result of BPT or BDT).

Exclusion Criteria

1. History of other lung diseases, such as cystic fibrosis, bronchiolitis obliterans, tuberculosis, lung cancer, etc.;
2. After taking corticosteroid therapy in the last 4 weeks, respiratory tract infection occurred within 8 weeks;
3. A history of myocardial infarction and stroke in the past 3 months; a history of severe arrhythmia, severe cardiac insufficiency, and unstable angina in the past 4 weeks, etc.;
4. In the past 4 weeks, severe hemoptysis and epileptic seizures require medication; severe hyperthyroidism;
5. Pregnant women;
6. Other researchers consider it inappropriate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chronic airway disease group	impulse oscillation（IOS）	Before the test, patients with FEV1/FVC≥0.7 are divided into the provocation test group, patients with FEV1/FVC \<0.7 are divided into the dilation test group.
chronic airway disease group	bronchial provocation test(BPT)	Before the test, patients with FEV1/FVC≥0.7 are divided into the provocation test group, patients with FEV1/FVC \<0.7 are divided into the dilation test group.
chronic airway disease group	bronchial dilation test(BDT)	Before the test, patients with FEV1/FVC≥0.7 are divided into the provocation test group, patients with FEV1/FVC \<0.7 are divided into the dilation test group.

Primary Outcome Measures

Name	Time	Method
The Value of the Change of IOS after BPT/BDT.	at least 4 weeks of treatment	The value of respiratory reactance and resistance will be measured by Jaeger MasterScreen pulmonary function meter. And the main indicators that will be recorded are ΔZ5%、ΔR5%、ΔR20%、ΔR5-R20%、ΔR5-R20/R5%、ΔX5%、ΔAx% and ΔFres%. The receiver operating characteristic (Receiver Operating Characteristic, ROC) curve will be used to analyze the predictive value of IOS parameters for the positive results of BPT and BDT.
The Value of the Change of spirometry after BPT/BDT.	at least 4 weeks of treatment	The value of spirometry will be performed with a spirometer (Jaeger, Hoechberg, Germany) in accordance with the specifications and performance criteria recommended in the American Thoracic Society (ATS)/European Respiratory Society (ERS) Standardization of Spirometry.And the main indicators that will be recorded are ΔFVC%、ΔFEV1%、ΔFEV1/FVC%、ΔMMEF%、ΔMEF75%、ΔMEF50% and ΔMEF25%.

Trial Locations

Locations (1)

Zhujiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China