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

Chronic Airway Disease Clinical Trial

Official title:

Evaluating the Efficacy of Impulse Oscillation Before and After Bronchial Provocation Test and Bronchial Dilation Test in Patients With Chronic Airway Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04668027
• Other study ID #: 2020LX0007_ZD
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2021
• Source: Zhujiang Hospital
• Contact: Huapeng Yu
• Phone: +86 020-61643888
• Email: huapengyu[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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; ? Patients with COPD, the standard diagnosis of COPD complied with GOLD 2019; ? 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.

Related Conditions & MeSH terms

• Chronic Airway Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• impulse oscillation(IOS)
The patient is tested for the first IOS after the screening test, and performed the second IOS test immediately after the results of BPT or BDT. The patient takes seats, body relax, make sure the mouthpiece is fully covered by mouth, then clip nose with both hands to cover both sides of the cheek, and then calms breathing one minutes.
• bronchial provocation test(BPT)
Patient needs to cooperate with the inhalation of acetylcholine stimulants with low to high concentrations, and operates in accordance with the standard nebulized administration procedure. Measure FEV1 after each inhalation and take the high value. The interval between the inhalation of two adjacent doses is 5 minutes, until the FEV1 decrease value is =20% of the FEV1 base value or the highest inhalation concentration. The patient needs to cooperate to ensure that the filter is as tight as possible to prevent air leakage, and performs exhalation and inhalation with the greatest strength and fastest speed. After the examination,the patient should inhale the bronchodilator salbutamol sulfate (400ug).
• bronchial dilation test(BDT)
The patient inhales the salbutamol sulfate (400ug). 15 minutes later, the pulmonary function tester is used for measurement. The patient needs to cooperate to ensure that the filter is as tight as possible to prevent air leakage, and to exhale and breathe with the greatest strength and fastest speed. Inhale.

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Value of the Change of IOS after BPT/BDT.	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 ?Z5%??R5%??R20%??R5-R20%??R5-R20/R5%??X5%??Ax% and ?Fres%. 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.	at least 4 weeks of treatment
Primary	The Value of the Change of spirometry after BPT/BDT.	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 ?FVC%??FEV1%??FEV1/FVC%??MMEF%??MEF75%??MEF50% and ?MEF25%.	at least 4 weeks of treatment