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

Primary Purpose

Chronic Airway Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

impulse oscillation（IOS）

bronchial provocation test(BPT)

bronchial dilation test(BDT)

About this trial

This is an interventional diagnostic trial for Chronic Airway Disease focused on measuring impulse oscillation, bronchial provocation test, bronchial dilation test, asthma, chronic obstructive pulmonary disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

18-75 years old, no gender limit;
The subject voluntarily cooperated with the research and signed an informed consent form;
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:

History of other lung diseases, such as cystic fibrosis, bronchiolitis obliterans, tuberculosis, lung cancer, etc.;
After taking corticosteroid therapy in the last 4 weeks, respiratory tract infection occurred within 8 weeks;
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.;
In the past 4 weeks, severe hemoptysis and epileptic seizures require medication; severe hyperthyroidism;
Pregnant women;
Other researchers consider it inappropriate.

Sites / Locations

Zhujiang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chronic airway disease group

Arm Description

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.

Outcomes

Primary Outcome Measures

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 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.

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%.

Secondary Outcome Measures

Full Information

NCT ID

NCT04668027

First Posted

December 8, 2020

Last Updated

August 1, 2021

Sponsor

Zhujiang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04668027

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

June 1, 2022 (Anticipated)

Study Completion Date

June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Airway Disease

Keywords

impulse oscillation, bronchial provocation test, bronchial dilation test, asthma, chronic obstructive pulmonary disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

chronic airway disease group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

impulse oscillation（IOS）

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

bronchial provocation test(BPT)

Intervention Description

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).

Intervention Type

Diagnostic Test

Intervention Name(s)

bronchial dilation test(BDT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

The Value of the Change of IOS after BPT/BDT.

Description

Time Frame

at least 4 weeks of treatment

Title

The Value of the Change of spirometry after BPT/BDT.

Description

Time Frame

at least 4 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-75 years old, no gender limit; The subject voluntarily cooperated with the research and signed an informed consent form; 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: History of other lung diseases, such as cystic fibrosis, bronchiolitis obliterans, tuberculosis, lung cancer, etc.; After taking corticosteroid therapy in the last 4 weeks, respiratory tract infection occurred within 8 weeks; 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.; In the past 4 weeks, severe hemoptysis and epileptic seizures require medication; severe hyperthyroidism; Pregnant women; Other researchers consider it inappropriate.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huapeng Yu

Phone

+86 020-61643888

huapengyu@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huapeng Yu

Organizational Affiliation

Southern Medical University, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhujiang Hospital of Southern Medical University

City

Guangzhou

State/Province

Guangdong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huapeng Yu

Phone

+86 020-61643888

huapengyu@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD

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

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