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

NCT04668027 | Unknown

• 1 other identifier: 2020LX0007_ZD
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Airway Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  at least 4 weeks of treatment

• 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%.

  at least 4 weeks of treatment

Study Arms (1)

chronic airway disease group

EXPERIMENTAL

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.

Diagnostic Test: impulse oscillation（IOS）; Diagnostic Test: bronchial provocation test(BPT); Diagnostic Test: bronchial dilation test(BDT)

Interventions

impulse oscillation（IOS） DIAGNOSTIC_TEST

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.

chronic airway disease group

bronchial provocation test(BPT) DIAGNOSTIC_TEST

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).

chronic airway disease group

bronchial dilation test(BDT) DIAGNOSTIC_TEST

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.

chronic airway disease group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Interventions

Bronchial Provocation Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Huapeng Yu

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huapeng Yu

CONTACT

+86 020-61643888; huapengyu@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: January 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)