The Application of Impulse Oscillometry on the Diagnosis of ACOS,Asthma and COPD.

The Application of Impulse Oscillometry on the Differential Diagnosis of ACOS,Asthma and COPD.

To Assess the Utility of Impulse Oscillometry on a Differential Diagnosis among the Patients with ACOS,asthma and COPD over Age 40.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Diagnoses Disease; COPD; Asthma-COPD Overlap Syndrome
• Intervention / Treatment: Diagnostic test: Impulse Oscillometry

Detailed Description

ACOS,asthma and COPD are prevalent diseases with similar manifestations and different type airway impairments. The differential diagnosis is not easy because the patients always complain of the similar symptoms and are not able to complete spirometry well.

Impulse Oscillometry System (IOS) is capable of identifying airway obstruction and reactions to bronchodilators by providing impedance data and curves. IOS is also a patient-friendly and valuable tool with minimal demands on patient and requiring only passive cooperation.

IOS is a tool to measure lung function during tidal breathing. The output is a measure of respiratory impedance (Zrs), which include the respiratory resistance (Rrs) and respiratory reactance (Xrs) measured over a range of frequencies (usually from 3 to 35 Hz).

The main objective of this study is to investigate the ability of IOS to measure small airway disease by providing different impedance profiles for participants with ACOS,asthma and COPD. Another objective of this study is to investigate the differential ability to identify three diseases by measuring airway impedance and reactions to bronchodilators.

First,participants completed the IOS test.Second,participants inhaled salbutamol for 200g 15 minutes to repeat the IOS.The investigators collect these 2 data for analysis.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: YIZHUO GAO, MASTER; Phone Number: 86+18940257523; Email: gaoyizhuo.sy@hotmail.com
• Study Contact Backup: Name: HONGBO LIU, Doctor; Phone Number: 86+18940254125; Email: liuhb@sj-hospital.org

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Recruiting
      • Shenjing Hospital
      • Contact: YIZHUO GAO, MASTER; Phone Number: 86+18940257523; Email: gaoyizhuo.sy@hotmail.com
      • Contact: LIHUA ZHU, MASTER; Phone Number: 86+18940255422; Email: zhulh@sj-hospital.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1. Patients that meet one of the diganosis:ACOS,Asthma and COPD.
2. Without factors in exclusion criteria.
3. Over 40 years old.

Description

Inclusion Criteria:

- 1.1 ACOS:

1. Patient is older than 40 years old.
2. There are characteristics of bronchial asthma and COPD.
3. There is a history of exposure to risk factors.
4. Existence of persistent airflow limitation: After the application of bronchodilators, FEV1/FVC<0.7, and lung function proved reversible exhalation.
5. The existence of reversible airflow limitation: Bronchial Dilation Test positive.

1.2Asthma: 1)Patient is older than 40 years old. 2)History of reversible respiratory symptoms. 3) non-smokers. 4)lung function:At least one time proved that the airflow limitation: Bronchial Dilation Test positive.

5)previously diagnosed asthma. 1.3COPD:

1. Patient is older than 40 years old.
2. Complaints about dyspnea, chronic cough or expectoration.
3. There is a history of exposure to risk factors.
4. Existence of persistent airflow limitation: After the application of bronchodilators, FEV1/FVC<0.7.
5. The existence of irreversible airflow limitation: Bronchial Dilation Test negative.

Exclusion Criteria:

- 2.1 Combining other respiratory diseases that affect airflow,such as lung cancer, tuberculosis, pneumonia and bronchiectasis.

2.2 At the time doing lung function test, the factors that affect the airflow limitation are not stopped or just stopped with the time interval not long enough to meet the test standard.

2.3 Using special accompanying medication. For example, patients with drugs such as glucocorticoid.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ACOS group; Impulse Oscillometry Bronchial Dilation Test if needed	Diagnostic test: Impulse Oscillometry; 1，Before the experiment, the patient is arranged to rest 10min. 2, IOS: The patient take 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 calm breathing 1 minutes, the computer is automatically collected data calculation and print out the measurement results. 3, Bronchial Dilation Test: The patient is asked to take IOS again after gaven aerosol inhalation of 200g salbutamol for 15min, the computer is automatically collects the data computation and prints the measurement result.; Other Names: Bronchial Dilation Test
Asthma group; Impulse Oscillometry Bronchial Dilation Test if needed	Diagnostic test: Impulse Oscillometry; 1，Before the experiment, the patient is arranged to rest 10min. 2, IOS: The patient take 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 calm breathing 1 minutes, the computer is automatically collected data calculation and print out the measurement results. 3, Bronchial Dilation Test: The patient is asked to take IOS again after gaven aerosol inhalation of 200g salbutamol for 15min, the computer is automatically collects the data computation and prints the measurement result.; Other Names: Bronchial Dilation Test
COPD group; Impulse Oscillometry Bronchial Dilation Test if needed	Diagnostic test: Impulse Oscillometry; 1，Before the experiment, the patient is arranged to rest 10min. 2, IOS: The patient take 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 calm breathing 1 minutes, the computer is automatically collected data calculation and print out the measurement results. 3, Bronchial Dilation Test: The patient is asked to take IOS again after gaven aerosol inhalation of 200g salbutamol for 15min, the computer is automatically collects the data computation and prints the measurement result.; Other Names: Bronchial Dilation Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Data:physiological parameter of IOS in ACOS/Asthma/COPD group	Parameter : parameter about respiratory impedance (Zrs): Z5,Zrs; parameter about respiratory resistance (Rrs)：R5,R20,R10,R35,R5%,R20%,R10%;R35%,△R5-R20,△R10-R20,△R5-R10； parameter about respiratory reactance (Xrs): X5,X20,X35, other parameter: fres,△AX, Alx,	2018-8-30
Primary Data:physiological graph of IOS in ACOS/Asthma/COPD group	Graph:Z-Time graph, impedance-volume graph,impedance-spectrum graph, structural parameter graph, Intrabreath graph.	2018-8-30
Primary Data:physiological parameter of IOS combing BDT(Bronchial Dilation Test) in ACOS/Asthma/COPD group	Parameter (IOS combing BDT): parameter about respiratory impedance (Zrs): Z5,Zrs; parameter about respiratory resistance (Rrs)：R5,R20,R10,R35,R5%,R20%,R10%;R35%,△R5-R20,△R10-R20,△R5-R10； parameter about respiratory reactance (Xrs): X5,X20,X35, other parameter: fres,△AX, Alx,	2018-8-30
Primary Data:physiological graph of IOS combing BDT(Bronchial Dilation Test) in ACOS/Asthma/COPD group	Graph(IOS combing BDT):Z-Time graph, impedance-volume graph,impedance-spectrum graph, structural parameter graph, Intrabreath graph.	2018-8-30

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Investigators: Study Director: LI ZHAO, Doctor, SHENJING HOSPTIAL Affiliated to CHINA MEDICAL UNIVERSITY

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2017
• Primary Completion (Actual): August 30, 2018
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease; Asthma; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
• Other Study ID Numbers: SJHX-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No