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

NCT ID: NCT03181152

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-10

Study Completion Date

2023-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Asthma-COPD Overlap Syndrome Asthma COPD Diagnoses Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ACOS group

Impulse Oscillometry Bronchial Dilation Test if needed

Impulse Oscillometry

Intervention Type DIAGNOSTIC_TEST

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.

Asthma group

Impulse Oscillometry Bronchial Dilation Test if needed

Impulse Oscillometry

Intervention Type DIAGNOSTIC_TEST

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.

COPD group

Impulse Oscillometry Bronchial Dilation Test if needed

Impulse Oscillometry

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Bronchial Dilation Test

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

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YIZHUO GAO

master

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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LI ZHAO, Doctor

Role: STUDY_DIRECTOR

SHENJING HOSPTIAL Affiliated to CHINA MEDICAL UNIVERSITY

Locations

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Shenjing Hospital

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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YIZHUO GAO, Master

Role: CONTACT

86+18940257523

HONGBO LIU, Doctor

Role: CONTACT

86+18940254125

Facility Contacts

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YIZHUO GAO, MASTER

Role: primary

86+18940257523

LIHUA ZHU, MASTER

Role: backup

86+18940255422

Other Identifiers

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SJHX-002

Identifier Type: -

Identifier Source: org_study_id

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