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

NCT03181152 | Unknown

• 1 other identifier: SJHX-002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma-COPD Overlap Syndrome; Asthma; COPD; Diagnoses Disease

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

ACOS group

Impulse Oscillometry Bronchial Dilation Test if needed

Diagnostic Test: Impulse Oscillometry

Asthma group

Impulse Oscillometry Bronchial Dilation Test if needed

Diagnostic Test: Impulse Oscillometry

COPD group

Impulse Oscillometry Bronchial Dilation Test if needed

Diagnostic Test: Impulse Oscillometry

Interventions

Impulse Oscillometry 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.

Also known as: Bronchial Dilation Test

ACOS group; Asthma group; COPD group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 1.1 ACOS:
• Patient is older than 40 years old.
• There are characteristics of bronchial asthma and COPD.
• There is a history of exposure to risk factors.
• Existence of persistent airflow limitation: After the application of bronchodilators, FEV1/FVC\<0.7, and lung function proved reversible exhalation.
• The existence of reversible airflow limitation: Bronchial Dilation Test positive.
• Asthma: 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.
• )previously diagnosed asthma. 1.3COPD:
• Patient is older than 40 years old.
• Complaints about dyspnea, chronic cough or expectoration.
• There is a history of exposure to risk factors.
• Existence of persistent airflow limitation: After the application of bronchodilators, FEV1/FVC\<0.7.
• The existence of irreversible airflow limitation: Bronchial Dilation Test negative.

You may not qualify if:

• \- 2.1 Combining other respiratory diseases that affect airflow,such as lung cancer, tuberculosis, pneumonia and bronchiectasis.
• 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.
• Using special accompanying medication. For example, patients with drugs such as glucocorticoid.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shenjing Hospital

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome; Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• LI ZHAO, Doctor

  SHENJING HOSPTIAL Affiliated to CHINA MEDICAL UNIVERSITY

  STUDY DIRECTOR

Central Study Contacts

YIZHUO GAO, Master

CONTACT

86+18940257523; gaoyizhuo.sy@hotmail.com

HONGBO LIU, Doctor

CONTACT

86+18940254125; liuhb@sj-hospital.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 8, 2017
• Study Start: June 10, 2017
• Primary Completion: August 30, 2018
• Study Completion: December 30, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)