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RecruitingNCT03181152Updated Nov 2, 2023

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

An observational study in Asthma-COPD Overlap Syndrome, Asthma and COPD, sponsored by Shengjing Hospital. Recruiting at 1 site in China. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-11-02.

Sponsored by Shengjing Hospital · Observational

From the registry’s dates

  • Started Jun 2017; still recruiting 9 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
40 Years to 90 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Asthma-COPD Overlap Syndrome
  • Asthma
  • COPD
  • Diagnoses Disease

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 100 is below the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Shengjing Hospital is the lead sponsor of 124 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
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.

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

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testImpulse 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.

    Also known as: Bronchial Dilation Test

06

What researchers measure

Primary outcomes

  1. 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,

    Time frame: 2018-8-30

  2. 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.

    Time frame: 2018-8-30

  3. 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,

    Time frame: 2018-8-30

  4. 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.

    Time frame: 2018-8-30

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03181152
Lead sponsor
Shengjing Hospital
Responsible party
YIZHUO GAO (master, Shengjing Hospital) — Principal investigator
First posted
Jun 8, 2017
Start date
Jun 10, 2017
Primary completion
Aug 30, 2018
Completion
Dec 30, 2023 (estimated)
Last update
Nov 2, 2023

Study contacts

YIZHUO GAO, Master
Contact
gaoyizhuo.sy@hotmail.com
86+18940257523
HONGBO LIU, Doctor
Contact
liuhb@sj-hospital.org
86+18940254125
LI ZHAO, Doctor
study director · SHENJING HOSPTIAL Affiliated to CHINA MEDICAL UNIVERSITY

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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