Asthma-COPD Overlap SyndromeNCT03181152
The Application of Impulse Oscillometry on the Diagnosis of ACOS,Asthma and COPD.
An observational study of Asthma-COPD Overlap Syndrome and Asthma, run by Shengjing Hospital at 1 site in China.
Trial summary
To Assess the Utility of Impulse Oscillometry on a Differential Diagnosis among the Patients with ACOS,asthma and COPD over Age 40. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Asthma-COPD Overlap Syndrome, Asthma, COPD
- What is being tested?
- Impulse Oscillometry
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2017to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 13Show fewer
- 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:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenjing Hospital
Shenyang, Liaoning, 110004
YIZHUO GAO, MASTER, 86+18940257523, gaoyizhuo.sy@hotmail.com
LIHUA ZHU, MASTER, 86+18940255422, zhulh@sj-hospital.org
About this study
Official title: 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.
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.
- Conditions
- Asthma-COPD Overlap Syndrome, Asthma, COPD, Diagnoses Disease
- Being tested
- Impulse Oscillometry
- Medical subject headings
- Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome, Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impulse OscillometryDiagnostic test
Also called Bronchial Dilation 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.
| Study group | Role | What they receive |
|---|---|---|
| ACOS group | Impulse Oscillometry Bronchial Dilation Test if needed Receives: Diagnostic Test: Impulse Oscillometry | |
| Asthma group | Impulse Oscillometry Bronchial Dilation Test if needed Receives: Diagnostic Test: Impulse Oscillometry | |
| COPD group | Impulse Oscillometry Bronchial Dilation Test if needed Receives: Diagnostic Test: Impulse Oscillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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.
Measured: 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,
Measured: 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.
Measured: 2018-8-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start10 Jun 2017
- Primary completion30 Aug 2018
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma-COPD Overlap SyndromeStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YIZHUO GAO, Shengjing Hospital
- Investigators
- LI ZHAO, Doctor, Study director, SHENJING HOSPTIAL Affiliated to CHINA MEDICAL UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181152
- Sponsor's protocol ID
- SJHX-002
- Status last verified
- Nov 2023
- First submitted
- 5 Jun 2017
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Impulse Oscillometry on the Differential Diagnosis of ACOS,Asthma and COPD.
- ClinicalTrials.gov ID
- NCT03181152
- Acronym / sponsor ID
- SJHX-002
- Conditions
- Asthma-COPD Overlap Syndrome, Asthma, COPD, Diagnoses Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 8 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Assess the Utility of Impulse Oscillometry on a Differential Diagnosis among the Patients with ACOS,asthma and COPD over Age 40.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACOS group | – | Diagnostic Test: Impulse OscillometryImpulse Oscillometry Bronchial Dilation Test if needed |
| Asthma group | – | Diagnostic Test: Impulse OscillometryImpulse Oscillometry Bronchial Dilation Test if needed |
| COPD group | – | Diagnostic Test: Impulse OscillometryImpulse Oscillometry Bronchial Dilation Test if needed |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impulse OscillometryAlso: Bronchial Dilation Test1，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. | Diagnostic test | ACOS group, Asthma group, COPD group |
Primary outcome
Primary Data:physiological parameter of IOS in ACOS/Asthma/COPD group
Time frame: 2018-8-30
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,
Primary Data:physiological graph of IOS in ACOS/Asthma/COPD group
Time frame: 2018-8-30
Graph:Z-Time graph, impedance-volume graph,impedance-spectrum graph, structural parameter graph, Intrabreath graph.
Primary Data:physiological parameter of IOS combing BDT(Bronchial Dilation Test) in ACOS/Asthma/COPD group
Time frame: 2018-8-30
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,
Primary Data:physiological graph of IOS combing BDT(Bronchial Dilation Test) in ACOS/Asthma/COPD group
Time frame: 2018-8-30
Graph(IOS combing BDT):Z-Time graph, impedance-volume graph,impedance-spectrum graph, structural parameter graph, Intrabreath graph.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Asthma-COPD Overlap Syndrome
Not yet recruiting
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Asthma-COPD Overlap Syndrome, Pulmonary Rehabilitation
Not yet recruitingObservational study
Blood Exosomal Multi-omics and Lung Radiomics for Predicting Efficacy and Prognosis of Severe Eosinophilic ACOS With Biologics
Severe Eosinophilic ACOS (Asthma-COPD Overlap)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LI ZHAO, Doctor study director
SHENJING HOSPTIAL Affiliated to CHINA MEDICAL UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma-COPD Overlap Syndrome and Asthma, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YIZHUO GAO, Master (86+18940257523, gaoyizhuo.sy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Data:physiological parameter of IOS in ACOS/Asthma/COPD group (time frame: 2018-8-30). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.