Chronic Airway DiseaseNCT04668027
Impulse Oscillation to Evaluate Diagnostic Efficacy in Patients With Chronic Airway Disease
A study testing impulse oscillation（IOS）, bronchial provocation test(BPT) and bronchial dilation test(BDT) in people with Chronic Airway Disease, run by Zhujiang Hospital at 1 site in China.
Trial summary
The aim of the research is to explore the diagnostic efficacy of impulse oscillation (IOS) before and after bronchial provocation test (BPT) and bronchial dilation test (BDT) in chronic airway disease. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Airway Disease
- What is being tested?
- impulse oscillation（IOS）, bronchial provocation test(BPT) and bronchial dilation test(BDT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jun 2022
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years old, no gender limit;
- The subject voluntarily cooperated with the research and signed an informed consent form;
- Meet any of the following three criteria:
- Patients with asthma, the standard diagnosis of asthma complied with the GINA 2019; ② Patients with COPD, the standard diagnosis of COPD complied with GOLD 2019; ③ The subjects in the healthy control group had normal vital capacity (baseline FEV1≥80% of the predicted value, FEV1/FVC was greater than the Lower Limit of Normal, and with negative result of BPT or BDT).
Who cannot join
- History of other lung diseases, such as cystic fibrosis, bronchiolitis obliterans, tuberculosis, lung cancer, etc.;
- After taking corticosteroid therapy in the last 4 weeks, respiratory tract infection occurred within 8 weeks;
- A history of myocardial infarction and stroke in the past 3 months; a history of severe arrhythmia, severe cardiac insufficiency, and unstable angina in the past 4 weeks, etc.;
- In the past 4 weeks, severe hemoptysis and epileptic seizures require medication; severe hyperthyroidism;
- Pregnant women;
- Other researchers consider it inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Huapeng Yu, +86 020-61643888, huapengyu@aliyun.com
About this study
Official title: Evaluating the Efficacy of Impulse Oscillation Before and After Bronchial Provocation Test and Bronchial Dilation Test in Patients With Chronic Airway Disease
The aim of the research is to explore the diagnostic efficacy of impulse oscillation (IOS) before and after bronchial provocation test (BPT) and bronchial dilation test (BDT) in chronic airway disease.
Read the detailed description
The present study has the following objectives:
to explore the diagnostic value of IOS before and after BPT/BDT in chronic airway disease, to assess the diagnostic accuracy of IOS in chronic airway disease with special regard to its discriminating value between asthma and chronic obstructive pulmonary disease, to evaluate the characteristics of airway resistance after BPT/BDT, to evaluate the airway reversibility and hyperresponsiveness（AHR）in asthma.
- Conditions
- Chronic Airway Disease
- Being tested
- impulse oscillation（IOS）, bronchial provocation test(BPT), bronchial dilation test(BDT)
- Keywords
- impulse oscillation, bronchial provocation test, bronchial dilation test, asthma, chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impulse oscillation（IOS）Diagnostic test
The patient is tested for the first IOS after the screening test, and performed the second IOS test immediately after the results of BPT or BDT. The patient takes 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 calms breathing one minutes.
bronchial provocation test(BPT)Diagnostic test
Patient needs to cooperate with the inhalation of acetylcholine stimulants with low to high concentrations, and operates in accordance with the standard nebulized administration procedure. Measure FEV1 after each inhalation and take the high value. The interval between the inhalation of two adjacent doses is 5 minutes, until the FEV1 decrease value is ≥20% of the FEV1 base value or the highest inhalation concentration. The patient needs to cooperate to ensure that the filter is as tight as possible to prevent air leakage, and performs exhalation and inhalation with the greatest strength and fastest speed. After the examination,the patient should inhale the bronchodilator salbutamol sulfate (400ug).
bronchial dilation test(BDT)Diagnostic test
The patient inhales the salbutamol sulfate (400ug). 15 minutes later, the pulmonary function tester is used for measurement. The patient needs to cooperate to ensure that the filter is as tight as possible to prevent air leakage, and to exhale and breathe with the greatest strength and fastest speed. Inhale.
| Study group | Role | What they receive |
|---|---|---|
| chronic airway disease group | Experimental | Before the test, patients with FEV1/FVC≥0.7 are divided into the provocation test group, patients with FEV1/FVC <0.7 are divided into the dilation test group. Receives: Diagnostic Test: impulse oscillation（IOS）; Diagnostic Test: bronchial provocation test(BPT); Diagnostic Test: bronchial dilation test(BDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Value of the Change of IOS after BPT/BDT.
The value of respiratory reactance and resistance will be measured by Jaeger MasterScreen pulmonary function meter. And the main indicators that will be recorded are ΔZ5%、ΔR5%、ΔR20%、ΔR5-R20%、ΔR5-R20/R5%、ΔX5%、ΔAx% and ΔFres%. The receiver operating characteristic (Receiver Operating Characteristic, ROC) curve will be used to analyze the predictive value of IOS parameters for the positive results of BPT and BDT.
Measured: at least 4 weeks of treatment
The Value of the Change of spirometry after BPT/BDT.
The value of spirometry will be performed with a spirometer (Jaeger, Hoechberg, Germany) in accordance with the specifications and performance criteria recommended in the American Thoracic Society (ATS)/European Respiratory Society (ERS) Standardization of Spirometry.And the main indicators that will be recorded are ΔFVC%、ΔFEV1%、ΔFEV1/FVC%、ΔMMEF%、ΔMEF75%、ΔMEF50% and ΔMEF25%.
Measured: at least 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Jan 2020
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Airway DiseaseStudies of the same condition, open and under way.
- More trials run by Zhujiang 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huapeng Yu, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668027
- Sponsor's protocol ID
- 2020LX0007_ZD
- Status last verified
- Aug 2021
- First submitted
- 8 Dec 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- 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 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Impulse Oscillation Before and After Bronchial Provocation Test and Bronchial Dilation Test in Patients With Chronic Airway Disease
- ClinicalTrials.gov ID
- NCT04668027
- Acronym / sponsor ID
- 2020LX0007_ZD
- Conditions
- Chronic Airway Disease
- Keywords
- impulse oscillation, bronchial provocation test, bronchial dilation test, asthma, chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 16 Dec 2020 (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.
The aim of the research is to explore the diagnostic efficacy of impulse oscillation (IOS) before and after bronchial provocation test (BPT) and bronchial dilation test (BDT) in chronic airway disease.
Detailed description
The present study has the following objectives:
to explore the diagnostic value of IOS before and after BPT/BDT in chronic airway disease, to assess the diagnostic accuracy of IOS in chronic airway disease with special regard to its discriminating value between asthma and chronic obstructive pulmonary disease, to evaluate the characteristics of airway resistance after BPT/BDT, to evaluate the airway reversibility and hyperresponsiveness（AHR）in asthma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic airway disease group | Experimental | Diagnostic Test: impulse oscillation（IOS）, Diagnostic Test: bronchial provocation test(BPT), Diagnostic Test: bronchial dilation test(BDT)Before the test, patients with FEV1/FVC≥0.7 are divided into the provocation test group, patients with FEV1/FVC <0.7 are divided into the dilation test group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years old, no gender limit;
- The subject voluntarily cooperated with the research and signed an informed consent form;
- Meet any of the following three criteria:
Key exclusion criteria (6 listed)
- History of other lung diseases, such as cystic fibrosis, bronchiolitis obliterans, tuberculosis, lung cancer, etc.;
- After taking corticosteroid therapy in the last 4 weeks, respiratory tract infection occurred within 8 weeks;
- A history of myocardial infarction and stroke in the past 3 months; a history of severe arrhythmia, severe cardiac insufficiency, and unstable angina in the past 4 weeks, etc.;
- In the past 4 weeks, severe hemoptysis and epileptic seizures require medication; severe hyperthyroidism;
- Pregnant women;
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 oscillation（IOS）The patient is tested for the first IOS after the screening test, and performed the second IOS test immediately after the results of BPT or BDT. The patient takes 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 calms breathing one minutes. | Diagnostic test | chronic airway disease group |
| bronchial provocation test(BPT)Patient needs to cooperate with the inhalation of acetylcholine stimulants with low to high concentrations, and operates in accordance with the standard nebulized administration procedure. Measure FEV1 after each inhalation and take the high value. The interval between the inhalation of two adjacent doses is 5 minutes, until the FEV1 decrease value is ≥20% of the FEV1 base value or the highest inhalation concentration. The patient needs to cooperate to ensure that the filter is as tight as possible to prevent air leakage, and performs exhalation and inhalation with the greatest strength and fastest speed. After the examination,the patient should inhale the bronchodilator salbutamol sulfate (400ug). | Diagnostic test | chronic airway disease group |
| bronchial dilation test(BDT)The patient inhales the salbutamol sulfate (400ug). 15 minutes later, the pulmonary function tester is used for measurement. The patient needs to cooperate to ensure that the filter is as tight as possible to prevent air leakage, and to exhale and breathe with the greatest strength and fastest speed. Inhale. | Diagnostic test | chronic airway disease group |
Primary outcome
The Value of the Change of IOS after BPT/BDT.
Time frame: at least 4 weeks of treatment
The value of respiratory reactance and resistance will be measured by Jaeger MasterScreen pulmonary function meter. And the main indicators that will be recorded are ΔZ5%、ΔR5%、ΔR20%、ΔR5-R20%、ΔR5-R20/R5%、ΔX5%、ΔAx% and ΔFres%. The receiver operating characteristic (Receiver Operating Characteristic, ROC) curve will be used to analyze the predictive value of IOS parameters for the positive results of BPT and BDT.
The Value of the Change of spirometry after BPT/BDT.
Time frame: at least 4 weeks of treatment
The value of spirometry will be performed with a spirometer (Jaeger, Hoechberg, Germany) in accordance with the specifications and performance criteria recommended in the American Thoracic Society (ATS)/European Respiratory Society (ERS) Standardization of Spirometry.And the main indicators that will be recorded are ΔFVC%、ΔFEV1%、ΔFEV1/FVC%、ΔMMEF%、ΔMEF75%、ΔMEF50% and ΔMEF25%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Huapeng Yu principal investigator
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing impulse oscillation（IOS）, bronchial provocation test(BPT) and bronchial dilation test(BDT) in people with Chronic Airway Disease, run by Zhujiang 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 4 inclusion and 6 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 9 Aug 2021. 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 Huapeng Yu (+86 020-61643888, huapengyu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Value of the Change of IOS after BPT/BDT. (time frame: at least 4 weeks of treatment). The study lists 2 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 9 Aug 2021.