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Impulse Oscillation to Evaluate Diagnostic Efficacy in Patients With Chronic Airway Disease

Evaluating the Efficacy of Impulse Oscillation Before and After Bronchial Provocation Test and Bronchial Dilation Test in Patients With Chronic Airway Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04668027
Enrollment
172
Registered
2020-12-16
Start date
2020-01-01
Completion date
2022-06-01
Last updated
2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Airway Disease

Keywords

impulse oscillation, bronchial provocation test, bronchial dilation test, asthma, chronic obstructive pulmonary disease

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTimpulse 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_TESTbronchial 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_TESTbronchial 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.

Sponsors

Zhujiang Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

1. 18-75 years old, no gender limit; 2. The subject voluntarily cooperated with the research and signed an informed consent form; 3. 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).

Exclusion criteria

1. History of other lung diseases, such as cystic fibrosis, bronchiolitis obliterans, tuberculosis, lung cancer, etc.; 2. After taking corticosteroid therapy in the last 4 weeks, respiratory tract infection occurred within 8 weeks; 3. 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.; 4. In the past 4 weeks, severe hemoptysis and epileptic seizures require medication; severe hyperthyroidism; 5. Pregnant women; 6. Other researchers consider it inappropriate.

Design outcomes

Primary

MeasureTime frameDescription
The Value of the Change of IOS after BPT/BDT.at least 4 weeks of treatmentThe 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.at least 4 weeks of treatmentThe 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%.

Countries

China

Contacts

Primary ContactHuapeng Yu
huapengyu@aliyun.com+86 020-61643888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026