Clinical trial NCT04668027: Impulse Oscillation to Evaluate Diagnostic Efficacy in Patients With Chronic Airway Disease
Official title: Evaluating the Efficacy of Impulse Oscillation Before and After Bronchial Provocation Test and Bronchial Dilation Test in Patients With Chronic Airway Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Airway Disease
Keywords: impulse oscillation
bronchial provocation test
bronchial dilation test
asthma
chronic obstructive pulmonary disease
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Value of the Change of IOS after BPT/BDT.
timeFrame: at least 4 weeks of treatment
measure: The Value of the Change of spirometry after BPT/BDT.
timeFrame: at least 4 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Southern Medical University, China
name: Huapeng Yu
role: PRINCIPAL_INVESTIGATOR
References: