A Study on the Diagnostic Value of the Methacholine Choline Provocation Test in the Asthmatic Population
Study Details
Study Description
Brief Summary
This study was a multicenter, open, observational study and was divided into two stages; Stage I study includes patients with suspected asthma to observe the diagnostic value and safety of Methacholine Choline Provocation Test. All patients clinically evaluated for bronchial provocation testing were included in the stage II study to further validate the diagnostic value and cutoff value of the methacholine choline provocation test.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This study was a multicenter, open, observational study. The study was divided into two stages; the first stage of the study included a population with suspected asthma and performed a bronchial provocation test, and cumulative provocation dose when forced expiratory volume in one second (FEV1) fell by 20% (PD20 ) data were recorded. Subjects with positive excitation were treated as asthma for 3 months and treatment was considered effective to confirm the diagnosis of asthma. Sensitivity, specificity, and reliability of the methacholine choline provocation test were calculated, and cutoff values were obtained by exploratory analysis based on PD20 values. All patients clinically evaluated for bronchial provocation testing were included in the stage II study to further validate the diagnostic value and cutoff value of the methacholine choline provocation test.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Positive group The group that conducted the Methacholine Choline Provocation Test with Positive result |
Diagnostic Test: Methacholine Choline Provocation Test
Perform methacholine choline provocation test according to the protocol
|
| Negative group The group that conducted the Methacholine Choline Provocation Test with negative result |
Diagnostic Test: Methacholine Choline Provocation Test
Perform methacholine choline provocation test according to the protocol
|
Outcome Measures
Primary Outcome Measures
- Sensitivity, specificity [Baseline up to 3 months]
The sensitivity, specificity of the test were calculated by the results of the test and whether the patient was finally diagnosed with asthma by performing the methacholine choline provocation test in patients suspected of having asthma
Secondary Outcome Measures
- The incidence, severity of adverse events [Baseline up to 1 week]
Safety
Other Outcome Measures
- PD20 cutoff value [through study completion, an average of 2 year]
PD20 cutoff values for asthma diagnosis by methacholine choline provocation test
Eligibility Criteria
Criteria
Inclusion Criteria:
Stage I study:
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clinically evaluated as suspected asthma but have not been previously diagnosed as asthma and require a bronchial provocation test
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Basal lung function FEV1 ≥ 60%
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Meet the requirements for conducting bronchial excitation tests and pulmonary ventilation examinations
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Not currently suffering from or accompanied by other respiratory diseases, including allergic rhinitis, chronic obstructive pulmonary disease, chronic bronchitis, etc.
Stage II study:
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Basal lung function FEV1 ≥ 60%
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Meet the requirements for conducting bronchial excitation tests and pulmonary ventilation examinations
Exclusion Criteria:
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Have had a fatal asthma attack, or have required mechanical ventilation for an asthma attack within the last 3 months
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Definite hypersensitivity reaction to inhaled stimulants or salbutamol or unexplained urticaria
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Severe impairment of basal pulmonary ventilation (FEV1 < 60% of expected value %, or < 1 L in adults)
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Poor cooperation with basal pulmonary function tests that do not meet quality control requirements
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Other conditions that make a bronchial provocation test or pulmonary ventilation function test inappropriate (e.g., recent presence of severe cardiovascular disease, seizures, uncontrolled hypertension, etc.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Chao-yang Hospital, Capital Medical University | Beijing | Beijing | China | |
| 2 | Songshan General Hospital | Chongqing | Chongqing | China | |
| 3 | The First Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China | |
| 4 | Henan Provincial People's Hospital | Zhengzhou | Henan | China | |
| 5 | Tongji Hospital，Tongji Medical College of Hust | Wuhan | Hubei | China | |
| 6 | West China Hospital of Sichuan University | Chengdu | Sichaun | China |
Sponsors and Collaborators
- jingping Zheng
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Investigators
- Principal Investigator: yi Gao, PhD, The First Hospital of Guangzhou Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SX20221101