A Study on the Diagnostic Value of the Methacholine Choline Provocation Test in the Asthmatic Population

Asthma Clinical Trial

Official title:

A Study on the Diagnostic Value of the Methacholine Choline Provocation Test in the Asthmatic Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870436
• Other study ID #: SX20221101
• Status: Recruiting
• Start date: May 19, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: jingping Zheng
• Phone: 18928868238
• Email: jpzhenggy[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

Stage I study:

• clinically evaluated as suspected asthma but have not been previously diagnosed as asthma and require a bronchial provocation test

• Basal lung function FEV1 = 60%

• Meet the requirements for conducting bronchial excitation tests and pulmonary ventilation examinations

• Not currently suffering from or accompanied by other respiratory diseases, including allergic rhinitis, chronic obstructive pulmonary disease, chronic bronchitis, etc.

Stage II study:

• Basal lung function FEV1 = 60%

• Meet the requirements for conducting bronchial excitation tests and pulmonary ventilation examinations

Exclusion Criteria:

• Have had a fatal asthma attack, or have required mechanical ventilation for an asthma attack within the last 3 months

• Definite hypersensitivity reaction to inhaled stimulants or salbutamol or unexplained urticaria

• Severe impairment of basal pulmonary ventilation (FEV1 < 60% of expected value %, or < 1 L in adults)

• Poor cooperation with basal pulmonary function tests that do not meet quality control requirements

• 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.)

Related Conditions & MeSH terms

• Asthma

Intervention

Diagnostic Test:
• Methacholine Choline Provocation Test
Perform methacholine choline provocation test according to the protocol

Locations

Country	Name	City	State
China	Beijing Chao-yang Hospital, Capital Medical University	Beijing	Beijing
China	West China Hospital of Sichuan University	Chengdu	Sichaun
China	Songshan General Hospital	Chongqing	Chongqing
China	The First Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Tongji Hospital,Tongji Medical College of Hust	Wuhan	Hubei
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
jingping Zheng	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PD20 cutoff value	PD20 cutoff values for asthma diagnosis by methacholine choline provocation test	through study completion, an average of 2 year
Primary	Sensitivity, specificity	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	Baseline up to 3 months
Secondary	The incidence, severity of adverse events	Safety	Baseline up to 1 week