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

Recruiting

• Conditions: Asthma
• Interventions: Diagnostic Test: Methacholine Choline Provocation Test

• Registration Number: NCT05870436
• Lead Sponsor: jingping Zheng

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.

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 Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-11
• Study Start: 2023-05-19
• Study First Submitted QC: 2023-05-22
• Last Update Submitted: 2023-05-22
• Study First Posted: 2023-05-23
• Last Update Posted: 2023-05-23
• Primary Completion: 2025-01
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1100

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Negative group	Methacholine Choline Provocation Test	The group that conducted the Methacholine Choline Provocation Test with negative result
Positive group	Methacholine Choline Provocation Test	The group that conducted the Methacholine Choline Provocation Test with Positive result

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The incidence, severity of adverse events	Baseline up to 1 week	Safety

Trial Locations

Locations (6)

Beijing Chao-yang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

The First Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Songshan General Hospital; 🇨🇳 Chongqing, Chongqing, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Tongji Hospital，Tongji Medical College of Hust; 🇨🇳 Wuhan, Hubei, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichaun, China