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

jingping Zheng

Status

Enrolling

Conditions

Asthma

Treatments

Diagnostic Test: Methacholine Choline Provocation Test

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05870436

SX20221101

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,100 estimated patients

Sex

All

Ages

5+ years old

Volunteers

No Healthy Volunteers

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.)