Asthma
Conditions
Keywords
asthma diagnosis, Methacholine Choline Provocation Test
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.
Interventions
DIAGNOSTIC_TESTMethacholine Choline Provocation Test
Perform methacholine choline provocation test according to the protocol
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
jingping Zheng
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The incidence, severity of adverse events | Baseline up to 1 week | Safety |
Other
| Measure | Time frame | Description |
|---|---|---|
| PD20 cutoff value | through study completion, an average of 2 year | PD20 cutoff values for asthma diagnosis by methacholine choline provocation test |
Countries
China
Contacts
Primary Contactjingping Zheng
Backup Contactyi Gao
Outcome results
None listed