Asthma
Conditions
Brief summary
A multicenter, open-label study to evaluate the sensitivity and specificity of inhaled methacholine in bronchial provocation test
Interventions
Cholinergic agonists
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Patients who meet all the following inclusion criteria can be included in this trial: * 1 Adults 65 years of age ≥ 18 years of age, male or female; * 2 Normal or abnormal pulmonary function test without clinical significance (FEV1 ≥ 70% predicted); * 3 Voluntary, signed informed consent, good compliance, can cooperate with the trial observation. Patients with asthma: * 4 Clinical diagnosis of asthma patients; * 5 Patients who can stop using prohibited concomitant drugs (β2 adrenoceptor agonists, anticholinergics, oral bronchodilators, antihistamines, leukotriene receptor antagonists) within the specified period before airway allergic examination; Healthy subjects: * 6 Body mass index (BMI) = weight (kg)/height2 (m2), and body mass index is within the range of 18.5 \ 27.0 (including the critical value).
Exclusion criteria
Patients with any of the following criteria will not be included in the trial: * 1 Patients with a past history of allergy to this type of reagent; * 2 Patients with a history of heart disease who are difficult to adapt to bronchial provocation test; * 3 Patients who have undergone thoracic or abdominal surgery within 6 months before the trial; * 4 Patients who have undergone surgery for intracranial, ophthalmic diseases, ear, nose and throat diseases, and respiratory diseases 6 months before the trial; * 5 Complicated pneumothorax and other respiratory diseases or tuberculosis and other infectious diseases; * 6 Patients with diseases that may be affected by the use of cholinergic drugs (epilepsy, bradycardia, coronary artery occlusion, vagal tension, thyroid disease, arrhythmia, peptic ulcer, urinary tract disorders, etc.); * 7 Patients with a past history of drug dependence or alcohol dependence; * 8 Previous severe circulatory system diseases, hepatobiliary system diseases, digestive tract diseases, urinary system diseases, kidney diseases, blood diseases, endocrine system diseases, immune system diseases, malignant tumors, etc.; * 9 Patients who are using cholinase inhibitors (treatment of myasthenia gravis); * 10 Patients with unexplained urticaria; * 11 Pregnant and lactating women; * 12 Subjects with dyspnea, wheezing, wheezing on the day of the trial; * 13 Patients with myocardial infarction or stroke, combined with hypertension (systolic blood pressure \> 200 mmHg, diastolic blood pressure \> 100 mmHg); * 14 Poor cooperation in basic pulmonary function tests, not in line with quality control; * 15 Use of drugs that will affect airway systolic function and airway inflammation, thereby affecting airway reactivity and can not be discontinued before the test (bronchodilator drugs, glucocorticoids, anti-allergic drugs and triene receptor antagonists and others); * 16 Current smokers, those who quit for less than one year at the time of screening, and those with a smoking history of more than 10 packs/year; * 17 Abnormalities in physical examination, laboratory tests, vital signs and test-related tests are clinically significant (based on clinician judgment); * 18 The investigators think that there are any unsuitable for inclusion; Patients with asthma: * 1 Hospitalized for asthma exacerbation within 12 weeks; * 2 Patients with combined respiratory diseases (such as COPD, etc.) that may affect the efficacy and safety evaluation of the drug; Healthy subjects: * 1 Have used any drugs in 2 weeks; * 2 Patients, immediate family members suffering from allergic diseases (allergic rhinitis, specific rhinitis, allergic conjunctivitis, chronic urticaria, food allergy, etc.); * 3 Patients with upper respiratory tract infection, acute sinusitis and other infection-related symptoms or have received treatment in 6 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity analysis | On the 1 day of administration | Sensitivity analysis is percentage of asthmatics subjects with positive final challenge compared with total asthmatics subjects in this study. |
| Specificity Analysis | On the 1 day of administration | Specificity is the percentage of healthy subjects with negative results in healthy subjects in this study. |
| Provocative dose causing a 20% fall (PD20) | On the 1 day of administration | PD20 is provocative dose causing a 20% fall in forced expiratory volume in 1 second (FEV1) . |
| Adverse events | Base line to 3 days after dosing | adverse events occured after administration |
| heart rate (Vital signs) | Base line to 3 days after dosing | — |
| oxyhemoglobin saturation (Vital signs) | Base line to 3 days after dosing | — |
| Recovery of forced expiratory volume in 1 second (FEV 1) | Base line to 3 days after dosing | Recovery of forced expiratory volume in 1 second (FEV 1) after administration to assess safty profile. |
Countries
China
Contacts
Primary ContactJingping Zheng, Master
Outcome results
None listed