A Study to Evaluate the Sensitivity and Specificity of Inhaled Methacholine in Bronchial Provocation Test
- Registration Number
- NCT05634473
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
A multicenter, open-label study to evaluate the sensitivity and specificity of inhaled methacholine in bronchial provocation test
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 280
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).
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with asthma/healthy subjects Methacholine Chloride -
- Primary Outcome Measures
Name Time Method 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) .
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.
heart rate (Vital signs) Base line to 3 days after dosing Adverse events Base line to 3 days after dosing adverse events occured after administration
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Beijing Chaoyang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Zhejiang Provincial Hospital of Chinese Medicine
🇨🇳Hangzhou, Zhejiang, China
Benxi Central Hospital
🇨🇳Benxi, Liaoning, China
Weifang NO.2 People's Hospital
🇨🇳Weifang, Shandong, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The Affiliated Hospital of Inner Mongolia Medical Univercity
🇨🇳Hohhot, Inner Mongolia, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳WuHan, Hubei, China
Liuzhou people's Hospital
🇨🇳Liuzhou, Guangxi, China
Guangdong Province Hospital of chinese medicine
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
West China Hospital，Sichuan University
🇨🇳ChengDu, Sichuan, China