Clinical trial NCT05634473: A Study to Evaluate the Sensitivity and Specificity of Inhaled Methacholine in Bronchial Provocation Test
Official title: A Multicenter, Open-label Study to Evaluate the Sensitivity and Specificity of Inhaled Methacholine in Bronchial Provocation Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-02
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A multicenter, open-label study to evaluate the sensitivity and specificity of inhaled methacholine in bronchial provocation test


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity analysis
timeFrame: On the 1 day of administration
measure: Specificity Analysis
timeFrame: On the 1 day of administration
measure: Provocative dose causing a 20% fall (PD20)
timeFrame: On the 1 day of administration
measure: Adverse events
timeFrame: Base line to 3 days after dosing
measure: heart rate (Vital signs)
timeFrame: Base line to 3 days after dosing
measure: oxyhemoglobin saturation (Vital signs)
timeFrame: Base line to 3 days after dosing
measure: Recovery of forced expiratory volume in 1 second (FEV 1)
timeFrame: Base line to 3 days after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Province Hospital of chinese medicine
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou people's Hospital
state: Guangxi
city: WuHan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical Univercity
state: Inner Mongolia
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Benxi
country: China
facility: Benxi Central Hospital
state: Liaoning
city: Weifang
country: China
facility: Weifang NO.2 People's Hospital
state: Shandong
city: ChengDu
country: China
facility: West China Hospital，Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of Chinese Medicine
state: Zhejiang
Study officials:
References: