A Study to Evaluate the Sensitivity and Specificity of Inhaled Methacholine in Bronchial Provocation Test

Asthma Clinical Trial

Official title:

A Multicenter, Open-label Study to Evaluate the Sensitivity and Specificity of Inhaled Methacholine in Bronchial Provocation Test

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05634473
• Other study ID #: TQC3610-CS-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: June 2023

Study information

• Verified date: May 2022
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Jingping Zheng, Master
• Phone: 13560351186
• Email: doctorzcz[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: June 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 (ß2 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.

Related Conditions & MeSH terms

• Asthma
• Hypersensitivity

Intervention

Drug:
• Methacholine Chloride
Cholinergic agonists

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing
China	Benxi Central Hospital	Benxi	Liaoning
China	West China Hospital,Sichuan University	ChengDu	Sichuan
China	Guangdong Province Hospital of chinese medicine	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Zhejiang Provincial Hospital of Chinese Medicine	Hangzhou	Zhejiang
China	The Affiliated Hospital of Inner Mongolia Medical Univercity	Hohhot	Inner Mongolia
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Liuzhou people's Hospital	Liuzhou	Guangxi
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Weifang NO.2 People's Hospital	Weifang	Shandong
China	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	WuHan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity analysis	Sensitivity analysis is percentage of asthmatics subjects with positive final challenge compared with total asthmatics subjects in this study.	On the 1 day of administration
Primary	Specificity Analysis	Specificity is the percentage of healthy subjects with negative results in healthy subjects in this study.	On the 1 day of administration
Primary	Provocative dose causing a 20% fall (PD20)	PD20 is provocative dose causing a 20% fall in forced expiratory volume in 1 second (FEV1) .	On the 1 day of administration
Primary	Adverse events	adverse events occured after administration	Base line to 3 days after dosing
Primary	heart rate (Vital signs)		Base line to 3 days after dosing
Primary	oxyhemoglobin saturation (Vital signs)		Base line to 3 days after dosing
Primary	Recovery of forced expiratory volume in 1 second (FEV 1)	Recovery of forced expiratory volume in 1 second (FEV 1) after administration to assess safty profile.	Base line to 3 days after dosing