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

Primary Purpose

Asthma

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Methacholine Chloride
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Beijing Chaoyang Hospital, Capital Medical University
  • The First Hospital of Lanzhou University
  • The First Affiliated Hospital of Guangzhou Medical University
  • Guangdong Province Hospital of chinese medicine
  • Liuzhou people's Hospital
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • The Affiliated Hospital of Inner Mongolia Medical Univercity
  • The First Affiliated Hospital of Nanchang University
  • Benxi Central Hospital
  • Weifang NO.2 People's Hospital
  • West China Hospital,Sichuan University
  • Zhejiang Provincial Hospital of Chinese Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with asthma/healthy subjects

Arm Description

Outcomes

Primary Outcome Measures

Sensitivity analysis
Sensitivity analysis is percentage of asthmatics subjects with positive final challenge compared with total asthmatics subjects in this study.
Specificity Analysis
Specificity is the percentage of healthy subjects with negative results in healthy subjects in this study.
Provocative dose causing a 20% fall (PD20)
PD20 is provocative dose causing a 20% fall in forced expiratory volume in 1 second (FEV1) .
Adverse events
adverse events occured after administration
heart rate (Vital signs)
oxyhemoglobin saturation (Vital signs)
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.

Secondary Outcome Measures

Full Information

First Posted
July 18, 2022
Last Updated
December 1, 2022
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05634473
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with asthma/healthy subjects
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methacholine Chloride
Intervention Description
Cholinergic agonists
Primary Outcome Measure Information:
Title
Sensitivity analysis
Description
Sensitivity analysis is percentage of asthmatics subjects with positive final challenge compared with total asthmatics subjects in this study.
Time Frame
On the 1 day of administration
Title
Specificity Analysis
Description
Specificity is the percentage of healthy subjects with negative results in healthy subjects in this study.
Time Frame
On the 1 day of administration
Title
Provocative dose causing a 20% fall (PD20)
Description
PD20 is provocative dose causing a 20% fall in forced expiratory volume in 1 second (FEV1) .
Time Frame
On the 1 day of administration
Title
Adverse events
Description
adverse events occured after administration
Time Frame
Base line to 3 days after dosing
Title
heart rate (Vital signs)
Time Frame
Base line to 3 days after dosing
Title
oxyhemoglobin saturation (Vital signs)
Time Frame
Base line to 3 days after dosing
Title
Recovery of forced expiratory volume in 1 second (FEV 1)
Description
Recovery of forced expiratory volume in 1 second (FEV 1) after administration to assess safty profile.
Time Frame
Base line to 3 days after dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingping Zheng, Master
Phone
13560351186
Email
doctorzcz@163.com
Facility Information:
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kewu Huang, Doctor
Phone
13601234681
Email
kewuhuang@126.com
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoju Liu, Doctor
Phone
13919360884
Email
Liuxiaoju835@126.com
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingping Zheng, Master
Phone
13560351186
Email
doctorzcz@163.com
Facility Name
Guangdong Province Hospital of chinese medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Liuzhou people's Hospital
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuejun Qin, Doctor
Phone
19177226021
Email
283628789@qq.com
Facility Name
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
WuHan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HuiGuo Liu, Doctor
Phone
13871014148
Email
13871014148@139.com
Facility Name
The Affiliated Hospital of Inner Mongolia Medical Univercity
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
10000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuhua Fu, Master
Phone
13947142625
Email
fuxiuhua555@sohu.com
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Doctor
Phone
13707089183
Email
zhangwei230218@163.com
Facility Name
Benxi Central Hospital
City
Benxi
State/Province
Liaoning
ZIP/Postal Code
117099
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiujuan Geng, Master
Phone
13841483397
Email
gengxiuj2005@163.com
Facility Name
Weifang NO.2 People's Hospital
City
Weifang
State/Province
Shandong
ZIP/Postal Code
261000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoru Yang, Bachelor
Phone
13963601993
Email
yangguoru@163.com
Facility Name
West China Hospital,Sichuan University
City
ChengDu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binmiao Liang, Doctor
Phone
18980606347
Email
liangbinmiao@163.com
Facility Name
Zhejiang Provincial Hospital of Chinese Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Chen, Doctor
Phone
13867130008
Email
funchen@163.com

12. IPD Sharing Statement

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

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