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

December 1, 2022 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • The First Hospital of Lanzhou University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510120
        • Guangdong Province Hospital of Chinese Medicine
    • Guangxi
      • Liuzhou, Guangxi, China, 545000
        • Liuzhou People's Hospital
        • Contact:
    • Hubei
      • WuHan, Hubei, China, 430030
        • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 10000
        • The Affiliated Hospital of Inner Mongolia Medical Univercity
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
        • Contact:
    • Liaoning
      • Benxi, Liaoning, China, 117099
        • Benxi Central Hospital
        • Contact:
    • Shandong
      • Weifang, Shandong, China, 261000
        • Weifang NO.2 people's Hospital
        • Contact:
    • Sichuan
      • ChengDu, Sichuan, China, 610044
        • West China Hospital,Sichuan University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Zhejiang Provincial Hospital of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with asthma/healthy subjects
Drug: Methacholine Chloride
Cholinergic agonists

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

July 18, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQC3610-CS-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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