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ClinicalTrials.gov ID

NCT05634473

Lead Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.INDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

280Estimated

Last Update Posted

Dec 2, 2022Actual

Start Date

Dec 2022Estimated

Primary Completion Date

Feb 2023Estimated

Completion Date

Jun 2023Estimated

Official Title

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

Brief Summary

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

• Asthma

• Methacholine Chloride

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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 Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.INDUSTRY

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