A 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
1 other identifier
interventional
280
1 country
12
Brief Summary
A multicenter, open-label study to evaluate the sensitivity and specificity of inhaled methacholine in bronchial provocation test
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Dec 2022
Shorter than P25 for not_applicable asthma
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedFirst Posted
Study publicly available on registry
December 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedDecember 2, 2022
May 1, 2022
2 months
July 18, 2022
December 1, 2022
Conditions
Outcome Measures
Primary Outcomes (7)
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
Specificity Analysis
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)
PD20 is provocative dose causing a 20% fall in forced expiratory volume in 1 second (FEV1) .
On the 1 day of administration
Adverse events
adverse events occured after administration
Base line to 3 days after dosing
heart rate (Vital signs)
Base line to 3 days after dosing
oxyhemoglobin saturation (Vital signs)
Base line to 3 days after dosing
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
Study Arms (1)
Patients with asthma/healthy subjects
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adults 65 years of age ≥ 18 years of age, male or female;
- Normal or abnormal pulmonary function test without clinical significance (FEV1 ≥ 70% predicted);
- Voluntary, signed informed consent, good compliance, can cooperate with the trial observation.
- Patients with asthma:
- Clinical diagnosis of asthma patients;
- 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:
- 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).
You may not qualify if:
- Patients with any of the following criteria will not be included in the trial:
- Patients with a past history of allergy to this type of reagent;
- Patients with a history of heart disease who are difficult to adapt to bronchial provocation test;
- Patients who have undergone thoracic or abdominal surgery within 6 months before the trial;
- Patients who have undergone surgery for intracranial, ophthalmic diseases, ear, nose and throat diseases, and respiratory diseases 6 months before the trial;
- Complicated pneumothorax and other respiratory diseases or tuberculosis and other infectious diseases;
- 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.);
- Patients with a past history of drug dependence or alcohol dependence;
- 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.;
- Patients who are using cholinase inhibitors (treatment of myasthenia gravis);
- Patients with unexplained urticaria;
- Pregnant and lactating women;
- Subjects with dyspnea, wheezing, wheezing on the day of the trial;
- Patients with myocardial infarction or stroke, combined with hypertension (systolic blood pressure \> 200 mmHg, diastolic blood pressure \> 100 mmHg);
- Poor cooperation in basic pulmonary function tests, not in line with quality control;
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
Guangdong Province Hospital of chinese medicine
Guangzhou, Guangdong, 510120, China
Liuzhou people's Hospital
Liuchow, Guangxi, 545000, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
The Affiliated Hospital of Inner Mongolia Medical Univercity
Hohhot, Inner Mongolia, 10000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Benxi Central Hospital
Benxi, Liaoning, 117099, China
Weifang NO.2 People's Hospital
Weifang, Shandong, 261000, China
West China Hospital，Sichuan University
Chengdu, Sichuan, 610044, China
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2022
First Posted
December 2, 2022
Study Start
December 1, 2022
Primary Completion
February 1, 2023
Study Completion
June 1, 2023
Last Updated
December 2, 2022
Record last verified: 2022-05