AsthmaNCT05634473
A Study to Evaluate the Sensitivity and Specificity of Inhaled Methacholine in Bronchial Provocation Test
A study testing Methacholine Chloride in people with Asthma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 sites in China.
Trial summary
A multicenter, open-label study to evaluate the sensitivity and specificity of inhaled methacholine in bronchial provocation test Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Methacholine Chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 12 sitesChina
- Study dates
- Dec 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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).
Who cannot join
- 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;
Show all 26Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Kewu Huang, Doctor, 13601234681, kewuhuang@126.com
Benxi Central Hospital
Benxi, Liaoning, 117099
xiujuan Geng, Master, 13841483397, gengxiuj2005@163.com
West China Hospital，Sichuan University
Chengdu, Sichuan, 610044
Binmiao Liang, Doctor, 18980606347, liangbinmiao@163.com
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Jingping Zheng, Master, 13560351186, doctorzcz@163.com
Guangdong Province Hospital of chinese medicine
Guangzhou, Guangdong, 510120
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, 310000
Fang Chen, Doctor, 13867130008, funchen@163.com
The Affiliated Hospital of Inner Mongolia Medical Univercity
Hohhot, Inner Mongolia, 10000
Xiuhua Fu, Master, 13947142625, fuxiuhua555@sohu.com
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Xiaoju Liu, Doctor, 13919360884, Liuxiaoju835@126.com
Liuzhou people's Hospital
Liuzhou, Guangxi, 545000
Xuejun Qin, Doctor, 19177226021, 283628789@qq.com
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Wei Zhang, Doctor, 13707089183, zhangwei230218@163.com
Weifang NO.2 People's Hospital
Weifang, Shandong, 261000
Guoru Yang, Bachelor, 13963601993, yangguoru@163.com
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
HuiGuo Liu, Doctor, 13871014148, 13871014148@139.com
About this study
Official title: 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
- Conditions
- Asthma
- Being tested
- Methacholine Chloride
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacholine ChlorideDrug
Cholinergic agonists
| Study group | Role | What they receive |
|---|---|---|
| Patients with asthma/healthy subjects | Experimental | Not described Receives: Drug: Methacholine Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity analysis
Sensitivity analysis is percentage of asthmatics subjects with positive final challenge compared with total asthmatics subjects in this study.
Measured: On the 1 day of administration
Specificity Analysis
Specificity is the percentage of healthy subjects with negative results in healthy subjects in this study.
Measured: 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) .
Measured: On the 1 day of administration
Adverse events
adverse events occured after administration
Measured: Base line to 3 days after dosing
heart rate (Vital signs)
Measured: Base line to 3 days after dosing
oxyhemoglobin saturation (Vital signs)
Measured: 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.
Measured: Base line to 3 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study startDec 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634473
- Sponsor's protocol ID
- TQC3610-CS-01
- Status last verified
- May 2022
- First submitted
- 18 Jul 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study to Evaluate the Sensitivity and Specificity of Inhaled Methacholine in Bronchial Provocation Test
- ClinicalTrials.gov ID
- NCT05634473
- Acronym / sponsor ID
- TQC3610-CS-01
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, open-label study to evaluate the sensitivity and specificity of inhaled methacholine in bronchial provocation test
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with asthma/healthy subjects | Experimental | Drug: Methacholine Chloride |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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;
Key exclusion criteria (26 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methacholine ChlorideCholinergic agonists | Drug | Patients with asthma/healthy subjects |
Primary outcome
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.
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.
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) .
Adverse events
Time frame: Base line to 3 days after dosing
adverse events occured after administration
heart rate (Vital signs)
Time frame: Base line to 3 days after dosing
oxyhemoglobin saturation (Vital signs)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methacholine Chloride in people with Asthma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingping Zheng, Master (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity analysis (time frame: On the 1 day of administration). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.