AsthmaPhase 4NCT06725641
Bioequivalence Study of Methacholine for Inhalation (pharmacodynamics)
A Phase 4 study testing Test preparation：Methylcholine chloroacetate for inhalation and Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine） in people with Asthma, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This trial was divided into two parts. This is the scecond part. The second part is the pharmacodynamic equivalence study of patients, which is a single-dose, randomized, open, two-cycle, two-sequence crossover design, and plans to enroll 40 subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Test preparation：Methylcholine chloroacetate for inhalation and Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2024to 26 Oct 2024
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults 18 years old ≤ age ≤65 years old, gender is not limited.
- Lung function test FEV1≥70% of the predicted value, and FEV1/FVC≥0.7. 3. Patients with clinically diagnosed asthma or others willing to accept bronchial stimulation test.
- 4. Patients who use contraindicated drugs (β2 adrenergic receptor agonists, anticholinergics, oral bronchodilators, antihistamines, leukotriene receptor antagonists) may be discontinued during the prescribed period prior to airway reactivity examination.
- 5, voluntary enrollment, signed informed consent, compliance is good, can cooperate with the test observation.
Who cannot join
- there is a history of allergy to this reagent.
- Patients with a history of heart disease who have difficulty tolerating bronchial provocation tests.
- Patients who had received thoracic or abdominal surgery within 6 months before the trial.
- Patients who had undergone surgery for intracranial, eye, ear, nose and throat, and respiratory diseases within 6 months before the trial.
- Patients with respiratory diseases such as pneumothorax or infectious diseases such as tuberculosis.
- Patients with diseases that may be affected by the use of cholinergic drugs (epilepsy, bradycardia, coronary artery occlusion, vagus nerve tension, thyroid disease, arrhythmia, peptic ulcer, urinary tract disorders, etc.).
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- Patients with a history of drug dependence or alcohol dependence.
- Severe circulatory system diseases, liver and bile system diseases, digestive tract diseases, urinary system diseases, kidney diseases, blood diseases, endocrine system diseases, immune system diseases, malignant tumors, etc.
- Patients who are taking cholinase inhibitors (for myasthenia gravis).
- Patients with unexplained urticaria.
- Pregnant and lactating women.
- The subjects had dyspnea, wheezing or wheezing on the test day.
- have myocardial infarction or stroke, combined with hypertension (systolic blood pressure >200mmHg, diastolic blood pressure >100mmHg) patients.
- Poor coordination of basic lung function examination and failure to meet quality control.
- Patients who have used drugs that affect airway contractile function and airway inflammation before the trial and can not be stopped (bronchodilators, glucocorticoids, antiallergens and triene receptor antagonists, etc.).
- Current smokers, those who had quit smoking for less than one year at the time of screening, and those who had a smoking history of more than 10 pack-years.
- Patients admitted to hospital for exacerbation of asthma within 12 weeks.
- combined with patients with respiratory diseases (such as COPD) that may affect the efficacy and safety evaluation of the drug.
- Researchers believe that there are any cases that are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
China-japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Bioequivalence Study of Methacholine for Inhalation
This trial was divided into two parts. This is the scecond part. The second part is the pharmacodynamic equivalence study of patients, which is a single-dose, randomized, open, two-cycle, two-sequence crossover design, and plans to enroll 40 subjects.
- Conditions
- Asthma
- Being tested
- Test preparation：Methylcholine chloroacetate for inhalation, Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）
- Keywords
- Clinically diagnosed asthma patients or other individuals willing to undergo bronchial provocation tests.
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test preparation：Methylcholine chloroacetate for inhalationDrug
Cholinergic agonists
Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）Drug
Cholinergic agonists
| Study group | Role | What they receive |
|---|---|---|
| Test preparation：Methylcholine chloroacetate for inhalation | Experimental | Inhale different concentrations of choline chloride solution Receives: Drug: Test preparation：Methylcholine chloroacetate for inhalation |
| Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine） | Active comparator | Inhale different concentrations of choline chloride solution Receives: Drug: Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative dose of inhaled activator with a 20% reduction in forced expiratory volume in the first second from baseline
Cumulative dose of inhaled activator with a 20% reduction in forced expiratory volume in the first second from baseline
Measured: 30 to 90 seconds after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start24 Feb 2024
- Primary completion22 Oct 2024
- Study completion26 Oct 2024
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 China-Japan Friendship HospitalThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Principal investigator, Ting YANG, China-Japan Friendship Hospital
- Investigators
- Ting Yang, Doctor, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725641
- Sponsor's protocol ID
- TQC3610-BE-01(PD)
- Status last verified
- Dec 2024
- First submitted
- 30 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Methacholine for Inhalation
- ClinicalTrials.gov ID
- NCT06725641
- Acronym / sponsor ID
- TQC3610-BE-01(PD)
- Conditions
- Asthma
- Keywords
- Clinically diagnosed asthma patients or other individuals willing to undergo bronchial provocation tests.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 26 Oct 2024 (actual)
- First posted
- 10 Dec 2024 (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.
This trial was divided into two parts. This is the scecond part. The second part is the pharmacodynamic equivalence study of patients, which is a single-dose, randomized, open, two-cycle, two-sequence crossover design, and plans to enroll 40 subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test preparation：Methylcholine chloroacetate for inhalation | Experimental | Drug: Test preparation：Methylcholine chloroacetate for inhalationInhale different concentrations of choline chloride solution |
| Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine） | Active comparator | Drug: Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）Inhale different concentrations of choline chloride solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults 18 years old ≤ age ≤65 years old, gender is not limited.
- Lung function test FEV1≥70% of the predicted value, and FEV1/FVC≥0.7. 3. Patients with clinically diagnosed asthma or others willing to accept bronchial stimulation test.
- 4. Patients who use contraindicated drugs (β2 adrenergic receptor agonists, anticholinergics, oral bronchodilators, antihistamines, leukotriene receptor antagonists) may be discontinued during the prescribed period prior to airway reactivity examination.
- 5, voluntary enrollment, signed informed consent, compliance is good, can cooperate with the test observation.
Key exclusion criteria (19 listed)
- there is a history of allergy to this reagent.
- Patients with a history of heart disease who have difficulty tolerating bronchial provocation tests.
- Patients who had received thoracic or abdominal surgery within 6 months before the trial.
- Patients who had undergone surgery for intracranial, eye, ear, nose and throat, and respiratory diseases within 6 months before the trial.
- Patients with respiratory diseases such as pneumothorax or infectious diseases such as tuberculosis.
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 |
|---|---|---|
| Test preparation：Methylcholine chloroacetate for inhalationCholinergic agonists | Drug | Test preparation：Methylcholine chloroacetate for inhalation |
| Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）Cholinergic agonists | Drug | Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine） |
Primary outcome
Cumulative dose of inhaled activator with a 20% reduction in forced expiratory volume in the first second from baseline
Time frame: 30 to 90 seconds after administration
Cumulative dose of inhaled activator with a 20% reduction in forced expiratory volume in the first second from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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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.
Ting Yang, Doctor principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Test preparation：Methylcholine chloroacetate for inhalation and Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine） in people with Asthma, run by China-Japan Friendship Hospital at 1 site 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 4 inclusion and 19 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: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative dose of inhaled activator with a 20% reduction in forced expiratory volume in the first second from baseline (time frame: 30 to 90 seconds after administration). 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 10 Dec 2024.