Bioequivalence Study of Methacholine for Inhalation (pharmacodynamics)

NCT ID: NCT06725641

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-24
• Study Completion Date: 2024-10-26

Brief 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.

Conditions

Asthma

Keywords

Clinically diagnosed asthma patients or other individuals willing to undergo bronchial provocation tests.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Test preparation：Methylcholine chloroacetate for inhalation

Inhale different concentrations of choline chloride solution

Group Type: EXPERIMENTAL

Test preparation：Methylcholine chloroacetate for inhalation

Intervention Type: DRUG

Cholinergic agonists

Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）

Inhale different concentrations of choline chloride solution

Group Type: ACTIVE_COMPARATOR

Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）

Intervention Type: DRUG

Cholinergic agonists

Interventions

Test preparation：Methylcholine chloroacetate for inhalation

Cholinergic agonists

Intervention Type: DRUG

Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）

Cholinergic agonists

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. adults 18 years old ≤ age ≤65 years old, gender is not limited.

2. 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.

Exclusion Criteria

1. there is a history of allergy to this reagent.

2. Patients with a history of heart disease who have difficulty tolerating bronchial provocation tests.

3. Patients who had received thoracic or abdominal surgery within 6 months before the trial.

4. Patients who had undergone surgery for intracranial, eye, ear, nose and throat, and respiratory diseases within 6 months before the trial.

5. Patients with respiratory diseases such as pneumothorax or infectious diseases such as tuberculosis.

6. 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.).

7. Patients with a history of drug dependence or alcohol dependence.

8. 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.

9. Patients who are taking cholinase inhibitors (for myasthenia gravis).

10. Patients with unexplained urticaria.

11. Pregnant and lactating women.

12. The subjects had dyspnea, wheezing or wheezing on the test day.

13. have myocardial infarction or stroke, combined with hypertension (systolic blood pressure >200mmHg, diastolic blood pressure >100mmHg) patients.

14. Poor coordination of basic lung function examination and failure to meet quality control.

15. 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.).

16. 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.

17. Patients admitted to hospital for exacerbation of asthma within 12 weeks.

18. combined with patients with respiratory diseases (such as COPD) that may affect the efficacy and safety evaluation of the drug.

19. Researchers believe that there are any cases that are not suitable for inclusion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ting YANG

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ting Yang, Doctor

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

China-japan Friendship Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

TQC3610-BE-01(PD)

Identifier Type: -

Identifier Source: org_study_id