Bioequivalence Study of Methacholine for Inhalation (pharmacodynamics)

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Test preparation：Methylcholine chloroacetate for inhalation; Drug: Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test preparation：Methylcholine chloroacetate for inhalation; Inhale different concentrations of choline chloride solution	Drug: Test preparation：Methylcholine chloroacetate for inhalation; Cholinergic agonists
Active Comparator: Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）; Inhale different concentrations of choline chloride solution	Drug: Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）; Cholinergic agonists

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 to 90 seconds after administration

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Investigators: Principal Investigator: Ting Yang, Doctor, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2024
• Primary Completion (Actual): October 22, 2024
• Study Completion (Actual): October 26, 2024

Study Registration Dates

• First Submitted: November 30, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 8, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Clinically diagnosed asthma patients or other individuals willing to undergo bronchial provocation tests.
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Respiratory Aspiration; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Antimetabolites; Neurotransmitter Agents; Respiratory System Agents; Cholinergic Agents; Nootropic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Cholinergic Agonists; Parasympathomimetics; Muscarinic Agonists; Lipotropic Agents; Miotics; Bronchoconstrictor Agents; Choline; Methacholine Chloride
• Other Study ID Numbers: TQC3610-BE-01(PD)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No