Bioequivalence Study of Methacholine for Inhalation (pharmacodynamics)

NCT06725641 | Completed Phase 4

• 1 other identifier: TQC3610-BE-01(PD)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test preparation：Methylcholine chloroacetate for inhalation

EXPERIMENTAL

Inhale different concentrations of choline chloride solution

Drug: Test preparation：Methylcholine chloroacetate for inhalation

Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）

ACTIVE COMPARATOR

Inhale different concentrations of choline chloride solution

Drug: Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）

Interventions

Test preparation：Methylcholine chloroacetate for inhalation DRUG

Cholinergic agonists

Test preparation：Methylcholine chloroacetate for inhalation

Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine） DRUG

Cholinergic agonists

Reference preparation：Methylcholine chloroacetate for inhalation（Provocholine）

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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.
• , voluntary enrollment, signed informed consent, compliance is good, can cooperate with the test observation.

You may not qualify if:

• 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.).
• 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.).

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

China-japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Asthma

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Ting Yang, Doctor

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: December 10, 2024
• Study Start: February 24, 2024
• Primary Completion: October 22, 2024
• Study Completion: October 26, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CN (1)