An exploratory study of TAKC-02 in male patients with moderate bronchial asthma

Not Applicable

Recruiting

• Conditions: bronchial asthma; D001249

• Registration Number: JPRN-jRCTs031220218
• Lead Sponsor: Hida Noriko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-20
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

1) Age: 18 to 65 years old at the time of obtaining consent
2) Gender: Male
3) Moderate bronchial asthma patients
4) Patients with an asthma control test (ACT) score of less than 20
5) Non-smokers or those who have been smoke-free for more than one year and have a history of smoking (one pack per day, within 10 years)
6) Persons who are capable of consenting, who will observe the compliance rules during research
participation, who will undergo the preliminary examination specified in this research protocol, and who will be able to report subjective symptoms, etc.
7) Those who have been judged eligible to participate in this study by the principal investigator or sub-investigator in the preliminary examination specified in this research protocol.

Exclusion Criteria

1) Those who have a positive test for COVID-19 antigen on the screening test date.
2) Patients with signs of infection on the screeningtest date
3) Patients with a PC20 of 10 mg/mL or higher on the acetylcholine airway hyperresponsiveness test
4) Patients with difficulty in sputum evacuation
5) Patients with dyspnea or wheezing at the time of airway hypersensitivity test
6) Persons who are scheduled to change or have changed the dosage and administration of bronchial asthma medication being taken at the time of obtaining consent from the time of obtaining consent until the end of the post-test. However, drugs to be temporarily withdrawn for airway hypersensitivity testing will be excluded.
7) Patients who are unwilling to comply with adequate contraception using an effective method of birth control during the period from the date of the first dose of this study drug to 3 weeks after the last dose.
8) Patients with concomitant diseases affected bycholinergic administration (epilepsy, bradycardia, coronary artery occlusion, vagal tone, thyroid disease, arrhythmia, peptic ulcer, urinary tract disorder, etc.)
9) Patients with hypersensitivity diseases (except for hay fever patients who do not show symptoms)
10) Persons with a history of drug allergy
11) Persons who have been hospitalized due to asthma exacerbation within 12 weeks prior to the date of consent
12) Patients who participated in other clinical studies and received medication within 16 weeks prior to the administration of study drug, or who will participate in other clinical studies at the same time as this research study
13) Patients who have undergone surgical treatment of the chest or abdomen within 6 months prior to the date of consent.
14) Patients who are taking biological agents forthe treatment of bronchial asthma
15) Patients who are taking warfarin.
16) Others who are judged by the principal investigator or sub-investigator to be ineligible to participate in the study as subjects of this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Airway hyperresponsiveness test (PC20)

Secondary Outcome Measures

Name	Time	Method
Respiratory function tests (FVC, %VC, FEV1, %FEV1)<br>Peak flow (morning and evening)<br>Cytokines in sputum (IL-1beta, IL-17A, IL-4, IL-6, IL-8, IFN-gamma, TNF-alpha)