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

JRCT ID: jRCTs031220218

Registered date:20/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: bronchial asthma
• Date of first enrollment: 08/03/2023
• Target sample size: 12
• Study type: Interventional

Intervention(s)

This study will consist of two dose groups, with the low dose group 1 (5 mg/week) being administered
first to ensure the safety of the study participants. Study participants will be enrolled in Dose Group
2 after enrollment in Dose Group 1 is completed, and Dose Group 2 (15 mg/week) will begin after a
t least one study participant in Dose Group 1 has completed post-testing.

Outcome(s)

• Primary Outcome: Airway hyperresponsiveness test (PC20)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Male

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Hida Noriko
• Source(s) of Monetary Support: TAK-Circulator Corporation