JPRN-jRCTs031220218招募中未知
An exploratory study of TAKC-02 in male patients with moderate bronchial asthma
Hida Noriko0 个研究点目标入组 12 人开始时间: 2022年7月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 65age old（—）
- 性别
- Male
入选标准
- •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.
排除标准
- •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 However, drugs to be temporarily withdrawn for airway hypersensitivity testing will be excluded.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
研究者
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