Effectiveness of Tezepelumab on Asthma control and Cough: A prospective, multi-center, observational study - Tezepelumab PRO study

Tashiro Naoki0 个研究点目标入组 90 人开始时间: 2023年8月5日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•1. Patients aged >=18 years who provide informed consent and who receive new prescription of Tezepelumab as per the physician's decision at baseline according to the package insert saying Tezepelumab is given to patient with asthma (limited to severe or refractory patient whose asthma symptoms cannot be controlled even with existing treatment)
•2. ACQ-6 >=1.5 at baseline
•3. Patients with persistent cough >=8 weeks up until the baseline visit according to The Japanese Respiratory Society Guidelines for the Management of Cough and Sputum 2019

•1. Patients who had asthma exacerbation within one month before study enrollment
•2. Patients who had the biologics treatment in following period prior to the enrollment
•-omalizumab in 2 or 4 weeks depending on the body weight and total IgE amount
•-mepolizumab in 4 weeks
•-Benralizumab in 8 weeks
•-Dupilumab in 2 weeks
•3. Patients with cough related diseases other than asthma as determined by treating physicians
•4. Patients participating in studies that affect this study (study with other interventional treatment to evaluate efficacy/safety of treatment in patients with cough, asthma, or allergic/eosinophilic diseases)
•5. Any disorder, including heart failure, malignancy, morbid obesity(BMI>=35) , respiratory infectious disease that is not stable (e.g. patients who need medical treatment) in the opinion of the investigator and could:
•- Affect the safety of the patient throughout the study
•- Impede the patient's ability to complete the entire duration of study
•6. Patients with pregnancy or lactation period

发起方

Tashiro Naoki