jRCT1030230280
Active, not recruiting
Not Applicable
Effectiveness of Tezepelumab on Asthma control and Cough: A prospective, multi-center, observational study (Tezepelumab PRO study)
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca K.K.
- Enrollment
- 90
- Primary Endpoint
- -
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •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)"
- •ACQ-6 >=1.5 at baseline
- •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
Exclusion Criteria
- •Patients who had asthma exacerbation within one month before study enrollment
- •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
- •Patients with cough related diseases other than asthma as determined by treating physicians
- •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)
- •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
Outcomes
Primary Outcomes
-
Mean change in ACQ-6 at week 52 from baseline
Secondary Outcomes
No secondary outcomes reported
Investigators
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