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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05922891
Other study ID # D5180R00025
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 27, 2023
Est. completion date September 30, 2025

Study information

Verified date May 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study assesses the impact of tezepelumab treatment not only on asthma control but also on cough specific Health-Related Quality of Life (HRQoL). Asthma control can be evaluated using Asthma Control Questionnaire (ACQ). Cough symptom which is one of the symptoms related airway hyperresponsiveness can be assessed via the relevant questionnaire, Leicester Cough Questionnaire (LCQ). There is moderate negative correlation between ACQ and LCQ . Improvements in both asthma control and cough symptom by tezepelumab would clarify effectiveness of Tezepelumab in real-world. Though Tezepelumab is recently approved in Japan, there is no real-world evidence on tezepelumab, particularly on above mentioned symptoms. Thus, this study aims to estimate effectiveness of tezepelumab on asthma and cough symptoms in real world settings.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date September 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility Inclusion Criteria: 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 Exclusion Criteria: 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Japan Research Site Aomori
Japan Research Site Bunkyo
Japan Research Site Fujisawa
Japan Research Site Fukuoka
Japan Research Site Fukushima
Japan Research Site Hamamatsu
Japan Research Site Hiroshima
Japan Research Site Iizuka
Japan Research Site Itabashi
Japan Research Site Izumo
Japan Research Site Kawasaki
Japan Research Site Kitakyushu
Japan Research Site Kiyose
Japan Research Site Kurashiki
Japan Research Site Matsusaka
Japan Research Site Minami
Japan Research Site Minato
Japan Research Site Minato
Japan Research Site Nagakute
Japan Research Site Nagoya
Japan Research Site Naka
Japan Research Site Niigata
Japan Research Site Nishinomiya
Japan Research Site Osaka
Japan Research Site Osaka
Japan Research Site Sapporo
Japan Research Site Shinagawa
Japan Research Site Shinjuku
Japan Research Site Sizuoka
Japan Research Site Tennoji
Japan Research Site Ube
Japan Research Site Yonago

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change in ACQ-6 at week 52 from baseline To estimate change of asthma control as measured by the ACQ-6 in patients who initiated Tezepelumab at week 52 from baseline Baseline and Week 52
Secondary Mean change in LCQ at week 52 from baseline To estimate change of cough-specific health-related quality of life in patients who initiated Tezepelumab at week 52 from baseline Baseline and Week 52
Secondary Mean change in LCQ at week 4, 12, 24 from baseline To estimate change of cough-specific health-related quality of life in patients who initiated Tezepelumab at week 4, 12, 24 from baseline Baseline, Week 4, Week 12 and Week 24
Secondary Mean change in ACQ-6 at week 4, 12, 24 from baseline To estimate change of asthma control as measured by the ACQ-6 in patients who initiated Tezepelumab at week 4, 12, 24 from baseline Baseline, Week 4, Week 12 and Week 24
Secondary Asthma exacerbation rate during 52 weeks before/after Tezepelumab initiation Ratio of annual asthma exacerbation rate between previous 52 weeks and Tezepelumab treated 52 weeks To estimate asthma exacerbation during 52 weeks before/after Tezepelumab initiation During 52 weeks before/after Tezepelumab initiation
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