Tezepelumab PRO Study
TezepelumabPRO
Effectiveness of Tezepelumab on Asthma Control and Cough: A Prospective, Multi-center, Observational Study
1 other identifier
observational
92
1 country
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2023
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2023
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedStudy Start
First participant enrolled
September 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2025
CompletedSeptember 30, 2025
September 1, 2025
2 years
June 20, 2023
September 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Mean change in LCQ at week 52 from baseline
Baseline and Week 52
Mean change in LCQ at week 4, 12, 24 from baseline
Baseline, Week 4, Week 12 and Week 24
Mean change in ACQ-6 at week 4, 12, 24 from baseline
Baseline, Week 4, Week 12 and Week 24
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
During 52 weeks before/after Tezepelumab initiation
Eligibility Criteria
The study population will be a total of 90 patients with severe uncontrolled asthma who initiate new prescription of tezepelumab.
You may qualify if:
- 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
You may not qualify if:
- 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
- Impede the patient's ability to complete the entire duration of study
- Patients with pregnancy or lactation period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (29)
Research Site
Aomori, Japan
Research Site
Bunkyō City, 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
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
Nagoya, Japan
Research Site
Naka, Japan
Research Site
Niigata, Japan
Research Site
Nishinomiya, Japan
Research Site
Osaka, Japan
Research Site
Sapporo, Japan
Research Site
Shinagawa City, Japan
Research Site
Shinjuku, Japan
Research Site
Shizuoka, Japan
Research Site
tabashi City, Japan
Research Site
Tennōjichō-kita, Japan
Research Site
Ube, Japan
Research Site
Yonago, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2023
First Posted
June 28, 2023
Study Start
September 27, 2023
Primary Completion
September 20, 2025
Study Completion
September 20, 2025
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request will be evaluated as per the AZdisclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.