Tezepelumab PRO Study

Active, not recruiting

• Conditions: Asthma

• Registration Number: NCT05922891
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-28
• Study Start: 2023-09-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 92

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in ACQ-6 at week 52 from baseline	Baseline and Week 52	To estimate change of asthma control as measured by the ACQ-6 in patients who initiated Tezepelumab at week 52 from baseline

Secondary Outcome Measures

Name	Time	Method
Mean change in ACQ-6 at week 4, 12, 24 from baseline	Baseline, Week 4, Week 12 and Week 24	To estimate change of asthma control as measured by the ACQ-6 in patients who initiated Tezepelumab at week 4, 12, 24 from baseline
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	To estimate asthma exacerbation during 52 weeks before/after Tezepelumab initiation
Mean change in LCQ at week 52 from baseline	Baseline and Week 52	To estimate change of cough-specific health-related quality of life in patients who initiated Tezepelumab at week 52 from baseline
Mean change in LCQ at week 4, 12, 24 from baseline	Baseline, Week 4, Week 12 and Week 24	To estimate change of cough-specific health-related quality of life in patients who initiated Tezepelumab at week 4, 12, 24 from baseline

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yonago, Japan