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

JRCT ID: jRCT1030230280

Registered date:05/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: asthma
• Date of first enrollment: 27/09/2023
• Target sample size: 90
• Study type: Observational

Outcome(s)

• Primary Outcome: Mean change in ACQ-6 at week 52 from baseline

Secondary Outcome

Key secondary Outcome measure:
Mean change in LCQ at week 52 from baseline
Secondary Outcome measure:
1. Mean change in LCQ at week 4,12,24 from baseline
2. Mean change in ACQ-6 at week 4,12,24 from baseline
3. 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tashiro Naoki
• Source(s) of Monetary Support: AstraZeneca K.K.
• Secondary ID(s): NCT05922891