Clinical trial NCT05922891: Tezepelumab PRO Study
Official title: Effectiveness of Tezepelumab on Asthma Control and Cough: A Prospective, Multi-center, Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be a total of 90 patients with severe uncontrolled asthma who initiate new prescription of tezepelumab.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in ACQ-6 at week 52 from baseline
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Mean change in LCQ at week 52 from baseline
timeFrame: Baseline and Week 52
measure: Mean change in LCQ at week 4, 12, 24 from baseline
timeFrame: Baseline, Week 4, Week 12 and Week 24
measure: Mean change in ACQ-6 at week 4, 12, 24 from baseline
timeFrame: Baseline, Week 4, Week 12 and Week 24
measure: 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
timeFrame: During 52 weeks before/after Tezepelumab initiation
Other outcomes:
Locations:
city: Aomori
country: Japan
facility: Research Site
city: Bunkyo
country: Japan
facility: Research Site
city: Fujisawa
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Hamamatsu
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Iizuka
country: Japan
facility: Research Site
city: Itabashi
country: Japan
facility: Research Site
city: Izumo
country: Japan
facility: Research Site
city: Kawasaki
country: Japan
facility: Research Site
city: Kitakyushu
country: Japan
facility: Research Site
city: Kiyose
country: Japan
facility: Research Site
city: Kurashiki
country: Japan
facility: Research Site
city: Matsusaka
country: Japan
facility: Research Site
city: Minami
country: Japan
facility: Research Site
city: Minato
country: Japan
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
city: Naka
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Nishinomiya
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Sapporo
country: Japan
facility: Research Site
city: Shinagawa
country: Japan
facility: Research Site
city: Shinjuku
country: Japan
facility: Research Site
city: Sizuoka
country: Japan
facility: Research Site
city: Tennoji
country: Japan
facility: Research Site
city: Ube
country: Japan
facility: Research Site
city: Yonago
country: Japan
facility: Research Site
Study officials:
References: