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TezepelumabPRO: Tezepelumab PRO Study

Sponsor
AstraZeneca (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05922891
Collaborator
(none)
90
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effectiveness of Tezepelumab on Asthma Control and Cough: A Prospective, Multi-center, Observational Study
    Anticipated Study Start Date :
    Sep 29, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2025
    Anticipated Study Completion Date :
    Sep 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 130 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Patients with cough related diseases other than asthma as determined by treating physicians

    2. 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)

    3. 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

    1. Patients with pregnancy or lactation period

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT05922891
    Other Study ID Numbers:
    • D5180R00025
    First Posted:
    Jun 28, 2023
    Last Update Posted:
    Jun 28, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Jun 28, 2023