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NCT Number: NCT05922891

Tezepelumab PRO Study

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aomori, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Mean change in ACQ-6 at week 52 from baseline

    Time frame: 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 outcomes

  1. Mean change in LCQ at week 52 from baseline

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: During 52 weeks before/after Tezepelumab initiation

    To estimate asthma exacerbation during 52 weeks before/after Tezepelumab initiation

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Effectiveness of Tezepelumab on Asthma Control and Cough: A Prospective, Multi-center, Observational Study

Acronym: TezepelumabPRO

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2023
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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