Tezepelumab PRO Study (TezepelumabPRO)

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

Study Overview

• Status: Recruiting
• Conditions: Asthma

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Japan
  • Aomori, Japan
    • Not yet recruiting
    • Research Site
  • Bunkyo, Japan
    • Recruiting
    • Research Site
  • Fujisawa, Japan
    • Not yet recruiting
    • Research Site
  • Fukuoka, Japan
    • Recruiting
    • Research Site
  • Fukushima, Japan
    • Recruiting
    • Research Site
  • Hamamatsu, Japan
    • Recruiting
    • Research Site
  • Hiroshima, Japan
    • Not yet recruiting
    • Research Site
  • Iizuka, Japan
    • Not yet recruiting
    • Research Site
  • Itabashi, Japan
    • Not yet recruiting
    • Research Site
  • Izumo, Japan
    • Recruiting
    • Research Site
  • Kawasaki, Japan
    • Recruiting
    • Research Site
  • Kitakyushu, Japan
    • Recruiting
    • Research Site
  • Kiyose, Japan
    • Recruiting
    • Research Site
  • Kurashiki, Japan
    • Recruiting
    • Research Site
  • Matsusaka, Japan
    • Recruiting
    • Research Site
  • Minami, Japan
    • Recruiting
    • Research Site
  • Minato, Japan
    • Withdrawn
    • Research Site
  • Minato, Japan
    • Recruiting
    • Research Site
  • Nagakute, Japan
    • Withdrawn
    • Research Site
  • Nagoya, Japan
    • Recruiting
    • Research Site
  • Naka, Japan
    • Recruiting
    • Research Site
  • Niigata, Japan
    • Recruiting
    • Research Site
  • Nishinomiya, Japan
    • Recruiting
    • Research Site
  • Osaka, Japan
    • Recruiting
    • Research Site
  • Osaka, Japan
    • Withdrawn
    • Research Site
  • Sapporo, Japan
    • Recruiting
    • Research Site
  • Shinagawa, Japan
    • Not yet recruiting
    • Research Site
  • Shinjuku, Japan
    • Recruiting
    • Research Site
  • Sizuoka, Japan
    • Recruiting
    • Research Site
  • Tennoji, Japan
    • Recruiting
    • Research Site
  • Ube, Japan
    • Recruiting
    • Research Site
  • Yonago, Japan
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: D5180R00025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request will be evaluated as per the AZdisclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No