AsthmaTezepelumabPRONCT05922891
Tezepelumab PRO Study
An observational study of Asthma, run by AstraZeneca at 29 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Asthma
- How many people
- 92 participants
- Where
- 29 sitesJapan
- Study dates
- 27 Sep 2023to 20 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be a total of 90 patients with severe uncontrolled asthma who initiate new prescription of tezepelumab.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Japan29 sites
Research Site
Aomori
Research Site
Bunkyō City
Research Site
Fujisawa
Research Site
Fukuoka
Research Site
Fukushima
Research Site
Hamamatsu
Research Site
Hiroshima
Research Site
Iizuka
Research Site
Izumo
Research Site
Kawasaki
Research Site
Kitakyushu
Research Site
Kiyose
Research Site
Kurashiki
Research Site
Matsusaka
Research Site
Minami
Research Site
Minato
Research Site
Nagoya
Research Site
Naka
Research Site
Niigata
Research Site
Nishinomiya
Research Site
Osaka
Research Site
Sapporo
Research Site
Shinagawa City
Research Site
Shinjuku
Research Site
Shizuoka
Research Site
tabashi City
Research Site
Tennōjichō-kita
Research Site
Ube
Research Site
Yonago
About this study
Official title: 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.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Week 52
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: During 52 weeks before/after Tezepelumab initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start27 Sep 2023
- Primary completion20 Sep 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922891
- Sponsor's protocol ID
- D5180R00025
- Acronym
- TezepelumabPRO
- Status last verified
- Aug 2026
- First submitted
- 20 Jun 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tezepelumab on Asthma Control and Cough: A Prospective, Multi-center, Observational Study
- ClinicalTrials.gov ID
- NCT05922891
- Acronym / sponsor ID
- TezepelumabPRO / D5180R00025
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be a total of 90 patients with severe uncontrolled asthma who initiate new prescription of tezepelumab.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- Patients who had asthma exacerbation within one month before study enrollment
- Patients who had the biologics treatment in following period prior to the enrollment
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Mean change in LCQ at week 52 from baseline
Time frame: Baseline and Week 52
Mean change in LCQ at week 4, 12, 24 from baseline
Time frame: Baseline, Week 4, Week 12 and Week 24
Mean change in ACQ-6 at week 4, 12, 24 from baseline
Time frame: 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
Time frame: During 52 weeks before/after Tezepelumab initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- D5180R00025\_CSR synopsis\_redactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 29 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in ACQ-6 at week 52 from baseline (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.