AsthmaEVOLVENCT06724575
EVOLVE Study: The Real-life Clinical Practice With Tezepelumab in Greece
An observational study of Asthma, run by AstraZeneca at 8 sites in Greece.
Trial summary
Tezepelumab is a first-in-class human monoclonal antibody for uncontrolled severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), a key epithelial cytokine inducing both Type 2 and non- Type 2 inflammatory pathways. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- How many people
- 156 participants
- Where
- 8 sitesGreece
- Study dates
- 17 Dec 2024to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population from private practices and hospital clinics specializing in the management of Severe Asthma, in geographically diverse locations throughout Greece, with a balanced representation of public, academic and private sector in Greece.
Who may be able to join
- Male or female outpatients aged 12 years or older at the time of signing the informed consent/assent form.
- Patients who have been prescribed but not yet initiated treatment with tezepelumab according to the label and local market reimbursement criteria.
- Diagnosis of asthma for at least 52 weeks prior to enrolment date and symptoms confirmed by the Investigator not to be due to alternative diagnoses.
- Receipt of at least one prescription of high-dose Inhaled Corticosteroids (ICS) (according to the Global Initiative for Asthma 2024) during the 52 weeks prior to enrolment date.
- Use of additional asthma maintenance controller medication(s) in addition to ICS either as free- or fixed-drug combination for at least 52 weeks prior to enrolment date.
- Documented history of at least 1 asthma exacerbation during the 52 weeks prior to enrolment date.
Show all 11Show fewer
- Asthma Control Questionnaire (ACQ-6) score ≥1.5 (indicating inadequate asthma symptom control) at enrolment.
- Availability of at least one Blood Eosinophil Count (BEC) measurement (in medical records) in the 52-week period prior to enrolment date.
- Availability of participants' medical records for asthma exacerbations and unscheduled Health Care Resource Utilization (HCRU) for the 52 weeks prior to enrolment date.
- Patients are able to understand and complete the Patient-Reported Outcome (PROs).
- Provision of signed and dated written informed consent/assent (as applicable).
Who cannot join
- Any contraindication to tezepelumab as per the approved product label or in the opinion of the Investigator.
- Concurrent or recent (<30 days before the index date) treatment with biologics for asthma, with the exception of stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment).
- Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months.
- Currently pregnant (or intention to become pregnant) or lactating women.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Greece8 sites
Research Site
Alexandroupoli
Research Site
Athens
Research Site
Corfu
Research Site
Crete
Research Site
Ioannina
Research Site
Larissa
Research Site
Pátrai
Research Site
Thessaloniki
About this study
Official title: The EVOLVE Study: A Prospective, Observational Study to Evaluate Patient-centered Outcomes Over 2 Years of Treatment With Tezepelumab in Real-life Clinical Practice in Greece
Tezepelumab is a first-in-class human monoclonal antibody for uncontrolled severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), a key epithelial cytokine inducing both Type 2 and non- Type 2 inflammatory pathways. Considering the recent addition of tezepelumab to the severe asthma therapeutic arsenal, there is a need for real-world evidence that can inform treatment-decision making in clinical practice and support regulatory decisions.
EVOLVE is a prospective, observational study designed to generate real-world evidence on patient-reported outcomes of treatment with tezepelumab, assessing the effectiveness over a 2-year period in routine care settings in Greece.
Read more
The study plans to enroll 150 adult patients at an allocation ratio of: i) 70 percent Type 2-high/30 percent Type 2-low, and ii) 80 percent biologic naïve/20 percent switching from a prior biologic. Eligible patients must be newly prescribed tezepelumab according to the approved label.
Primary data will be collected at enrollment and 4, 12, 24, 52, 72 and 104 weeks after treatment initiation through visits as per the standard clinical practice in various healthcare settings (20-25 sites) across the country.
The primary objective is to describe the patient-reported asthma symptom control using the Asthma Control Questionnaire (ACQ-6) at baseline and up to 104 weeks post-index. Secondary and exploratory objectives include assessment of quality of life, lung function, exacerbation rate, corticosteroid use, health-care utilization. Novel composite endpoints will also be evaluated such as early clinically important improvement, disease stability, super-response and clinical remission at 2 years, which in the era of precision biologics, have the potential to shift treatment paradigms toward a treat-to-target approach.
Findings of EVOLVE are expected to not only complement evidence obtained from clinical trials, but also to provide valuable insights into the long-term durability of treatment benefits and sustainability of clinical response under pragmatic clinical conditions.
- Conditions
- Asthma
- Keywords
- severe asthma, tezepelumab, real world data, patient reported outcomes, Greece
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the ACQ-6 score at baseline and up to 104 weeks post-index
Asthma Control Questionnaire-6 (ACQ-6) score at different timepoints Change in ACQ-6 score from baseline Proportion of patients with ACQ-6 response (i.e., achieving the Minimum Clinically Important Difference (MCID) of ≥0.5 reduction in score from baseline) Proportion of patients with major improvement in asthma control (defined as decrease in ACQ-6 score ≥1 point [i.e., 2xMCID] from baseline) Proportion of patients with well-controlled asthma (ACQ-6 score ≤ 0.75) Proportion of patients with ACQ-6 score in categories 0.75 to <1.5 and ≥1.5 Time to ACQ-6 score response
Measured: Before treatment initiation and at Weeks 4, 12, 24, 52, 72, 104 after treatment initiation
Secondary outcomes (15)
Change in asthma-specific HRQoL using the SGRQ at baseline and up to 52 weeks post-index
St. George's Respiratory Questionnaire (SGRQ) total and component scores at different timepoints Change in SGRQ total and component scores from baseline Proportion of patients with SGRQ response (≥4-point reduction in total score from baseline)
Measured: Before treatment initiation and at Weeks 24 and 52 after treatment initiation
Change in FEV1 (forced expiratory volume in 1 second) at baseline and up to 104 weeks post-index
To describe the pre- and post-BD (Bronchodilation) FEV1, as well as the changes from baseline in pre- and post-BD FEV1 in patients receiving Tezepelumab.
Measured: Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
Change in FVC (Forced Vital Capacity) at baseline and up to 104 weeks post-index
To describe the pre- and post-BD (Bronchodilation) FVC, as well as the changes from baseline in pre- and post-BD FVC in patients receiving Tezepelumab.
Measured: Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
Change in pre-BD FEF25-75 (Forced Expiratory Flow) at baseline and up to 104 weeks post-index
To assess the pre-BD (Bronchodilation) FEF25-75, as well as the changes from baseline in pre-BD FEF25-75 in patients receiving Tezepelumab
Measured: Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
Change in lung function at baseline and up to 104 weeks post-index
To evaluate the proportion of pre- and post-BD (Bronchodilation) FEV1 responders (≥5 percent or ≥100 mL improvement from baseline)
Measured: Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
Change in asthma exacerbations in the 52 and 104 weeks post-index
To describe (a) Annualised Asthma Exacerbation Rate (AAER), (b) change in AAER from the 52 week period pre-index to the 52- and 104- week period post-index and (c) change in AAER associated with hospitalization or ED visit from the 52 week period pre-index to the 52- and 104- week period post-index
Measured: During 52 weeks before treatment initiation and 52 and 104 weeks after treatment initiation
Proportion of patients with asthma exacerbations in the 52 and 104 weeks post-index
To assess the (a) proportion of patients with asthma exacerbations after 52 and 104 weeks of treatment with Tezepelumab, (b) the proportion of patients who completed the 52 week period post-index with any reduction, ≥50 percent, and 100 percent reduction in total number of asthma exacerbations compared with baseline period, and (c) the proportion of patients with asthma exacerbations resulting in hospitalization, and number of hospital days owing to exacerbations (total and averaged per patient) in the 52 week periods pre- and post-index
Measured: During 52 weeks before treatment initiation and 52 and 104 weeks after treatment initiation
Time to first asthma exacerbation from index date
To describe the time to first asthma exacerbation from index date of treatment with Tezepelumab
Measured: Until 104 weeks after treatment initiation
Proportion of patients with asthma-related Systemic Corticosteroids (SCS) and Inhaled Corticosteroids (ICS) use during the 52 week-period pre- and post-index
To assess (a) the proportion of patients with any SCS or ICS use, (b) the proportion of patients who completed the 52 week period post-index with any reduction, ≥25 percent, ≥50 percent ≥75 percent and 100 percent reduction in SCS cumulative dose (in prednisone equivalent dose) compared with baseline period, (c) the proportion of patients who completed the 52 week period post-index with any reduction, ≥50 percent (medium dose) and ≥75 percent (low dose) reduction in ICS dose compared with baseline period, (d) the proportion of patients requiring long-term (>30 consecutive days) SCS use, and the proportion of patients requiring long-term (>30 consecutive days) ICS use.
Measured: During 52 weeks before treatment initiation and 52 weeks after treatment initiation
Change in asthma-related Systemic Corticosteroids (SCS) and Inhaled Corticosteroids (ICS) use during the 52 week-period pre- and post-index
To evaluate the change in cumulative annualized SCS and ICS dose through the 52 week periods pre- and post-index
Measured: During 52 weeks before treatment initiation and 52 weeks after treatment initiation
Time to earliest Systemic Corticosteroids (SCS) use from index date
To describe the time to earliest SCS use from index date among patients that used SCS
Measured: During 52 weeks before treatment initiation and 52 weeks after treatment initiation
Change in rate and duration of asthma-related HCRU for the 52 weeks pre- and post-index
Number and proportion of patients with any asthma-related Healthcare Resource Utilization (HCRU) and type of HCRU [i.e., hospitalisations/ Emergency Department (ED) visits (without hospitalisation)/unscheduled outpatient or physician visits] Annualized rate of (a) asthma-related visits leading to hospitalisation, (b) ED visits (without hospitalisation), and (c) unscheduled outpatient or physician visits Duration (total and Intensive Care Unit Length of Stay) of asthma-related hospitalisations
Measured: During 52 weeks before treatment initiation and during 52 and 104 weeks after treatment initiation
Changes in proportion of participants achieving (a) asthma disease stability or (b) partial stability up to 104 weeks post-index
To evaluate (a) the proportion of participants achieving stable disease [all 4 criteria are met: i) Asthma Control Questionnaire-6 (ACQ-6) < 1.5 at post-index timepoint; ii) pre-bronchodilator forced expiratory volume in one second (Pre-BD FEV1) at post-index timepoint/pre-BD FEV1 at baseline >0.95; iii) ≥50 percent reduction in the annualized number of exacerbations in the follow-up period; iv) ≥ 50 percent reduction in oral corticosteroid (OCS) use in the follow-up period], and (b) the proportion of participants with partial disease stability (1 criterion, 2 criteria, and 3 criteria are met)
Measured: At weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
Duration of therapy at 52 and 104 weeks post-index
To assess the duration of treatment with tezepelumab, as well as the time to tezepelumab treatment discontinuation
Measured: At Week 52 and 104 after treatment initiation or at the moment of treatment discontinuation through study completion, an average of 2 years (104 weeks)
Discontinuation rate at 52 and 104 weeks post-index
To evaluate (a) the rate of for tezepelumab treatment discontinuation and (b) the proportion of participants switching to other biologics for asthma. To describe also the reasons for tezepelumab treatment discontinuation, using a pre-defined checklist.
Measured: At Week 52 and 104 after treatment initiation or at the moment of treatment discontinuation through study completion, an average of 2 years (104 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start17 Dec 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
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
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724575
- Sponsor's protocol ID
- D5180R00032
- Acronym
- EVOLVE
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2024
- Last updated
- 22 Sep 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 via the request portal. All request will be evaluated as per the AZ disclosure 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EVOLVE Study: A Prospective, Observational Study to Evaluate Patient-centered Outcomes Over 2 Years of Treatment With Tezepelumab in Real-life Clinical Practice in Greece
- ClinicalTrials.gov ID
- NCT06724575
- Acronym / sponsor ID
- EVOLVE / D5180R00032
- Conditions
- Asthma
- Keywords
- severe asthma, tezepelumab, real world data, patient reported outcomes, Greece
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 156 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Dec 2024 (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.
Tezepelumab is a first-in-class human monoclonal antibody for uncontrolled severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), a key epithelial cytokine inducing both Type 2 and non- Type 2 inflammatory pathways. Considering the recent addition of tezepelumab to the severe asthma therapeutic arsenal, there is a need for real-world evidence that can inform treatment-decision making in clinical practice and support regulatory decisions.
EVOLVE is a prospective, observational study designed to generate real-world evidence on patient-reported outcomes of treatment with tezepelumab, assessing the effectiveness over a 2-year period in routine care settings in Greece.
The study plans to enroll 150 adult patients at an allocation ratio of: i) 70 percent Type 2-high/30 percent Type 2-low, and ii) 80 percent biologic naïve/20 percent switching from a prior biologic. Eligible patients must be newly prescribed tezepelumab according to the approved label.
Primary data will be collected at enrollment and 4, 12, 24, 52, 72 and 104 weeks after treatment initiation through visits as per the standard clinical practice in various healthcare settings (20-25 sites) across the country.
The primary objective is to describe the patient-reported asthma symptom control using the Asthma Control Questionnaire (ACQ-6) at baseline and up to 104 weeks post-index. Secondary and exploratory objectives include assessment of quality of life, lung function, exacerbation rate, corticosteroid use, health-care utilization. Novel composite endpoints will also be evaluated such as early clinically important improvement, disease stability, super-response and clinical remission at 2 years, which in the era of precision biologics, have the potential to shift treatment paradigms toward a treat-to-target approach.
Findings of EVOLVE are expected to not only complement evidence obtained from clinical trials, but also to provide valuable insights into the long-term durability of treatment benefits and sustainability of clinical response under pragmatic clinical conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population from private practices and hospital clinics specializing in the management of Severe Asthma, in geographically diverse locations throughout Greece, with a balanced representation of public, academic and private sector in Greece.
Key inclusion criteria (11 listed)
- Male or female outpatients aged 12 years or older at the time of signing the informed consent/assent form.
- Patients who have been prescribed but not yet initiated treatment with tezepelumab according to the label and local market reimbursement criteria.
- Diagnosis of asthma for at least 52 weeks prior to enrolment date and symptoms confirmed by the Investigator not to be due to alternative diagnoses.
- Receipt of at least one prescription of high-dose Inhaled Corticosteroids (ICS) (according to the Global Initiative for Asthma 2024) during the 52 weeks prior to enrolment date.
- Use of additional asthma maintenance controller medication(s) in addition to ICS either as free- or fixed-drug combination for at least 52 weeks prior to enrolment date.
Key exclusion criteria (4 listed)
- Any contraindication to tezepelumab as per the approved product label or in the opinion of the Investigator.
- Concurrent or recent (<30 days before the index date) treatment with biologics for asthma, with the exception of stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment).
- Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months.
- Currently pregnant (or intention to become pregnant) or lactating women.
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
Change in the ACQ-6 score at baseline and up to 104 weeks post-index
Time frame: Before treatment initiation and at Weeks 4, 12, 24, 52, 72, 104 after treatment initiation
Asthma Control Questionnaire-6 (ACQ-6) score at different timepoints Change in ACQ-6 score from baseline Proportion of patients with ACQ-6 response (i.e., achieving the Minimum Clinically Important Difference (MCID) of ≥0.5 reduction in score from baseline) Proportion of patients with major improvement in asthma control (defined as decrease in ACQ-6 score ≥1 point [i.e., 2xMCID] from baseline) Proportion of patients with well-controlled asthma (ACQ-6 score ≤ 0.75) Proportion of patients with ACQ-6 score in categories 0.75 to <1.5 and ≥1.5 Time to ACQ-6 score response
15 secondary outcomes
Change in asthma-specific HRQoL using the SGRQ at baseline and up to 52 weeks post-index
Time frame: Before treatment initiation and at Weeks 24 and 52 after treatment initiation
Change in FEV1 (forced expiratory volume in 1 second) at baseline and up to 104 weeks post-index
Time frame: Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
Change in FVC (Forced Vital Capacity) at baseline and up to 104 weeks post-index
Time frame: Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
Change in pre-BD FEF25-75 (Forced Expiratory Flow) at baseline and up to 104 weeks post-index
Time frame: Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
Change in lung function at baseline and up to 104 weeks post-index
Time frame: Before treatment initiation and at Weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
Change in asthma exacerbations in the 52 and 104 weeks post-index
Time frame: During 52 weeks before treatment initiation and 52 and 104 weeks after treatment initiation
Proportion of patients with asthma exacerbations in the 52 and 104 weeks post-index
Time frame: During 52 weeks before treatment initiation and 52 and 104 weeks after treatment initiation
Time to first asthma exacerbation from index date
Time frame: Until 104 weeks after treatment initiation
Proportion of patients with asthma-related Systemic Corticosteroids (SCS) and Inhaled Corticosteroids (ICS) use during the 52 week-period pre- and post-index
Time frame: During 52 weeks before treatment initiation and 52 weeks after treatment initiation
Change in asthma-related Systemic Corticosteroids (SCS) and Inhaled Corticosteroids (ICS) use during the 52 week-period pre- and post-index
Time frame: During 52 weeks before treatment initiation and 52 weeks after treatment initiation
Time to earliest Systemic Corticosteroids (SCS) use from index date
Time frame: During 52 weeks before treatment initiation and 52 weeks after treatment initiation
Change in rate and duration of asthma-related HCRU for the 52 weeks pre- and post-index
Time frame: During 52 weeks before treatment initiation and during 52 and 104 weeks after treatment initiation
Changes in proportion of participants achieving (a) asthma disease stability or (b) partial stability up to 104 weeks post-index
Time frame: At weeks 4, 12, 24, 52, 72 and 104 after treatment initiation
Duration of therapy at 52 and 104 weeks post-index
Time frame: At Week 52 and 104 after treatment initiation or at the moment of treatment discontinuation through study completion, an average of 2 years (104 weeks)
Discontinuation rate at 52 and 104 weeks post-index
Time frame: At Week 52 and 104 after treatment initiation or at the moment of treatment discontinuation through study completion, an average of 2 years (104 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure 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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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.
8 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 8 sites in Greece.
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 11 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Greece. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in the ACQ-6 score at baseline and up to 104 weeks post-index (time frame: Before treatment initiation and at Weeks 4, 12, 24, 52, 72, 104 after treatment initiation). 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 22 Sep 2026.