AsthmaHAYATENCT05136547
Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database
An observational study of Asthma, run by AstraZeneca at 1 site in Japan.
Trial summary
This study is a retrospective cohort study of patients diagnosed with asthma based on the data extracted from the MDV database. The study period is from 1st Jun 2016 to 29th February 2020 . Read more about this study
- Who is it for?
- Ages 16 to 130 years
- Conditions the study is for
- Asthma
- How many people
- 2,927 participants
- Where
- 1 siteJapan
- Study dates
- 6 Jan 2022to 16 May 2022
- 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 16 to 130 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All individuals who meet followed inclusion / exclusion criteria will be identified between study period in the MDV database, and will be included in Full Analysis Set.
Who may be able to join
- Patients aged ≥16 years at index date.
- Patients with records of receiving high dose ICS or high dose ICS/LABA and diagnosed as asthma (ICD-10 code: J45 or J46 ) during baseline period. High dose ICS and high dose ICS/LABA will be defined in the appendices (Table 6-9).
- Patients who had visit histories at least one visit during baseline period, at least two visits during outcome period and at least one visit after outcome period.
- Patients who had a total of 12 weeks of OCS prescribed during the baseline period including the index date.
Who cannot join
- 1. Patients diagnosed with selected autoimmune diseases during the baseline period because OCS is used as a therapeutic agent for these disease. Autoimmune disease will be identified by following ICD-10 code (M30, M05, M06, L93, M32, K50, K51, K52, N04).
Trial locations and contacts
1 site in 1 country.
About this study
This study is a retrospective cohort study of patients diagnosed with asthma based on the data extracted from the MDV database. The study period is from 1st Jun 2016 to 29th February 2020 .
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction on daily dose of maintenance OCS from week-0 to week-24
Measured: from week-0 to week-24
Percentage of patients who achieved >0%, ≥25%, ≥50%, 100% OCS reduction of daily maintenance OCS dose from week-0 to week-24 respectively.
(the number of patients who achieved >0%, ≥25%, ≥50%, 100% OCS reduction of daily maintenance OCS dose) / (number of total patients ) x 100
Measured: from week-0 to week-24
Total amount of maintenance OCS prescribed during outcome period.
Measured: from index date to 24 weeks later
Percentage reduction on daily dose of maintenance OCS from week-0 to week-24 with two groups.
Two groups are amount of regular OCS use at index date is ①5mg/day or more and ②10mg/day or more respectively.
Measured: from week-0 to week-24
Total amount of SCS during outcome period.
Measured: from index date to 24 weeks later
Secondary outcomes (2)
Percentage of OCS reduction of maintenance OCS dose from week-0 to week-8.
Measured: from week-0 to week-8.
Percentage of OCS reduction of maintenance OCS dose from week-0 to week-16.
Measured: from week-0 to week-16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start6 Jan 2022
- Primary completion16 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 2,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136547
- Sponsor's protocol ID
- D3250R00092
- Acronym
- HAYATE
- Status last verified
- Mar 2023
- First submitted
- 25 Oct 2021
- Last updated
- 17 Mar 2023
- Results posted
- 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 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.
Publications
Tanaka A, Takahashi M, Fukui A, Arita Y, Fujiwara M, Makita N, Tashiro N. Oral Corticosteroid Reduction Between Biologics Initiated and Non-Initiated Patients with Severe Asthma. J Asthma Allergy. 2023 Aug 14;16:839-849. doi: 10.2147/JAA.S411404. eCollection 2023.
PubMed 37600852
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database
- ClinicalTrials.gov ID
- NCT05136547
- Acronym / sponsor ID
- HAYATE / D3250R00092
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,927 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 29 Nov 2021 (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 is a retrospective cohort study of patients diagnosed with asthma based on the data extracted from the MDV database. The study period is from 1st Jun 2016 to 29th February 2020 .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals who meet followed inclusion / exclusion criteria will be identified between study period in the MDV database, and will be included in Full Analysis Set.
Key inclusion criteria (4 listed)
- Patients aged ≥16 years at index date.
- Patients with records of receiving high dose ICS or high dose ICS/LABA and diagnosed as asthma (ICD-10 code: J45 or J46 ) during baseline period. High dose ICS and high dose ICS/LABA will be defined in the appendices (Table 6-9).
- Patients who had visit histories at least one visit during baseline period, at least two visits during outcome period and at least one visit after outcome period.
- Patients who had a total of 12 weeks of OCS prescribed during the baseline period including the index date.
Key exclusion criteria (1 listed)
- 1. Patients diagnosed with selected autoimmune diseases during the baseline period because OCS is used as a therapeutic agent for these disease. Autoimmune disease will be identified by following ICD-10 code (M30, M05, M06, L93, M32, K50, K51, K52, N04).
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
Percentage reduction on daily dose of maintenance OCS from week-0 to week-24
Time frame: from week-0 to week-24
Percentage of patients who achieved >0%, ≥25%, ≥50%, 100% OCS reduction of daily maintenance OCS dose from week-0 to week-24 respectively.
Time frame: from week-0 to week-24
(the number of patients who achieved >0%, ≥25%, ≥50%, 100% OCS reduction of daily maintenance OCS dose) / (number of total patients ) x 100
Total amount of maintenance OCS prescribed during outcome period.
Time frame: from index date to 24 weeks later
Percentage reduction on daily dose of maintenance OCS from week-0 to week-24 with two groups.
Time frame: from week-0 to week-24
Two groups are amount of regular OCS use at index date is ①5mg/day or more and ②10mg/day or more respectively.
Total amount of SCS during outcome period.
Time frame: from index date to 24 weeks later
2 secondary outcomes
Percentage of OCS reduction of maintenance OCS dose from week-0 to week-8.
Time frame: from week-0 to week-8.
Percentage of OCS reduction of maintenance OCS dose from week-0 to week-16.
Time frame: from week-0 to week-16
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 17 Mar 2023.
- Derived from this study: PubMed 37600852Tanaka A, Takahashi M, Fukui A, Arita Y, Fujiwara M, Makita N, Tashiro N. Oral Corticosteroid Reduction Between Biologics Initiated and Non-Initiated Patients with Severe Asthma. J Asthma Allergy. 2023 Aug 14;16:839-849. doi: 10.2147/JAA.S411404. eCollection 2023.
- Related InfoLink 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 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.
1 site 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 1 site 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 4 inclusion and 1 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 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Percentage reduction on daily dose of maintenance OCS from week-0 to week-24 (time frame: from week-0 to week-24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05136547, which also lists 1 linked publication.
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 17 Mar 2023.