HAYATE: Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database
Study Details
Study Description
Brief 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 .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Percentage reduction on daily dose of maintenance OCS from week-0 to week-24 [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. [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. [from index date to 24 weeks later]
- Percentage reduction on daily dose of maintenance OCS from week-0 to week-24 with two groups. [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. [from index date to 24 weeks later]
Secondary Outcome Measures
- Percentage of OCS reduction of maintenance OCS dose from week-0 to week-8. [from week-0 to week-8.]
- Percentage of OCS reduction of maintenance OCS dose from week-0 to week-16. [from week-0 to week-16]
Other Outcome Measures
- Percentage reduction on daily dose of maintenance OCS from week-0 to week-24 between benralizumab or mepolizumab initiated severe asthma patients with regular maintenance OCS use and BIO non-initiated severe asthma patients with regular. [from week-0 to week-24]
- Total amount of maintenance OCS prescribed during one year and two years respectively. [during one year and two years]
- Total amount of SCS during one year and two year respectively. [during one year and two years]
- Percentage of patients with an exacerbation during outcome period. [from index date to 24 weeks later]
- Percentage of patients with no exacerbation during outcome period. [from index date to 24 weeks later]
- Annualized exacerbation rate. [from index date to 24 weeks later]
- Percentage of patients who used asthma related medication during baseline period and outcome period respectively. [during baseline period and outcome period]
- The total canisters of SABA prescribed during baseline period and outcome period respectively. [during baseline period and outcome period]
- Percentage of patients who received high dose ICS or high dose ICS/LABA during outcome period. [from index date to 24 week later]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged ≥16 years at index date.
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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).
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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.
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Patients who had a total of 12 weeks of OCS prescribed during the baseline period including the index date.
Exclusion Criteria:
- 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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Tokyo | Japan |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D3250R00092