Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 2,927
- Locations
- 1
- Primary Endpoint
- Percentage of patients who achieved >0%, ≥25%, ≥50%, 100% OCS reduction of daily maintenance OCS dose from week-0 to week-24 respectively.
Study Overview
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 .
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 16 Years to 130 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
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).
Outcomes
Primary Outcomes
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
Percentage reduction on daily dose of maintenance OCS from week-0 to week-24
Time Frame: from week-0 to week-24
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
Secondary Outcomes
- 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)