Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database
HAYATE
1 other identifier
observational
2,927
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2021
CompletedFirst Posted
Study publicly available on registry
November 29, 2021
CompletedStudy Start
First participant enrolled
January 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2022
CompletedMarch 17, 2023
March 1, 2023
4 months
October 25, 2021
March 15, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
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.
(the number of patients who achieved \>0%, ≥25%, ≥50%, 100% OCS reduction of daily maintenance OCS dose) / (number of total patients ) x 100
from week-0 to week-24
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.
Two groups are amount of regular OCS use at index date is ①5mg/day or more and ②10mg/day or more respectively.
from week-0 to week-24
Total amount of SCS during outcome period.
from index date to 24 weeks later
Secondary Outcomes (2)
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 Outcomes (9)
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
- +6 more other outcomes
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- \. 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Tokyo, Japan
Related Publications (1)
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.
PMID: 37600852DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2021
First Posted
November 29, 2021
Study Start
January 6, 2022
Primary Completion
May 16, 2022
Study Completion
May 16, 2022
Last Updated
March 17, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract fordata accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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.