NCT05136547|Completed
Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database
HAYATE
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HAYATE
Sponsor study identifier
observational
2,927
1 country
1
Study Start
January 6, 2022
Actual (reported)Primary Completion
May 16, 2022
Actual (reported)Study Completion
May 16, 2022
Actual (reported)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 .
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 16, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 25, 2021
Actual (reported)November 29, 2021
Actual (reported)January 6, 2022
Actual (reported)May 16, 2022
Actual (reported)May 16, 2022
Actual (reported)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
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
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
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.
Research Site
Tokyo, Japan
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.
2,927 participants (actual enrollment reported by the registry).
First Submitted
October 25, 2021
First Posted
November 29, 2021
Study Start
January 6, 2022
Actual (reported)Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
Contact the study team to confirm eligibility.
Primary Completion
May 16, 2022
Actual (reported)Study Completion
May 16, 2022
Actual (reported)Last Updated
March 17, 2023
Record last verified: 2023-03
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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