Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database

Completed

• Conditions: Asthma

• Registration Number: NCT05136547
• Lead Sponsor: AstraZeneca

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-29
• Study Start: 2022-01-06
• Primary Completion: 2022-05-16
• Study Completion: 2022-05-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2927

Inclusion Criteria

1. Patients aged ≥16 years at index date.
2. 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).
3. 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.
4. Patients who had a total of 12 weeks of OCS prescribed during the baseline period including the index date.

Exclusion Criteria

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Percentage reduction on daily dose of maintenance OCS from week-0 to week-24	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.	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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tokyo, Japan