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

AstraZeneca2,927 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

2,927

Conditions

Asthma

Eligibility

Sex: ALLMin age: 16 YearsMax age: 130 Years

Medical Language ↔ Plain English

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).

Locations (1)

Research Site

Tokyo, Japan

Outcomes

Primary Outcomes

Percentage reduction on daily dose of maintenance OCS from week-0 to week-24

Time frame: 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

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.

Two groups are amount of regular OCS use at index date is ①5mg/day or more and ②10mg/day or more respectively.

Time frame: from week-0 to week-24

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.

Time frame: from week-0 to week-8.

Percentage of OCS reduction of maintenance OCS dose from week-0 to week-16.

Time frame: from week-0 to week-16

Data from ClinicalTrials.gov

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