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

Asthma Clinical Trial

— HAYATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136547
• Other study ID #: D3250R00092
• Status: Completed
• Start date: January 6, 2022
• Est. completion date: May 16, 2022

Study information

• Verified date: March 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2927
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 130 Years

Eligibility

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).

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Japan	Research Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Total amount of maintenance OCS prescribed during one year and two years respectively.		during one year and two years
Other	Total amount of SCS during one year and two year respectively.		during one year and two years
Other	Percentage of patients with an exacerbation during outcome period.		from index date to 24 weeks later
Other	Percentage of patients with no exacerbation during outcome period.		from index date to 24 weeks later
Other	Annualized exacerbation rate.		from index date to 24 weeks later
Other	Percentage of patients who used asthma related medication during baseline period and outcome period respectively.		during baseline period and outcome period
Other	The total canisters of SABA prescribed during baseline period and outcome period respectively.		during baseline period and outcome period
Other	Percentage of patients who received high dose ICS or high dose ICS/LABA during outcome period.		from index date to 24 week later
Primary	Percentage reduction on daily dose of maintenance OCS from week-0 to week-24		from week-0 to week-24
Primary	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
Primary	Total amount of maintenance OCS prescribed during outcome period.		from index date to 24 weeks later
Primary	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 ?5mg/day or more and ?10mg/day or more respectively.	from week-0 to week-24
Primary	Total amount of SCS during outcome period.		from index date to 24 weeks later
Secondary	Percentage of OCS reduction of maintenance OCS dose from week-0 to week-8.		from week-0 to week-8.
Secondary	Percentage of OCS reduction of maintenance OCS dose from week-0 to week-16.		from week-0 to week-16

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