Clinical trial NCT05136547: Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database
Official title: Comparative Study of the Efficacy of Biologics vs Usual Treatment on OCS Reduction for Severe Asthma Patients Using Health Insurance Claim Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-11-29
Enrollment: 2927
Sex: ALL
Minimum age (years): 16
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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 .


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage reduction on daily dose of maintenance OCS from week-0 to week-24
timeFrame: from week-0 to week-24
measure: Percentage of patients who achieved >0%, ≥25%, ≥50%, 100% OCS reduction of daily maintenance OCS dose from week-0 to week-24 respectively.
timeFrame: from week-0 to week-24
measure: Total amount of maintenance OCS prescribed during outcome period.
timeFrame: from index date to 24 weeks later
measure: Percentage reduction on daily dose of maintenance OCS from week-0 to week-24 with two groups.
timeFrame: from week-0 to week-24
measure: Total amount of SCS during outcome period.
timeFrame: from index date to 24 weeks later
Secondary outcomes:
measure: Percentage of OCS reduction of maintenance OCS dose from week-0 to week-8.
timeFrame: from week-0 to week-8.
measure: Percentage of OCS reduction of maintenance OCS dose from week-0 to week-16.
timeFrame: from week-0 to week-16
Other outcomes:
measure: 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.
timeFrame: from week-0 to week-24
measure: Total amount of maintenance OCS prescribed during one year and two years respectively.
timeFrame: during one year and two years
measure: Total amount of SCS during one year and two year respectively.
timeFrame: during one year and two years
measure: Percentage of patients with an exacerbation during outcome period.
timeFrame: from index date to 24 weeks later
measure: Percentage of patients with no exacerbation during outcome period.
timeFrame: from index date to 24 weeks later
measure: Annualized exacerbation rate.
timeFrame: from index date to 24 weeks later
measure: Percentage of patients who used asthma related medication during baseline period and outcome period respectively.
timeFrame: during baseline period and outcome period
measure: The total canisters of SABA prescribed during baseline period and outcome period respectively.
timeFrame: during baseline period and outcome period
measure: Percentage of patients who received high dose ICS or high dose ICS/LABA during outcome period.
timeFrame: from index date to 24 week later
Locations:
city: Tokyo
country: Japan
facility: Research Site
Study officials:
References: