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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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AstraZeneca

Status

Completed

Conditions

Asthma

Study type

Observational

Funder types

Industry

Identifiers

NCT05136547
D3250R00092

Details and patient eligibility

About

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 .

Enrollment

2,927 patients

Sex

All

Ages

16 to 130 years old

Volunteers

No Healthy Volunteers

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).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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