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NCT Number: NCT05136547

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

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 .

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

16 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

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

    Time frame: from week-0 to week-24

  2. Percentage of patients who achieved >0%, ≥25%, ≥50%, 100% OCS reduction of daily maintenance OCS dose from week-0 to week-24 respectively.

    Time frame: 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

  3. Total amount of maintenance OCS prescribed during outcome period.

    Time frame: from index date to 24 weeks later

  4. Percentage reduction on daily dose of maintenance OCS from week-0 to week-24 with two groups.

    Time frame: 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.

  5. Total amount of SCS during outcome period.

    Time frame: from index date to 24 weeks later

Secondary outcomes

  1. Percentage of OCS reduction of maintenance OCS dose from week-0 to week-8.

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

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

    Time frame: from week-0 to week-16

Other outcomes

  1. 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.

    Time frame: from week-0 to week-24

  2. Total amount of maintenance OCS prescribed during one year and two years respectively.

    Time frame: during one year and two years

  3. Total amount of SCS during one year and two year respectively.

    Time frame: during one year and two years

  4. Percentage of patients with an exacerbation during outcome period.

    Time frame: from index date to 24 weeks later

  5. Percentage of patients with no exacerbation during outcome period.

    Time frame: from index date to 24 weeks later

  6. Annualized exacerbation rate.

    Time frame: from index date to 24 weeks later

  7. Percentage of patients who used asthma related medication during baseline period and outcome period respectively.

    Time frame: during baseline period and outcome period

  8. The total canisters of SABA prescribed during baseline period and outcome period respectively.

    Time frame: during baseline period and outcome period

  9. Percentage of patients who received high dose ICS or high dose ICS/LABA during outcome period.

    Time frame: from index date to 24 week later

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: HAYATE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2021
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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