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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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| Measure | Description | Time Frame |
|---|---|---|
| Percentage reduction on daily dose of maintenance OCS from week-0 to week-24 | 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 | from week-0 to week-24 |
| Total amount of maintenance OCS prescribed during outcome period. | 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 â‘ 5mg/day or more and â‘¡10mg/day or more respectively. | from week-0 to week-24 |
| Total amount of SCS during outcome period. | from index date to 24 weeks later |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of OCS reduction of maintenance OCS dose from week-0 to week-8. | from week-0 to week-8. | |
| Percentage of OCS reduction of maintenance OCS dose from week-0 to week-16. | from week-0 to week-16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Total amount of maintenance OCS prescribed during one year and two years respectively. |
Inclusion Criteria:
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).
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37600852 | Derived | Tanaka A, Takahashi M, Fukui A, Arita Y, Fujiwara M, Makita N, Tashiro N. Oral Corticosteroid Reduction Between Biologics Initiated and Non-Initiated Patients with Severe Asthma. J Asthma Allergy. 2023 Aug 14;16:839-849. doi: 10.2147/JAA.S411404. eCollection 2023. |
| Label | URL |
|---|---|
| Related Info | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract fordata accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| during one year and two years |
| Total amount of SCS during one year and two year respectively. | during one year and two years |
| Percentage of patients with an exacerbation during outcome period. | from index date to 24 weeks later |
| Percentage of patients with no exacerbation during outcome period. | from index date to 24 weeks later |
| Annualized exacerbation rate. | from index date to 24 weeks later |
| Percentage of patients who used asthma related medication during baseline period and outcome period respectively. | during baseline period and outcome period |
| The total canisters of SABA prescribed during baseline period and outcome period respectively. | during baseline period and outcome period |
| Percentage of patients who received high dose ICS or high dose ICS/LABA during outcome period. | from index date to 24 week later |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |