Last updated: 06/29/2022 11:30:08
Mepolizumab use and effectiveness in Real-World settings in Japan
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Effectiveness of Nucala in Severe Eosinophilic Asthma in Japan using MDV
Trial description: The Japanese Ministry of Health, Labor and Welfare approved NUCALA® (mepolizumab) in March 2016 for treatment of participants with refractory asthma. Mepolizumab has been shown to reduce asthma exacerbations by greater than 50 percent (%) in participants with severe asthma in clinical trials. This is a retrospective observational study to assess the changes in asthma exacerbations among participants who have 12 months of continuous enrolment prior to and following the date of first mepolizumab administration (index date) by using real-world data derived from the Medical Data Vision (MDV) database. This study will also analyze treatments and healthcare costs associated with asthma exacerbations. Participants who administered mepolizumab between 07-Jun-2016 and 30-Sep-2018 will be included. NUCALA is a registered trademark of GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Total number of asthma exacerbations per participant-years during Baseline period
Timeframe: Baseline (12 months pre-index date)
Total number of asthma exacerbations per participant years after first mepolizumab administration
Timeframe: 12 months post-index date
Secondary outcomes:
Percentage of participants experiencing any asthma exacerbations during Baseline period
Timeframe: Baseline (12 months pre-index date)
Percentage of participants experiencing any asthma exacerbations after first mepolizumab administration
Timeframe: 12 months post-index date
Number of participants experiencing asthma-related exacerbations resulting in hospitalization during Baseline period
Timeframe: Baseline (12 months pre-index date)
Number of participants experiencing asthma-related exacerbations resulting in hospitalization after first mepolizumab administration
Timeframe: 12 months post-index date
Percentage of participants on maintenance oral corticosteroids (OCS) therapy during Baseline period
Timeframe: Baseline (12 months pre-index date)
Percentage of participants on maintenance OCS therapy after first mepolizumab administration
Timeframe: 12 months post-index date
Average daily dose of maintenance OCS therapy during Baseline period
Timeframe: Baseline (12 months pre-index date)
Average daily dose of maintenance OCS therapy after first mepolizumab administration
Timeframe: 12 months post-index date
Asthma exacerbation-related healthcare resource use during Baseline period
Timeframe: Baseline (12 months pre-index date)
Asthma exacerbation-related healthcare resource use after first mepolizumab administration
Timeframe: 12 months post-index date
Asthma exacerbation-related healthcare cost during Baseline period
Timeframe: Baseline (12 months pre-index date)
Asthma exacerbation-related healthcare cost after first mepolizumab administration
Timeframe: 12 months post-index date
Interventions:
Not applicable
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2021-24-02
Time perspective:
Retrospective
Clinical publications:
Nagase H, Tamaoki J, Suzuki T, Nezu Y, Akiyama S, Cole A, Yang S, Mu G, Katsumata M, Komatsubara M, Alfonso R. Reduction in asthma exacerbation rate after mepolizumab treatment initiation in patients with severe asthma: A real-world database study in Japan. Pulm Pharmacol Ther. 2022;
DOI:https://doi.org/10.1016/j.pupt.2022.102130
PMID:NULL
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
April 2020 to February 2021
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Medical (inpatient/outpatient) claim between 07-Jun-2016 and 30-Sep-2018 or the most recent update at the time of analysis, with a medication code indicating administration of mepolizumab.
- 12 months of continuous enrolment in the year prior to the index date (Baseline period).
- Evidence of mepolizumab use during the 12-month Baseline period.
- Participants with inconsistent or missing information on age and sex.
Inclusion and exclusion criteria
Inclusion criteria:
- Medical (inpatient/outpatient) claim between 07-Jun-2016 and 30-Sep-2018 or the most recent update at the time of analysis, with a medication code indicating administration of mepolizumab.
- 12 months of continuous enrolment in the year prior to the index date (Baseline period).
- 12 months of continuous enrolment including and following the index date (follow-up period).
- Continuous enrolment: any consultation in each quarter during the Baseline and follow-up period.
- A diagnosis of asthma during the 12-month Baseline period.
- At least 12 years of age as of index.
Exclusion criteria:
- Evidence of mepolizumab use during the 12-month Baseline period.
- Participants with inconsistent or missing information on age and sex.
- Participants with eosinophilic granulomatosis with polyangiitis (EGPA) diagnosis in Baseline period.
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2021-24-02
Actual study completion date
2021-24-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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