Last updated: 04/07/2024 17:50:17

Real-world outcomes of mepolizumab

GSK study ID
211271
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Real-world outcomes of mepolizumab for the treatment of severe eosinophilic asthma
Trial description: This study will investigate the real-world impact of mepolizumab on asthma related outcomes and the associated costs among severe asthma subjects. This study will use the Patient Support Program (PSP) to identify mepolizumab subjects. The purpose of this study is to help understand and measure the potential real-world effectiveness of mepolizumab utilization amongst severe eosinophilic asthma subjects in Canada. This will be a retrospective observational 12 months pre- and 12 months post- mepolizumab initiation study using Canada Nucala PSP database and Institute for Clinical Evaluative Sciences (IC/ES) database. This study will consist of following periods: look back period, pre-mepolizumab period, selection period, post-mepolizumab period, categorization period and post-mepolizumab period. Subjects will be identified from 01 February 2016 and 31 January 2018 (index date) from the Canadian mepolizumab PSP.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects with demographics characteristics

Timeframe: Up to 2 years

Number of subjects with clinical characteristics

Timeframe: Up to 2 years

Number of subjects with asthma-related real-world outcomes

Timeframe: Up to 2 years

Asthma-related healthcare costs

Timeframe: Up to 2 years

Secondary outcomes:

Number of subjects with asthma-related real-world outcomes in highly adherent subgroups

Timeframe: Up to 2 years

Asthma-related healthcare costs in highly adherent subgroups

Timeframe: Up to 2 years

Interventions:
Drug: Mepolizumab
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2022-31-08
Time perspective:
Retrospective
Clinical publications:
Kenneth R Chapman, Kathryn Cogger, Erin Arthurs, Callahan LaForty, Shane Golden, Bradley Millson, Koyo Usuba, Christopher Licskai. Real-world outcomes of mepolizumab for the treatment of severe eosinophilic asthma in Canada: an observational study.. Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology. 2024-02-04;20(1): 11 DOI: 0.1186/s13223-023-00863-7 PMID: 38311747
Medical condition
Asthma
Product
mepolizumab
Collaborators
IQVIA, Institute for Clinical Evaluative Sciences
Study date(s)
July 2021 to August 2022
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Inclusion Criteria :
  • Severe eosinophilic asthma subjects on mepolizumab
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion Criteria : Severe eosinophilic asthma subjects on mepolizumab
  • Subjects must have signed the study informed consent form.
  • Subjects must have received at least one injection of mepolizumab.
  • Subjects must be obtained from the Canadian Mepolizumab PSP database and identified within the IC/ES database.
  • Subjects must be 18 years of age and older at index date.
  • Subjects must initiate mepolizumab utilization within the selection period.
  • Active within the IC/ES database for 1 year prior to index date. Additional inclusion criteria for ODB PSP population
  • Subjects must be ODB subject/ or part of other publicly funded programs. Sub Cohort: severe eosinophilic asthma subjects on mepolizumab who are highly adherent In order to be eligible to participate in the subgroup analysis study, the subjects identified as severe eosinophilic asthma subject on mepolizumab based on the above inclusion criteria must also meet the following criteria:
  • The study subject must have nine or more injections (>=9 injections) over one-year categorization period on mepolizumab to qualify as highly adherent. This subgroup analysis will include a secondary level of inclusion criteria to further subdivide the highly adherent subgroup.
  • ODB PSP population–Baseline exacerbation >=2: Subject must have two or more exacerbations during the pre-mepolizumab initiation period for the highly adherent subgroup.
  • ODB PSP population–Baseline exacerbation >=2 with Eosinophil cut points 150-299: Subject must have two or more exacerbations during the pre-mepolizumab initiation period for the highly adherent subgroup and must have an eosinophil level between 150 and 299.
  • ODB PSP population–Baseline exacerbation >=2 with Eosinophil cut points >=300: Subject must have two or more exacerbations during the pre-mepolizumab initiation period for the highly adherent subgroup and must have an eosinophil level equal to or above 300.
  • ODB PSP Population–Baseline exacerbation >=3: Subject must have three or more exacerbations during the pre-mepolizumab initiation period for the highly adherent subgroup.

Trial location(s)

No location data available.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2022-31-08
Actual study completion date
2022-31-08

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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