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
Study complete
Study complete
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
    Primary completion date:
    2022-31-08
    Observational study model:
    Cohort
    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)

    This study does not involve prospective enrollment of participants.

    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
    Study complete
    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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