Last updated: 12/09/2024 12:00:18

MEPOLYP: - Real-World Effectiveness of Mepolizumab with Severe Eosinophilic Asthma (SEA) and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

GSK study ID
219821
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: MEPOLYP: - Real-world effectiveness of MEpolizumab in patients with severe eosinophilic asthma and comorbid chronic rhinosinusitis with or without nasal POLYPs
Trial description: The aim of this multi-country study is to assess participant characteristics as well as treatment outcomes pre- and post-mepolizumab initiation in Severe Eosinophilic Asthma (SEA) participants with or without comorbid Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) from existing SEA registries.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change in Clinically Significant Asthma Exacerbations Rates with respect to Oral Corticosteroids [OCS] bursts for Participants With and Without Comorbid CRSwNP

Timeframe: At 12 months pre-dose and 12 months post-dose

Change in Clinically Significant Asthma Exacerbations Rates with respect to Emergency Room (ER) Visits for Participants With and Without Comorbid CRSwNP

Timeframe: At 12 months pre-dose and 12 months post-dose

Change in Clinically Significant Asthma Exacerbations Rates with respect to Hospitalizations for Participants With and Without Comorbid CRSwNP

Timeframe: At 12 months pre-dose and 12 months post-dose

Secondary outcomes:

Change in Rate of Asthma Exacerbations that Required Emergency Room (ER) Visits/ Hospitalization for Participants With and Without Comorbid CRSwNP

Timeframe: At 12 months pre-dose and 12 months post-dose

Change in Rate of Asthma Exacerbations that Required Hospitalization for Participants With and Without Comorbid CRSwNP

Timeframe: At 12 months pre-dose and 12 months post-dose

Change in Median Oral Corticosteroids [OCS] Maintenance Dose for Participants With and Without Comorbid CRSwNP

Timeframe: At 12 months pre-dose, 6 months and 12 months post-dose

Change in Forced Expiratory Volume in 1 Second (FEV1) Values for Participants With and Without Comorbid CRSwNP

Timeframe: At 12 months pre-dose, 6 months and 12 months post-dose

Change in Asthma Control Test (ACT) Scores for Participants With and Without Comorbid CRSwNP

Timeframe: At 12 months pre-dose, 6 months and 12 months post-dose

Demographic, Clinical and Disease Characteristics of Participants With and Without Comorbid CRSwNP

Timeframe: At 12 months pre-dose

Asthma Treatment Patterns (e.g., OCS, Inhaled Corticosteroids [ICS], Inhaled Treatments) Before Mepolizumab Initiation for Participants With and Without Comorbid CRSwNP

Timeframe: At 12 months pre-dose

Interventions:
  • Drug: Mepolizumab
    • Enrollment:
    0
    Primary completion date:
    2024-15-07
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    mepolizumab
    Collaborators
    Not applicable
    Study date(s)
    November 2023 to July 2024
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Participants should be able to sign Informed Consent
    • Participants must have a current clinical diagnosis of SEA and can be either included in prior published material or newly enrolled into the registry
    • Any mention of participation in an interventional clinical trial during the observational study period
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participants should be able to sign Informed Consent
    • Participants must have a current clinical diagnosis of SEA and can be either included in prior published material or newly enrolled into the registry
    • Physician decision to prescribe treatment with mepolizumab
    • Relevant records available for at least 12-months prior to index date and at least 12-months post-index date
    Exclusion criteria:
    • Any mention of participation in an interventional clinical trial during the observational study period

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    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
    2024-15-07
    Actual study completion date
    2024-15-07

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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