Last updated: 10/28/2024 11:50:13

Study of the Effectiveness of Mepolizumab in Patients with Nasal Polyps

GSK study ID
217462
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: Study of the Effectiveness of Mepolizumab in Asthma Patients with Comorbid Nasal Polyps
Trial description: To characterize the effectiveness of mepolizumab in real-world population of asthma participants with comorbid Nasal polyps (NP). Asthma participants with NP initiating mepolizumab will be identified in the MarketScan Commercial and Medicare Databases and are required to have continuous enrollment in the 12 months before and after initiation of mepolizumab diagnosis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with NP-related outcomes

Timeframe: 12 months pre-dose to 12 months post-dose

Number of participants with NP-Related oral corticosteroids (OCS) Use

Timeframe: 12 months pre-dose to 12 months post-dose

Number of participants who experience any asthma exacerbation

Timeframe: 12 months pre-dose to 12 months post-dose

Number of participants with all cause OCS use

Timeframe: 12 months per-dose to 12 months post-dose

Number of participants receiving asthma related treatments

Timeframe: 12 months pre-dose to 12 months post-dose

Secondary outcomes:

Demographic characteristics of asthma participants with comorbid NP

Timeframe: 12 months pre-dose to 12 months post-dose

Clinical characteristics of asthma participants with comorbid NP

Timeframe: 12 months pre-dose to 12 months post-dose

Interventions:
  • Drug: Mepolizumab
    • Enrollment:
    0
    Primary completion date:
    2023-14-06
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Jonathan A Bernstein, Jared Silver, Elizabeth Packnett, Carolyn R Lew, Yvonne Robles, Arijita Deb. Real-world unified airway benefits of mepolizumab: Effectiveness in patients with asthma and comorbid nasal polyps. Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology. 2024-Jul-06 PMID: 38972449 DOI: 10.1016/j.anai.2024.06.033
    Medical condition
    Nasal Polyps
    Product
    mepolizumab
    Collaborators
    Not applicable
    Study date(s)
    October 2022 to June 2023
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • At least one medical or pharmacy claim for mepolizumab between November 1, 2015, and September 30, 2020; the date of first mepolizumab claim will be the index date
    • At least 12 months of continuous enrollment with medical and pharmacy benefits before the index date. This is the baseline period
    • Evidence of mepolizumab use prior to index date
    • Evidence of medical or pharmacy claims for benralizumab, omalizumab, reslizumab, or dupilumab, during the baseline or follow-up period
    Inclusion and exclusion criteria
    Inclusion criteria:
    • At least one medical or pharmacy claim for mepolizumab between November 1, 2015, and September 30, 2020; the date of first mepolizumab claim will be the index date
    • At least 12 months of continuous enrollment with medical and pharmacy benefits before the index date. This is the baseline period
    • At least 12 months of continuous enrollment with medical and pharmacy benefits after the index date. This is the follow-up period
    • At least 18 years old on the index date
    • At least one non-diagnostic inpatient or outpatient claim with a diagnosis of asthma in the baseline period
    • At least one non-diagnostic inpatient or outpatient claim with a diagnosis of NP in the baseline period
    • At least two medical or pharmacy claims for mepolizumab during the first six months of the follow-up period
    Exclusion criteria:
    • Evidence of mepolizumab use prior to index date
    • Evidence of medical or pharmacy claims for benralizumab, omalizumab, reslizumab, or dupilumab, during the baseline or follow-up period

    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
    2023-14-06
    Actual study completion date
    2023-14-06

    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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