Last updated: 09/25/2024 10:50:09

Nucala Impact in Pediatric and Adolescent

GSK study ID
218952
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: Association of Mepolizumab with Asthma-Related Outcomes in Pediatric and Adolescent Patients with Severe Asthma: A Pre/Post Assessment of Oral Corticosteroid and Asthma Medication Use, Asthma Exacerbations, and Healthcare Resource Utilization in the United States
Trial description: This is a retrospective pre-post study design, used to evaluate differences in Oral Corticosteroid (OCS) use, asthma exacerbations, Short-Acting Beta Agonist (SABA) use, and Healthcare Resource Utilization (HRU) before and after mepolizumab initiation among pediatric and adolescent participants with severe asthma in the United States (US).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Mean number of OCS dispensing before and after mepolizumab initiation

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

Total number of inpatient/emergency department (IP/ED)-defined asthma exacerbations

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

Total number of SCS-defined asthma exacerbations

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

Secondary outcomes:

Number and percentage of participants receiving greater than or equal to (≥)1 OCS

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

Mean number of OCS bursts Per Patient Year (PPY)

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

Number and percentage of participants with chronic OCS use

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

Number and percentage of participants with maintenance OCS use

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

Mean daily dose of OCS dispensing

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

Number and percentage of participants with ≥1 SABA canister

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

Mean number of SABA canisters

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

All-cause related HRU

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

Asthma related HRU

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

Asthma exacerbation related HRU

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

OCS use among pediatric (6-11 years) and adolescent (12-17 years) participants

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

Asthma exacerbations among pediatric (6-11 years) and adolescent (12-17 years) participants

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

SABA use among pediatric (6-11 years) and adolescent (12-17 years) participants

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

HRU among pediatric (6-11 years) and adolescent (12-17 years) participants

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

Interventions:
  • Drug: Mepolizumab
    • Enrollment:
    0
    Primary completion date:
    2024-28-02
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    mepolizumab
    Collaborators
    Not applicable
    Study date(s)
    August 2023 to February 2024
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 17 Years
    Accepts healthy volunteers
    No
    • Greater than or equal to (≥)1 medical or pharmacy claim for mepolizumab after October 1, 2016
    • 12 months of continuous eligibility prior to the index date
    • ≥1 diagnosis of any of the following conditions in the primary or secondary position at any time during the study period:
    • a. Active tuberculosis
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Greater than or equal to (≥)1 medical or pharmacy claim for mepolizumab after October 1, 2016
    • 12 months of continuous eligibility prior to the index date
    • 12 months of continuous eligibility after the index date
    • ≥1 diagnosis of asthma in the primary or secondary position during the pre-mepolizumab period or on index date
    • ≥2 medical or pharmacy claims for mepolizumab within the first 6 months on or after the index date
    Exclusion criteria:
    • ≥1 diagnosis of any of the following conditions in the primary or secondary position at any time during the study period: a. Active tuberculosis b. Cystic fibrosis
    • ≥1 medical or pharmacy claim for mepolizumab at any time prior to the index date
    • ≥1 medical or pharmacy claim for omalizumab, reslizumab, benralizumab, dupilumab, or tezepelumab during the post-mepolizumab period

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    2024-28-02
    Actual study completion date
    2024-28-02

    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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