Last updated: 12/02/2024 07:20:21

Nucala impact on Inhaled corticosteroids (ICS) and Short-acting beta-agonists (SABA) sparing

GSK study ID
218947
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: Inhaled Corticosteroids, Short-Acting Beta-Agonists, and Oral Corticosteroids Sparing and Its Determinants Among Severe Eosinophilic Asthma Patients on Mepolizumab
Trial description: This is a retrospective, longitudinal, pre/post study design. The index date is defined as the date of mepolizumab initiation. The baseline period is defined as the 12-month period prior to the index date. The observation period is defined as the 12-month period after the index date. This study aims to provide real-world evidence on ICS, SABA, and Oral corticosteroids (OCS) sparing after mepolizumab initiation and the determinants of changes in utilization patterns of ICS, SABA, and OCS.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Proportion of participants prescribed with Inhaled corticosteroids (ICS)

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

Secondary outcomes:

Proportion of participants prescribed with SABA, or OCS

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

Number of participants with prescribed SABA canisters

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

Number of days of supply for ICS or OCS

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

Mean daily dose of ICS

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

Mean daily dose of OCS

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

Number of participants with reasons for change in utilization of ICS, SABA, or OCS

Timeframe: 12 months post-dose

Number of participants with demographics and clinical characteristics, and physician characteristics associated with Responders vs Persisters

Timeframe: 12 months post-dose

Responsible party for change in utilization of ICS, SABA, or OCS

Timeframe: 12 months post-dose

Number of participants with use of medications other than ICS, SABA and OCS

Timeframe: 12 months post-dose

Interventions:
  • Drug: Mepolizumab
    • Enrollment:
    0
    Primary completion date:
    2024-30-05
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    mepolizumab
    Collaborators
    Not applicable
    Study date(s)
    July 2023 to May 2024
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • At least one prescription of mepolizumab for asthma between November 4, 2015, and April 30, 2022; the first prescription during this period will be defined as the index date
    • Greater than or equal to (≥)2 prescriptions of mepolizumab in the first six months after the index date
    • ≥1 diagnosis (primary or secondary) of any cancer of the respiratory and intrathoracic system (e.g., lung cancer, pleural mesothelioma, esophageal cancer, thymic tumors, lymphoma, neurogenic tumors) at any time during the study period
    • ≥1 diagnosis of active tuberculosis or cystic fibrosis at any time during the study period
    Inclusion and exclusion criteria
    Inclusion criteria:
    • At least one prescription of mepolizumab for asthma between November 4, 2015, and April 30, 2022; the first prescription during this period will be defined as the index date
    • Greater than or equal to (≥)2 prescriptions of mepolizumab in the first six months after the index date
    • Physician documented diagnosis of asthma prior to or on the index date
    • At least one prescription of ICS, SABA, or OCS during the baseline period
    • ≥12 months of medical records prior to the index date (i.e., ≥1 visit, in-person or virtual, that occurred >12 months prior to the index date)
    • ≥12 months of medical records after the index date (i.e., ≥1 visit, in-person or virtual, that occurred >12 months after the index date) except if patient died
    Exclusion criteria:
    • ≥1 diagnosis (primary or secondary) of any cancer of the respiratory and intrathoracic system (e.g., lung cancer, pleural mesothelioma, esophageal cancer, thymic tumors, lymphoma, neurogenic tumors) at any time during the study period
    • ≥1 diagnosis of active tuberculosis or cystic fibrosis at any time during the study period
    • Use of any other biologics for asthma (omalizumab, reslizumab, benralizumab, dupilumab, or tezepelumab) at any time during the study 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
    2024-30-05
    Actual study completion date
    2024-30-05

    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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