Last updated: 04/07/2025 05:30:13

Nucala impact on SCS complications

GSK study ID
218950
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: Impact of Mepolizumab versus Chronic Systematic Corticosteroid (SCS) Use among Patients with Severe Asthma: A Real-World Assessment of SCS-Related Complications and Associated Healthcare Resource Utilization in the US
Trial description: The primary purpose of the study is to evaluate and compare Systemic corticosteroids (SCS)-related complications (including acute and chronic complications) among mepolizumab users versus chronic SCS users. The index date will be the date of the first claim for belimumab. The observation period will span from the index date to the earliest of end of continuous eligibility or end of data availability, whichever comes first.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of Participants with SCS-Related Complications

Timeframe: Up to 12 months

Secondary outcomes:

Number of Participants with Healthcare Resource Utilization

Timeframe: Up to 12 months

Healthcare Costs

Timeframe: Up to 12 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2024-30-08
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 August 2024
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • For Mepolizumab Users:
  • For greater than or equal to (>=) 2 medical or pharmacy claims for mepolizumab on or after November 4, 2015 (The first observed claim will be defined as the index date and the second claim needs to be within 6 months of the index date)
  • For Mepolizumab Users:
  • >= 1 medical or pharmacy claim for a biologic approved for asthma other than mepolizumab (that is, omalizumab, reslizumab, benralizumab, or dupilumab) during the baseline, landmark, or follow-up periods
Inclusion and exclusion criteria
Inclusion criteria:

    For Mepolizumab Users:

    • For greater than or equal to (>=) 2 medical or pharmacy claims for mepolizumab on or after November 4, 2015 (The first observed claim will be defined as the index date and the second claim needs to be within 6 months of the index date)
    • >= 12 months of continuous eligibility prior to the index date (the 12 months preceding the index date will be defined as the baseline period)
    • >= 12 months of continuous eligibility after the index date For Chronic Systematic Corticosteroid (SCS) Users:
    • >= 6 months of continuous use of oral or parenteral SCS with an average daily dose equivalent to >= 6 milligrams (mg) of prednisone (The first dispensing/administration of this continuous use period will be defined as the index date if the date is on or after November 4, 2015)
    • >= 12 months of continuous eligibility prior to the index date (The 12 months preceding the index date will be defined as the baseline period)
    • >= 12 months of continuous eligibility after the index date
    • >= 2 diagnoses of asthma during the baseline period or on the index date
Exclusion criteria:

    For Mepolizumab Users:

    • >= 1 medical or pharmacy claim for a biologic approved for asthma other than mepolizumab (that is, omalizumab, reslizumab, benralizumab, or dupilumab) during the baseline, landmark, or follow-up periods For Chronic SCS Users:
    • >= 1 medical or pharmacy claim for mepolizumab, omalizumab, reslizumab, benralizumab, or dupilumab during the baseline, landmark, or follow-up periods

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
2024-30-08
Actual study completion date
2024-30-08

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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