Last updated: 07/03/2026 07:40:26

Comparative Effectiveness Study of Mepolizumab Versus Omalizumab

GSK study ID
310011
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Impact of Mepolizumab Versus Omalizumab on Asthma Outcomes among Patients with Medicare Fee-for-Service Insurance in the United States
Trial description: The study will evaluate and compare the impact of mepolizumab versus omalizumab on asthma-related hospitalizations and asthma exacerbations in participants with asthma. Medical and pharmaceutical claims data of Medicare Free-for-Service (FFS) beneficiaries with will be utilized.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of Asthma-related Hospitalizations Per Participant Year (PPY)

Timeframe: Up to approximately 77 months after treatment initiation

Number of Asthma-related Hospitalizations PPY Up to 12 Months After Treatment Initiation

Timeframe: Up to 12 months after treatment initiation

Number of Asthma-related Hospitalizations PPY Up to 24 Months After Treatment Initiation

Timeframe: Up to 24 months after treatment initiation

Secondary outcomes:

Number of Asthma Exacerbations PPY

Timeframe: Up to approximately 77 months after treatment initiation

Number of Asthma-related Hospitalizations PPY Following Persistent Use of Mepolizumab or Omalizumab for at Least 6 Months After Initiation

Timeframe: Up to approximately 77 months after treatment initiation

Number of Asthma Exacerbations PPY Following Persistent Use of Mepolizumab or Omalizumab for at Least 6 Months After Initiation

Timeframe: Up to approximately 77 months after treatment initiation

Interventions:
Not applicable
Enrollment:
Not applicable
Observational study model:
Cohort
Primary completion date:
2026-20-10
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
July 2026 to October 2026
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Great than or equal to (>=) 2 consecutive medical or pharmacy claims for the same biologic agent (either mepolizumab or omalizumab) on or after January 1, 2019
  • The first observed claim will be defined as the index date and the second claim must occur within 6 months of the index date
  • >=1 diagnosis for cystic fibrosis, lung cancer, interstitial lung disease, or alpha-1 antitrypsin deficiency during the baseline period or on the index date
  • >=1 medical or pharmacy claim for mepolizumab, omalizumab, reslizumab, benralizumab, dupilumab, or tezepelumab any time prior to the index date

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Planned
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

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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