Last updated: 12/07/2021 12:00:08

Impact of Mepolizumab Maintenance Therapy

GSK study ID
212695
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 Maintenance Therapy on Inhaled Corticosteroids Use
Trial description: Asthma is a common chronic respiratory disorder that affects millions of children and adults. Asthma is characterized by periodic exacerbations by chronically hyperactive and inflamed airways that can be mild, moderate, or severe. This is a retrospective study of participants receiving mepolizumab between 01 November 2015 and 31 March 2018 and will describe the number of participants with high dose inhaled corticosteroids (ICS) group at initiation of Nucala® and follow their use of ICS dose over the course of a year and describe outcomes of exacerbation rate, oral corticosteroids (OCS) and Short-acting Beta Agonists (SABA). The data will be collected using MarketScan® Commercial and Medicare Supplemental Database. MarketScan is a registered trademark of Thomson Reuters (Healthcare) Inc. Nucala is a registered trademark of GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with change in ICS dosage

Timeframe: Up to 12 months

Secondary outcomes:

Number of participants with asthma exacerbations

Timeframe: Up to 12 months

Number of participants with OCS burst

Timeframe: Up to 12 months

Number of participants with chronic OCS use

Timeframe: Up to 12 months

Number of participants with one or more claim for SABA or SABA/Short-acting Muscarinic Antagonists (SAMA) use

Timeframe: Up to 12 months

Mean number of SABA or SABA/SAMA claims

Timeframe: Up to 12 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-07-05
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Corren J, Silver J, Molfino N, Bogart M, Packnett E, McMorrow D, Wu J, Hahn B. A real-world study of ICS use in patients with severe eosinophilic asthma treated with mepolizumab. Ann Allergy Asthma Immunol. 2021;S1081-1206(21):01219-9 DOI: 10.1016/j.anai.2021.11.005 PMID: 34774737
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
February 2020 to May 2020
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Participants with mepolizumab administration between 01 November 2015 and 31 March 2018. Date of the first administration during the participant identification period will be considered the index date.
  • Participants with at least 12 months of continuous enrollment with medical and pharmacy benefits before the index date (Baseline period).
  • Participants with evidence of mepolizumab use during the 12-month Baseline period.
  • Participants with evidence of omalizumab, reslizumab, benralizumab, or dupilumab use (as assessed by Healthcare Common Procedure Coding System [HCPCS] or National Drug Code [NDC]) during the 12-month Baseline period.
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants with mepolizumab administration between 01 November 2015 and 31 March 2018. Date of the first administration during the participant identification period will be considered the index date.
  • Participants with at least 12 months of continuous enrollment with medical and pharmacy benefits before the index date (Baseline period).
  • Participants with at least 12 months of continuous enrollment with medical and pharmacy benefits after the index date (follow-up period).
  • Participants with at least 12 years of age on the index date.
  • Participants with greater than or equal to 1 asthma diagnosis on a non-diagnostic medical claim in any position during the 12-month baseline period.
  • Participants with greater than or equal to 2 mepolizumab administrations during the first 6 months of the follow-up period.
  • Participants with evidence of high dose ICS use in the last 90 days of the Baseline period.
Exclusion criteria:
  • Participants with evidence of mepolizumab use during the 12-month Baseline period.
  • Participants with evidence of omalizumab, reslizumab, benralizumab, or dupilumab use (as assessed by Healthcare Common Procedure Coding System [HCPCS] or National Drug Code [NDC]) during the 12-month Baseline period.
  • Participants with evidence of omalizumab, reslizumab, benralizumab, or dupilumab use during the 12-month follow-up period.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Clinical study report
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
2020-07-05
Actual study completion date
2020-07-05

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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