Last updated: 11/28/2022 08:10:11

Effect of mepolizumab on life threatening asthma

GSK study ID
209656
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 in Patients with Life Threatening Asthma
Trial description: Asthma is a chronic respiratory disorder, differentiated by hyperactive and inflamed airways that can be mild, moderate, or severe. Severe asthma has substantial economic impact on community due to the direct costs accompanying illness. The United States (US) Food and Drug Administration (FDA) approved mepolizumab in November 2015 for add-on maintenance treatment in subjects 12 years or older with severe asthma. The present retrospective, observational study will investigate the effect of mepolizumab treatment on the rate of asthma exacerbations in subjects with life threatening asthma. The main aim of this study is to compare the change in the total number of asthma exacerbations among subjects receiving mepolizumab in the year prior to mepolizumab administration to the year following mepolizumab administration. Subjects with an administration of mepolizumab between November 1, 2015 and December 31, 2017, identified using MarketScan® database, will be included in the study.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change in annual rate of asthma exacerbation

Timeframe: 24 months (12 months before administration of mepolizumab and 12 months after administration of mepolizumab)

Secondary outcomes:

Number of subjects with any oral corticosteroid (OCS) use

Timeframe: 24 months (12 months before administration of mepolizumab and 12 months after administration of mepolizumab)

Number of subjects with OCS pharmacy prescriptions

Timeframe: 24 months (12 months before administration of mepolizumab and 12 months after administration of mepolizumab)

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2019-02-12
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Silver J, Molfino N, Bogart M, Packnett E, McMorrow D, Wu J, Hahn B. Real-world impact of mepolizumab in patients with life-threatening asthma: US insurance claims database analysis. Clin Ther. 2021; DOI: 10.1016/j.clinthera.2021.10.010 PMID: 34893348
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
September 2019 to December 2019
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Subjects with mepolizumab administration between November 1, 2015 and December 31, 2017. The date of the first claim for mepolizumab during the subject identification period will be considered as the index date.
  • Subjects with at least 12 months of continuous enrollment with medical and pharmacy benefits before the index date (Baseline period).
  • Subjects with evidence of mepolizumab use during the 12 month Baseline period.
  • Subjects 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 or follow-up period.
Inclusion and exclusion criteria
Inclusion criteria:
  • Subjects with mepolizumab administration between November 1, 2015 and December 31, 2017. The date of the first claim for mepolizumab during the subject identification period will be considered as the index date.
  • Subjects with at least 12 months of continuous enrollment with medical and pharmacy benefits before the index date (Baseline period).
  • Subjects with 12 months of continuous enrollment with medical and pharmacy benefits in the year prior to the index date (baseline period) and following the index date (follow-up period).
  • Subjects with at least 12 years of age on the index date.
  • Subjects with >=1 asthma diagnosis in any position on a non-diagnostic medical claim during the 12 month Baseline period.
  • Subjects with >=2 mepolizumab administrations during the first 6 months of the follow-up period.
  • Subjects meeting the criteria for life-threatening asthma defined as; >=3 asthma exacerbations during Baseline and/or >=1 hospitalization with an asthma diagnosis in the primary position during Baseline and/or >=1 medical claim with evidence of endotracheal intubation identified using all available claims history in the MarketScan database while the subject had continuous enrollment prior to the index date and/or OCS dose >10 milligram (mg) prednisone equivalent in the 90 days prior to the index date.
Exclusion criteria:
  • Subjects with evidence of mepolizumab use during the 12 month Baseline period.
  • Subjects 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 or 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
2019-02-12
Actual study completion date
2019-02-12

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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