Last updated: 07/12/2021 08:40:08

Effectiveness of mepolizumab in subgroups of asthma participants

GSK study ID
213145
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: The Impact of Mepolizumab Maintenance Therapy on Exacerbation Rate in Subgroups of Asthma Patients
Trial description: This study will be conducted to describe the effectiveness of mepolizumab in participants with pre-existing comorbid conditions within seven subgroups of asthma participants (atopic, chronic sinusitis, depression/anxiety, obesity, nasal polyps, chronic obstructive pulmonary disease [COPD], and respiratory infections) by characterizing changes in the rate of asthma exacerbations, oral corticosteroid use (OCS), and exacerbation-related healthcare resource use. In this study participants data will be included from MarketScan Commercial and Medicare Supplemental Databases wherein they have administered mepolizumab during the period of 01-Nov-2015 to 31-Dec-2017; and the first medical or pharmacy claim for mepolizumab administration will be the index date. Continuous enrollment with medical and pharmacy benefits will be required for the 12 months before and after the index date.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Rate of asthma exacerbations

Timeframe: Up to 1 year

Secondary outcomes:

Number of participants with OCS use

Timeframe: Up to 1 year

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-31-01
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Casale T, Molfino N, Silver J, Bogart M, Packnett E, McMorrow D, Wu J, Hahn B. Real-world effectiveness of mepolizumab in patients with severe asthma and associated comorbidities. Ann Allergy Asthma Immunol. 2021; DOI: 10.1016/j.anai.2021.05.021 PMID: 34038773
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
December 2019 to January 2020
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Mepolizumab administration between 01-Nov-2015 and 31-Dec-2017. Date of the first administration during the participant identification period will be considered the index date.
  • At least 12 months of continuous enrollment with medical and pharmacy benefits before the index date (Baseline period). Index date will be included in the Baseline period.
  • Evidence of mepolizumab use during the 12-month Baseline period.
  • Evidence of omalizumab, reslizumab, benralizumab, or dupilumab use (as assessed by Healthcare Common Procedure Coding System [HCPCS] or National Drug Code [NDC] codes, ) during the 12-month Baseline period.
Inclusion and exclusion criteria
Inclusion criteria:
  • Mepolizumab administration between 01-Nov-2015 and 31-Dec-2017. Date of the first administration during the participant identification period will be considered the index date.
  • At least 12 months of continuous enrollment with medical and pharmacy benefits before the index date (Baseline period). Index date will be included in the Baseline period.
  • At least 12 months of continuous enrollment with medical and pharmacy benefits after the index date (follow-up period).
  • At least 12 years of age on the index date.
  • >=1 asthma diagnosis on a non-diagnostic medical claim in any position during the 12-month Baseline period.
  • >=2 mepolizumab administrations during the first 6 months of the follow-up period.
  • Non-diagnostic medical claim for one of the seven medical conditions of interest during the 12-month Baseline period.
Exclusion criteria:
  • Evidence of mepolizumab use during the 12-month Baseline period.
  • Evidence of omalizumab, reslizumab, benralizumab, or dupilumab use (as assessed by Healthcare Common Procedure Coding System [HCPCS] or National Drug Code [NDC] codes, ) during the 12-month Baseline period.
  • 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
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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
2020-31-01
Actual study completion date
2020-31-01

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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