Last updated: 12/20/2024 12:22:16

A real-world evidence study of mepolizumab therapy in Slovakia

GSK study ID
213805
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: Study to describe the patient population and the clinical treatment outcomes of patients with severe eosinophilic asthma receiving mepolizumab therapy in Slovakia (SK)
Trial description: Mepolizumab (Nucala) is indicated in Slovakia for severe eosinophilic asthma as subcutaneous (SC) injection and available from 2017, and is associated with significant reductions in exacerbation rates, dependency on and daily dose of oral corticosteroids (OCS), as well as reduced blood and sputum eosinophil count as compared to placebo in participants with severe eosinophilic asthma. This retrospective non-interventional chart review study will describe the participant population and the clinical treatment outcomes of participants with severe eosinophilic asthma receiving mepolizumab therapy in Slovakia, based on health record data from allergologists and pulmonologists clinics. The Baseline and follow-up data will be collected from the records between 01-Nov-2016 and 31-Mar-2019. The data collected will enable better understanding of broader picture of benefits connected with mepolizumab therapy in Slovakia from clinical and health-economic perspectives and will be valuable source of real-world evidence for local physicians and payers. Nucala is a registered trademark of the glaxosmithkline group of companies.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with Baseline demographic characteristics

Timeframe: Baseline (within 12 months prior to first dose)

Number of participants with pharmacotherapy indicated for asthma

Timeframe: Baseline (within 12 months prior to first dose)

Number of participants with significant change in laboratory measures

Timeframe: Baseline (within 12 months prior to first dose) and at 2, 6 and 12-months

Number of participants with significant change in lung function tests

Timeframe: Baseline (within 12 months prior to first dose) and at 2, 6 and 12-months

Number of participants with asthma exacerbations

Timeframe: Up to 12 months

Secondary outcomes:

Change in maintenance OCS dose (milligrams [mg])

Timeframe: Baseline (within 12 months prior to first dose) and up to 12 months

Change in annual number of exacerbations

Timeframe: Baseline (within 12 months prior to first dose) and up to 12 months

Percentage of OCS dependent participants

Timeframe: Baseline (within 12 months prior to first dose) and up to 12 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-31-01
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Milos Jesenak, Vaclav Vanecek, Martina Ondrusova, Veronika Urdova, Katarina Dostalova, Ludek Hochmuth. Real-world outcomes of mepolizumab treatment in severe eosinophilic asthma patients - retrospective cohort study in Slovakia. Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia. 2023-Sep;167(3): 272-280. PMID: 37439266 DOI: 10.5507/bp.2023.029
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
July 2020 to January 2021
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants, either male of female 18 years or older with a diagnosis of asthma.
  • Participants with prescribed Mepolizumab during routine clinical practice (in line with reimbursement criteria in Slovakia) with treatment initiation between 01-Nov-2017 and 31-Jan-2019.
  • Participants younger than 18 years of age.
  • Participants without a diagnosis of asthma.
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants, either male of female 18 years or older with a diagnosis of asthma.
  • Participants with prescribed Mepolizumab during routine clinical practice (in line with reimbursement criteria in Slovakia) with treatment initiation between 01-Nov-2017 and 31-Jan-2019.
  • Participants requiring at least 12 prescriptions of Nucala.
Exclusion criteria:
  • Participants younger than 18 years of age.
  • Participants without a diagnosis of asthma.
  • Mepolizumab treatment initiated before 01-Nov-2017 or after 31-Jan-2019.

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
2021-31-01
Actual study completion date
2021-31-01

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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