Last updated: 10/21/2021 05:40:05

Real World Effectiveness study of mepolizumab in Severe Eosinophilic AsthmaREDES

GSK study ID
213172
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: Real World Effectiveness study of mepolizumab in Severe Eosinophilic Asthma in Spain
Trial description: Severe asthma is a heterogeneous disease with an unclear prevalence, however mepolizumab had shown a benefit in the reduction of exacerbations and oral corticosteroids (OCS), but since it's been approved, it's also shown the benefit of add-on mepolizumab in Quality of Life, asthma control, Lung function. Depending on the region, or even the hospital, participants need to meet a variable threshold of blood eosinophil counts and a different number of exacerbations, to be eligible for treatment with mepolizumab. Taking advantage of the availability of these measurements in all sites, subgroup analyses of exacerbations reduction by eosinophil counts could help us further understand the different burden of disease, at different levels of asthma severity. For this study, participant's data will be collected from the source documents like medical records containing demographic data, medical, treatment and diagnostic documentation and laboratory assessments, and from the medical charts. Severe asthma participants who are currently on a biologic therapy are closely managed by their specialists. During a data collection period of 3 months, investigators will select consecutively, all their eligible participants who meet the inclusion criteria. The observational period includes 12 months pre- and 12 months post-mepolizumab initiation. The 3-months data collection period will be after the post-treatment period.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Reduction in the annualized exacerbation rate 12 months post-treatment with respect to 12 months pre-treatment period

Timeframe: Up to 12 months

Number of exacerbations in 12 months prior to the treatment initiation with mepolizumab

Timeframe: Up to 12 months

Secondary outcomes:

Reduction in exacerbations requiring emergency room (ER) visit/ hospitalization visit in 12 months prior to initiation of treatment with mepolizumab

Timeframe: Up to 12 months

Reduction in exacerbations requiring emergency room (ER) visit/ hospitalization visit in 12 months post-initiation of treatment with mepolizumab

Timeframe: Up to 12 months

Reduction in exacerbations requiring hospitalization visit in 12 months prior to initiation of treatment with mepolizumab

Timeframe: Up to 12 months

Reduction in exacerbations requiring hospitalization visit in 12 months post-initiation of treatment with mepolizumab

Timeframe: Up to 12 months

Reduction in OCS daily dose for all participants

Timeframe: Up to 12 months

Change in Forced Expiratory volume in 1 second (FEV1)

Timeframe: Up to 12 months

Change in Asthma Control Test (ACT) score at indicated time points

Timeframe: Up to 12 months

Change in rescue medication

Timeframe: Up to 12 months

Change in night awakenings

Timeframe: Up to 12 months

Number of participants with common (>=5%) Adverse events

Timeframe: Up to 12 months

Healthcare resource utilization

Timeframe: Up to 12 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-04-08
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Rivas CD, Carrillo Díaz T, Blanco Aparicio M, Moragón EM, Banas D, Sánchez Herrero MG. REal worlD Effectiveness and Safety of mepolizumab in a multicentric Spanish cohort of asthma patients stratified by eosinophils: the REDES Study. Drugs. 2021; DOI: 10.1007/s40265-021-01597-9 PMID: 34586602
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
November 2019 to August 2020
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants with an investigator's diagnose of severe uncontrolled eosinophilic asthma for more than equal to 18 years.
  • Written informed consent.
  • Participants who have participated in an interventional asthma study in the 12 months prior to or after Baseline (12 months before or after mepolizumab initiation).
  • Participants with missing key clinical information to define the primary endpoint.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Clinical study report
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English

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
2020-04-08
Actual study completion date
2020-04-08

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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