Last updated: 10/21/2021 05:40:05
Real World Effectiveness study of mepolizumab in Severe Eosinophilic AsthmaREDES
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Participants with an investigator's diagnose of severe uncontrolled eosinophilic asthma for more than equal to 18 years.
- Written informed consent.
- Participants that initiated add-on treatment with mepolizumab more than or equal to12 months before data collection date and have continuous follow up since treatment initiation (i.e. participants visit regularly every 3 months or every 6 months to evaluate disease control).
- Availability of continuous follow up information in medical records of 12 months pretreatment period.
Exclusion criteria:
- 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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website